Today, more than ever, we are intensely grateful to be supporting our partners in the life sciences. Many of our colleagues are working tirelessly around the clock all over the world in an effort to save lives affected by the COVID-19 pandemic. Clinical trials have been accelerated, Coronavirus tests are being improved and vaccines are being created globally.
At Sales-Link, Inc., we are dedicated to presenting you with the latest news and advancements reported by our colleagues in their efforts to combat this pandemic. Please check back often; we will be updating regularly.
Please click on the links below for additional information and full articles:
July 20, 2020 - STAT - by Matthew Herper, Damian Garde and Helen Branswell
Studies provide glimpse at efficacy of Covid-19 vaccines from Oxford-AstraZeneca and CanSino
Excerpt: Covid-19 vaccine being developed by Oxford University and the drug giant AstraZeneca generated an immune response in a study of roughly 1,000 patients, according to interim results published Monday.
The data, published in the medical journal the Lancet, also show that the vaccine caused side effects, including fever, headaches, muscle aches, and injection site reactions, in about 60% of patients. All of the side effects were deemed mild or moderate, and all resolved themselves over the course of the study.
While the Oxford-AstraZeneca vaccine, known as AZD1222, has moved most rapidly into larger-scale studies of any major contender — and AstraZeneca has said that billions of doses could be manufactured — the new data represent the first glimpse researchers have gotten at its efficacy. They show a relatively safe vaccine — though side effects were greater than for a meningitis vaccine, to which it was compared — that engages the immune system to fight the virus. AstraZeneca said that, because of the results, it is likely that future studies will test giving patients two doses of the vaccine.
The Lancet also published results of another vaccine, from the Chinese biotech CanSino, that had been previously released. The Phase 2 results showed that, as was seen in the Phase 1 data, the vaccine-induced neutralizing antibody responses — which could be vital to preventing the disease’s dangerous symptoms — in most subjects. But further study continues to show that this vaccine works better in some people than others. And among those it didn’t work as well in, were people aged 55 and older, a key target for Covid-19 vaccination.
July 14, 2020 - National Institutes of Health
Experimental COVID-19 vaccine safe, generates immune response
Excerpt: NIH-sponsored Phase 1 trial tested mRNA vaccine. An investigational vaccine, mRNA-1273, designed to protect against SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), was generally well tolerated and prompted neutralizing antibody activity in healthy adults, according to interim results published online today in The New England Journal of Medicine. The ongoing Phase 1 trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine is being co-developed by researchers at NIAID and at Moderna, Inc. of Cambridge, Massachusetts. Manufactured by Moderna, mRNA-1273 is designed to induce neutralizing antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells.
The trial was led by Lisa A. Jackson, M.D., MPH, of Kaiser Permanente Washington Health Research Institute in Seattle, where the first participant received the candidate vaccine first participant received the candidate vaccineon March 16. This interim report details the initial findings from the first 45 participants ages 18 to 55 years enrolled at the study sites in Seattle and at Emory University in Atlanta. Three groups of 15 participants received two intramuscular injections, 28 days apart, of either 25, 100, or 250 micrograms (mcg) of the investigational vaccine. All the participants received one injection; 42 received both scheduled injections.
In April, the trial was expanded to enroll adults older than age 55 years; it now has 120 participants. However, the newly published results cover the 18 to 55-year age group only.
Regarding safety, no serious adverse events were reported. More than half of the participants reported fatigue, headache, chills, myalgia, or pain at the injection site. Systemic adverse events were more common following the second vaccination and in those who received the highest vaccine dose. Data on side effects and immune responses at various vaccine dosages informed the doses used or planned for use in the Phase 2 and 3 clinical trials of the investigational vaccine.
The interim analysis includes results of tests measuring levels of vaccine-induced neutralizing activity through day 43 after the second injection. Two doses of vaccine prompted high levels of neutralizing antibody activity that were above the average values seen in convalescent sera obtained from persons with confirmed COVID-19 disease.
A Phase 2 clinical trial of mRNA-1273, sponsored by Moderna, began enrollment in late May. Plans are underway to launch a Phase 3 efficacy trial in July 2020.
June 16, 2020 - from The New York Times - by Benjamin Mueller and Roni Caryn Rabin
Common Drug Reduces Coronavirus Deaths, Scientists Report
Excerpt: A steroid, dexamethasone, is the first drug shown to help save severely ill coronavirus patients, according to scientists in Britain.
In an unexpected sign of hope amid the expanding pandemic, scientists at the University of Oxford said on Tuesday that an inexpensive and commonly available drug reduced deaths in patients with severe Covid-19, the illness caused by the coronavirus.
If the finding is borne out, the drug, a steroid called dexamethasone, would be the first treatment shown to reduce mortality in severely ill patients. Had doctors been using the drug to treat the sickest Covid-19 patients in Britain from the beginning of the pandemic, up to 5,000 deaths could have been prevented, the researchers estimated.
In severe cases, the virus directly attacks cells lining the patient’s airways and lungs. But the infection also can prompt an overwhelming immune reaction that is just as harmful. Three-quarters of hospitalized Covid-19 patients receive some form of oxygen.
The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third and deaths of patients on oxygen by one-fifth.
June 16, 2020 - from Sky News - by Greg Heffer
Coronavirus: Oxford University vaccine to provide protection 'for about a year', says drugmaker
Excerpt: AstraZeneca has joined forces with the UK government to support a COVID-19 vaccine developed by the University of Oxford. Human trials of the vaccine are underway, with the firm already having reached agreements to supply around two billion doses across the world.
Pascal Soriot, AstraZeneca's chief executive, told Belgian radio on Tuesday that a phase one trial of the vaccine in Britain was due to end soon, while a phase three trial has already begun.
A phase three trial is usually the final phase in the clinical development of a vaccine and sees the vaccine given to thousands of people to be tested for efficacy and safety.
Commenting on the likely protection the Oxford vaccine will provide, Mr. Soriot told broadcaster Bel RTL: "We think that it will protect for about a year."
He added: "If all goes well, we will have the results of the clinical trials in August/September. We are manufacturing in parallel.
June 11, 2020 - from Fierce Biotech - by Nick Paul Taylor
Regeneron starts testing COVID-19 antibody cocktail in humans
Excerpt: Regeneron has begun clinical development of its anti-SARS-CoV-2 antibody combination REGN-COV2. The adaptive phase 1/2/3 clinical trials will assess the effects of the antibodies on hospitalized and nonhospitalized COVID-19 patients.
Having validated the application of its platform to infectious diseases with an Ebola drug, Regeneron quickly emerged as a front-runner in the race to develop antibodies against the coronavirus. Eli Lilly ultimately became the first company to get an anti-SARS-CoV-2 antibody candidate into humans, but Regeneron has followed close behind by hitting its mid-June target.
Regeneron is kicking its clinical development program off with two trials, one in hospitalized patients and another in nonhospitalized patients. In the first part of the trial, Regeneron will look at virologic and safety endpoints before adding clinical endpoints into the mix in phase 2. The phase 1 and 2 trials will inform the design and size of phase 3 studies in each population.
(updated) June 9, 2020 - from The New York Times - by Noah Weiland and David E. Sanger
Trump Administration Selects Five Coronavirus Vaccine Candidates as Finalists
Excerpt: The Trump administration has selected five companies as the most likely candidates to produce a vaccine for the coronavirus, senior officials said, a critical step in the White House’s effort to deliver on its promise of being able to start widespread inoculation of Americans by the end of the year.
The five companies are Moderna, a Massachusetts-based biotechnology firm, which Dr. Fauci said he expected would enter into the final phase of clinical trials next month; the combination of Oxford University and AstraZeneca, on a similar schedule; and three large pharmaceutical companies: Johnson & Johnson, Merck, and Pfizer. Each is taking a somewhat different approach.
June 2, 2020 - from Indian Express - by Express Web Desk
Excerpt: Coronavirus (Covid-19) vaccine latest update- With developing a safe, effective and accessible vaccine for Covid-19 being seen as the key to containing the pandemic, research and trials are going on at a fast pace across the world to find a cure for the novel coronavirus.
In the latest developments, US company Moderna Inc, one of the front runners in the vaccine race, has said it had started dosing patients in a mid-stage study while Russian scientists plan to start clinical trials within two weeks.
Around 120 vaccines are in the works across the world, of which at least 10 are undergoing human trials even as cases worldwide crossed the 61 lakh mark, including 372,566 deaths. To date, China’s CanSino adenovirus vaccine, Oxford University’s adenovirus vaccine, Moderna’s mRNA vaccine, and Novavax have emerged as the topmost promising vaccine candidates for Covid-19.
June 2, 2020 - from Fierce Pharma - by Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner
Coronavirus tracker: Fred Hutch fights COVID, too; Indian drugmakers stalled on remdesivir
Excerpt: Houston Methodist unveiled positive phase 1 results with its plasma therapy for COVID-19 patients. Indian drugmakers, on the other hand, can't move forward on making Gilead Sciences' remdesivir without local government approval—and so far that OK hasn't been forthcoming.
Convalescent plasma is the latest potential treatment for COVID-19 to emerge successfully from phase 1 trials, according to new data published by the Houston Methodist Medical Center. Seventy-six percent of patients who received plasma therapy showed improvement with no adverse side effects reported.
Tom Lynch, three months into his tenure as Fred Hutchinson Cancer Research Center chief, says its prior virology work puts Hutch in an ideal position to help track the novel coronavirus, develop tests, create trials and more. The center has already launched studies to track the virus on its own campus and nearby, and plans to open a COVID-19 clinical research center later this summer.
Indian drugmakers are eager for government approval to start making remdesivir under license from Gilead Sciences, but pricing and dosage are two major holdups.
June 1, 2020 - from Gilead Press Release
Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19
Excerpt: Gilead Sciences, Inc. today announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group (OR 1.65 [95% CI 1.09-2.48]; p=0.017). The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
May 21. 2020 - from CBS News (Video)
Harvard doctor shares "good news" on coronavirus immunity studies
Excerpt: Harvard Global Health Institute Director Dr. Ashish Jha explains the promising findings of several recent studies that found monkeys and humans can develop coronavirus immunity, and what the results mean for a possible vaccine.
May 20, 2020 - from BioSpace - by BioSpace Editorial Staff
Biopharma Update on the Novel Coronavirus: May 20
Excerpt: Genentech launched a new COVID-19 clinical study with an eye toward increasing diversity and inclusion among patients treated. The study was launched following reports from the U.S. Centers for Disease Control and Prevention, as well as other sources, that indicate the COVID-19 pandemic may be disproportionately affecting underserved and minority populations. With these health disparities in mind, Genentech has initiated the EMPACTA (Evaluating Minority Patients with Actemra) trial. This is a phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of Actemra (tocilizumab) in patients hospitalized with COVID-19 pneumonia at hospitals that largely treat underserved and minority patient populations.
California-based Prellis Biologics announced it generated 300 human IgG antibodies that bind to either the S1 or S2 spike protein of the SARS-CoV2-Wuhan strain of the novel coronavirus with its Prellis Externalized Human Immune System technology. The company said it produced 960 synthetic human lymph nodes that were challenged with a SARS-CoV2 vaccine-like cocktail, leading to virus-specific antibody generation. The next step for the company is to determine if the generated antibodies will prevent virus replication in live cell assays.
May 18, 2020 - from The Boston Globe - by Jonathan Saltzman
Moderna says first-stage study of coronavirus vaccine produced antibodies in subjects
Excerpt: Moderna said Monday that the vaccine the Cambridge biotech helped develop for COVID-19 produced antibodies in the blood of eight volunteers comparable to those seen in people who recovered from the disease.
The company’s chief medical officer, Dr. Tal Zaks, said the initial results from the first phase of a clinical trial suggest that the vaccine “has the potential to prevent COVID-19 disease.”
Scientists suspect that antibodies found in the blood of people who recover from the new coronavirus may make them immune to reinfection, but that has not been proven yet.
A few dozen volunteers participated in the first stage of the study, but Moderna said data were available for only a small portion of them.
May 18. 2020 - from STAT News - by Helen Branswell
Early data show Moderna Covid-19 vaccine generates immune response
Excerpt: A candidate vaccine for Covid-19 developed by the drug maker Moderna appears to generate an immune response similar to the response seen in people who have been infected by the virus and recovered, the company said Monday.
In a Phase 1 trial, eight patients who received two doses of the vaccine at the lowest and middle doses tested — 25 and 100 micrograms — developed neutralizing antibodies to the virus at levels similar to people who had recovered from infection, the company said in a statement.
The data were limited and from only a small number of participants in the trial, led by the National Institute of Allergy and Infectious Diseases. But they are still likely to be seen as encouraging. Research aimed to develop a vaccine against SARS, a related virus responsible for a 2002-2003 outbreak, showed that neutralizing antibodies are pivotal for achieving protection.
Moderna is developing the vaccine in conjunction with the NIAID’s Vaccine Research Center.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 μg,” said Tal Zaks, Moderna’s chief medical officer.
May 16, 2020 - from FDA Press Release
Excerpt: The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit.
May 15, 2020 - from The New York Times - by Mike Baker
F.D.A. Halts Coronavirus Testing Program Backed by Bill Gates
Excerpt: SEATTLE — An innovative coronavirus testing program in the Seattle area — promoted by the billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus — has been ordered by the federal government to stop its work pending additional reviews.
The program involved sending home test kits to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns. Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases.
But the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.
“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the F.D.A. wrote in a memo.
The delay is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up.
May 14, 2020 - from National Public Radio - by Joe Neel and Hannah Hangeman
FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test
Excerpt: The Food and Drug Administration is cautioning the public about the reliability of a widely used rapid test for the coronavirus. The test, made by Abbott Laboratories, has been linked with inaccurate results that could falsely reassure patients that they are not infected with the virus.
The Trump administration has promoted the test as a key factor in controlling the epidemic in the U.S., and it's used for daily testing at the White House.
As first reported on NPR, as many as 15 to 20 out of every 100 tests may produce falsely negative results. A study released this week indicated that the test could be missing as many as 48% of infections.
The FDA issued the alert on the Abbott test "in the spirit of transparency." In a press release, the agency said it's investigating whether the false-negative results could be connected to the type of swab used in the test or the material the samples are stored in for transport.
It also cautions that "any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test."
"We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Dr. Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health. "We will continue to study the data available and are working with the company to create additional mechanisms for studying the test."
May 12, 2020 - from Fierce Pharma - by Eric Sagonowsky
Excerpt: With at least eight COVID-19 vaccines in human testing and headlines touting their progress each day, a top U.S. health official voiced some optimism about one or more of them working.
At a Tuesday Senate hearing about the path forward from pandemic lockdowns, NIAID director Anthony Fauci said there’s “no guarantee” any of the vaccines in testing will be effective, but he has “cautious optimism” one or more might work.
Researchers have “multiple shots on goal” and should know more about whether the programs can provide protection against the novel coronavirus in the late fall or early winter, he added.
There are unknowns, Fauci cautioned, including whether any of the vaccines might actually make infections worse. Other experts, such as SVB Leerink analyst Geoffrey Porges, have argued that current COVID-19 vaccine development timelines and expectations are overly optimistic.
Even as scientists work to learn more about the virus and potential vaccines, officials are taking steps to assist the programs along the development path and prep for a possible rollout if any succeed.
During the hearing, FDA Commissioner Stephen Hahn testified that regulators are looking at a common preclinical development pathway for early projects and a “master trial protocol” to simultaneously test numerous candidates.
Regulators plan to review about 10 vaccine programs through phase 2, Hahn said, and advance four or five of them into phase 3 testing, where researchers look for efficacy in a large group of trial participants.
May 12, 2020 - from Geek Wire - by Alan Boyle
Excerpt: The coronavirus vaccine trial that started out in Seattle is progressing well enough to get onto Food and Drug Administration’s fast track for development, with planning well underway for the next two phases of testing.
Seattle’s Kaiser Permanente Washington Health Research Institute kicked off the Phase I clinical trial, which focuses on ensuring that the vaccine is safe for humans.
The first participants got their shots in mid-March, and last month, the trial was expanded to Emory University in Atlanta and the National Institute of Allergy and Infectious Diseases’ Vaccine Research Clinic in Bethesda, Md. NIAID is funding the trial, and the vaccine was developed by Moderna Therapeutics.
Last week, Moderna said the Phase I results were so encouraging that the FDA gave the go-ahead for Phase II trials, which involve administering the vaccine to 600 volunteers and finding out whether it sparks the desired immune response.
Today, Moderna said the FDA issued fast-track authorization, and NIAID director Anthony Fauci gave the vaccine his vote of confidence during a Senate hearing. “If we are successful, we hope to know that in the late fall or early winter,” Fauci said.
Plans are already being made for Phase III trials. “My team is actually spending most of the time now preparing for Phase III that they say could start in early summer,” Moderna CEO Stephane Bancel said during a CNBC interview.
May 12, 20202 - from Clinical Trials Arena - by GlobalData Healthcare
Covid-19 vaccine development is picking up pace, supported by government and private funds
Excerpt: Vaccine development to fight Covid-19 is picking up pace, as more and more companies are starting clinical trials and forming collaborations to ensure rapid development and sufficient production capacity. The number of vaccine candidates and techniques in development raises optimism, but the history of vaccine development shows that setbacks and roadblocks are almost certain and a finished product is unlikely to be widely available in 2020. Although Gilead released positive but inconclusive data from its trial of the antiviral remdesivir, a vaccine is still the ultimate goal to prevent future Covid-19 outbreaks.
On Monday, May 3, a global coalition led by EU member states, Canada, Japan, Saudi Arabia, the UK, and Norway pledged $8B for the development of Covid-19 vaccines and to ensure universal global access. The World Bank, the Bill and Melinda Gates Foundation, and other wealthy donors contributed. Meanwhile, the US created its own project, “Operation Warp Speed”, which aims to spend several billion dollars to produce enough doses of a potential vaccine to protect the US population.
Among the companies starting to test their Covid-19 vaccine candidates in clinical trials is German biotech BioNTech, which partnered up with Pfizer to develop its messenger ribonucleic acid (mRNA) vaccine. Phase I/II clinical trials of the vaccine started in Germany at the end of April, and the first US patients were dosed in the first week of May. The study is investigating the right dosage, safety, and immunogenicity for four different versions of the vaccine candidate BNT-162. In China, BioNTech struck a deal with Fosun Pharma to test and produce the vaccine candidate.
(Read the full article to learn about five other important clinical trials that are underway.)
May 11, 2020 - from Stanford Medicine - by Bruce Goldman
Stanford Medicine researchers lead clinical trial of interferon-lambda for COVID-19
Excerpt: Scientists at Stanford Medicine are investigating whether a molecule called interferon-lambda can help people with mild cases of COVID-19 feel better and reduce their transmission of the disease-causing virus.
A clinical trial is underway at Stanford Medicine to determine whether a drug can keep people who’ve just tested positive for the coronavirus out of the hospital, help them recover faster, and make them safer to be around in the meantime.
The researchers also want to know whether the drug stems viral shedding, which would reduce transmission to family members and the community.
The drug being looked at, interferon-lambda is a manufactured form of a naturally occurring protein that’s been given in previous clinical trials to more than 3,000 people infected with hepatitis viruses.
“Its safety profile appears to be excellent,” said principal investigator Prasanna Jagannathan, MD, assistant professor of infectious diseases at the School of Medicine. He is co-leading the study with Upinder Singh, MD, professor of infectious diseases and of microbiology and immunology at the school.
Results in laboratory settings and in animals also suggest that lambda-interferon may be helpful in controlling viruses that cause respiratory illnesses such as influenza and SARS, an often fatal disease. It may also help snuff out other common viral infections.
May 11, 2020 - from Anadolu Agency - by Riyaz ul Khaliq
Japan eyes COVID-19 vaccine trials in July
Excerpt: Japan is expecting to begin clinical trials for a vaccine to treat coronavirus in July, the country’s prime minister said on Monday.
Addressing the budget committee in parliament, Shinzo Abe revealed that work on vaccines are being carried on several institutions, including the University of Tokyo, Osaka University, and the National Institute of Infectious Diseases.
Noting vaccine trials had already begun outside the country, Abe said: “I hope vaccination programs can get underway at the earliest possible date by gathering the world's wisdom,” Japan’s public broadcaster NHK reported.
Japan is under state emergency since last month to boost its fight against the deadly infection.
Abe added that his government is aiming to approve the anti-flu drug Avigan to treat COVID-19 by the end of this month.
Early in March, Avigan received praise from China National Center for Biotechnology Development which said the drug produced by Japan's Fujifilm Holdings has been "effective against COVID-19" boosting shares of the company over 15% that day.
Last week, the Abe government approved another anti-viral drug -- remdesivir, originally developed as a possible treatment for Ebola -- for use against the deadly coronavirus, thus making it the country’s first official drug to treat coronavirus.
It was one of the fastest steps against COVID-19 that Japan took just three days after the Japanese unit of US developer Gilead Sciences Inc. filed an application for approval.
Early this month, the US authorized emergency use of the drug for COVID-19 patients.
May 9, 2020 - from The Food and Drug Administration - by Stephen M. Hahn, M.D. and Dr. Jeffrey E. Shuren, MD, JD
Excerpt: The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The EUA was issued late Friday to Quidel Corporation for the Sofia 2 SARS Antigen FIA. This test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.
Diagnostic testing is one of the pillars of our nation’s response to COVID-19 and the FDA continues to take action to help make these critical products available, including by issuing EUAs. During this pandemic, there have been two types of tests for which the FDA has issued EUAs. One type are polymerase chain reaction (PCR) tests, a molecular diagnostic testing technique that detects the genetic material from the virus and can help diagnose an active COVID-19 infection. The other type are serological tests that look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection (serological, or antibody, tests should not be used to diagnose active infection).
This latest FDA authorization is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19. Each category of diagnostic test has its own unique role in the fight against this virus.
May 8, 2020 - from The National Institutes of Health - Press Release
Excerpt: A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun. The trial is now enrolling hospitalized adults with COVID-19 in the United States. The trial is expected to open at approximately 100 U.S. and international sites. Investigators currently anticipate enrolling more than 1,000 participants. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial.
The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT), which began on Feb. 21 to evaluate remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc. That trial closed to enrollment on April 19 after recruiting 1,063 participants at 47 U.S. and 21 international sites. An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 and shared their preliminary analysis with the study sponsor, NIAID. Their analysis showed that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received a placebo. More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report. In this next trial with baricitinib, called ACTT 2, all participants will receive remdesivir or remdesivir with baricitinib.
“We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Anthony S. Fauci, M.D. “ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”
May 8, 2020 - from The Food and Drug Administration - Press Release
FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
Excerpt: Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory-developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”
May 6, 2020 - from Bloomberg News - by Corinne Gretler and John Lauerman
Infecting Subjects May Speed COVID Vaccine Studies, WHO Says
Excerpt: Deliberately infecting healthy volunteers with the virus that causes Covid-19 may speed studies of vaccines against the deadly pathogen, the World Health Organization said.
Such studies, which pose significant potential dangers to subjects, may be considered in dire situations and with certain disclosures and protections, a working group of the United Nations health agency said in a report posted Wednesday on its website.
Researchers around the world are racing to develop vaccines to protect against the deadly coronavirus and allow countries to rebuild teetering economies. So-called challenge studies, where treatments or preventatives are tested directly against the infection in informed volunteers, might speed the path of vaccines to the public.
Challenge studies “can be substantially faster to conduct than vaccine field trials,” according to the working group paper, “in part because far fewer participants need to be exposed to experimental vaccines in order to provide (preliminary) estimates of efficacy and safety.”
Challenge studies hold the potential to reduce coronavirus mortality around the world but pose significant potential dangers for volunteers, scientists led by Marc Lipsitch, a Harvard School of Public Health epidemiologist, suggested in a recent paper.
From the Editors at Sales-Link, Inc. - As of May 7, 2020, 14,183 people from 102 countries have volunteered to participate in COVID-19 Human Challenge Trials, which deliberately expose the participants to the Coronavirus in order to speed up the development of a vaccine. If you are interested in volunteering or learn about the potential impact of COVID-19 Human Challenge Trials and read some of the reasons volunteers give for deciding to participate, look on the 1 Day Sooner website.
May 6, 2020 - from KETV Omaha - by Sean Everson
Omaha company conducting clinical research trial for potential COVID-19 vaccine
Excerpt: Doctors say the ultimate goal in combatting COVID-19 is finding a vaccine that works, but in the meantime, it's critical to find people for clinical trials.
Meridian Clinical Research in Omaha has been doing vaccine trials for more than 20 years. Now, they're asking for participants to help find a COVID-19 vaccine.
"There are several vaccines out there in development and we're hopefully in the process of being able to support all of those," said Andrew Kimball, VP of Business Development at Meridian Clinical Research.
Kimball said they're looking for 50 to 100 healthy adults over the age of 19 in the Omaha area to participate in a clinical trial to test a potential COVID-19 vaccine.
"The first trials look like they should begin sometime in mid to late May, and then we expect to have several potential programs moving forward all they through to probably the end of the year," Kimball said.
May 5, 2020 - from The New York Times - by Knvul Sheikh
Pfizer Begins Human Trials of Possible Coronavirus Vaccine
Excerpt: Pfizer and the German pharmaceutical company BioNTech announced that their potential coronavirus vaccine began human trials in the United States on Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September.
The two firms are jointly developing a vaccine candidate based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, the vaccine could potentially tell cells how to make the spike protein of the coronavirus without actually making a person sick.
Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection. The technology also has the advantage of being faster to produce and tends to be more stable than traditional vaccines, which use weakened virus strains.
Moderna, Inovio, CanSino, and several other pharmaceutical companies are trying similar approaches, some of which began the first phase of tests in humans a few weeks ago. But no vaccine made with this technology for other viruses has ever reached the global market.
May 5, 2020 - from NBC News - by Tom Costello and Tim Stelloh
Pfizer, NYU working on innovative coronavirus vaccine that could be ready by end of summer
Excerpt: Researchers at Pfizer Inc. and New York University are working on a never-before-tried coronavirus vaccine that the pharmaceutical company says could be available by September.
The vaccine, which carries genetic code known as messenger RNA, attempts to reprogram the deadly pathogen rather than manipulate the live virus.
"It is probably the fastest way of having a vaccine available to stem this pandemic, based on the data that I have seen," said Kathrin Jansen, who leads vaccine research for Pfizer.
The vaccine instructs a person's cells to make proteins associated with the coronavirus without making the person sick. Researchers hope the body's immune system will then kick in, creating the antibodies needed to fight off COVID-19.
"Messenger RNA is something the body produces on its own normally," said Mark Mulligan, chief of infectious diseases at NYU Langone Health. "It's kind of a new thing, but it's really not anything that's too different from what the body does for itself."
May 3, 2020 - from Market Watch - by Lina Saigol
Excerpt: British drugmaker AstraZeneca has teamed up with the University of Oxford to develop and manufacture a vaccine for coronavirus, in a move that could allow for rapid vaccination around the world if the treatment proves to be effective.
Human trials of the vaccine developed by the university’s Jenner Institute and Oxford Vaccine Group entered phase-one testing last week, with hundreds of people aged 18 to 55 volunteering across five trial centers in southern England.
“As COVID-19 continues its grip on the world, the need for a vaccine to defeat the virus is urgent,” Pascal Soriot, chief executive of AstraZeneca said in a statement on Thursday.
Speaking to BBC radio, Soriot said: “It is definitely a risk to launch into the development of the vaccine but now is the time to those kinds of risks.”
“By June, July we will already have a very good idea of the direction of travel in terms of its potential efficacy,” he added.
May 1, 2020 -from The Guardian
Coronavirus US live: FDA approves experimental drug remdesivir for emergency use
Excerpt: The Food and Drug Administration (FDA) has released additional information about its emergency use authorization (EUA) for remdesivir, the anti-viral drug that has shown some promise as a treatment for patients with Covid-19. Donald Trump announced the EUA earlier today.
Use of the drug will be authorized for adults or children who are hospitalized with suspected or confirmed Covid-19 and whose condition is “severe”, meaning they have low blood oxygen levels, need oxygen therapy, or are on a mechanical ventilator, the FDA said.
“Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” the FDA said in its statement.
May 1, 2020 - from Yahoo Finance - by Anjalee Khemlani
How Gilead's coronavirus drug breakthrough is setting the tone for other potential treatments
Excerpt: Gilead Sciences (GILD)’s clinical trial results for a potential coronavirus treatment is being heralded as a breakthrough, largely by helping to blaze a trail for other drugs in the pipeline, while illuminating a path forward in the fight against a “scary” pandemic that’s infected over 3 million around the world.
Three separate studies of Gilead’s remdesivir — including a placebo trial by the National Institute of Allergy and Infectious Disease, which carries far more influence — have helped backstop markets, and sparked hopes that the COVID-19 crisis can be managed. The encouraging results have also opened the door for Gilead to pursue an emergency use authorization from the U.S. Food and Drug Administration.
“There’s a big sense of urgency here, I think the FDA understands the importance of reacting quickly to this,” CEO Daniel O’Day said on an earnings call Thursday. “It’s intense right now and...we think the FDA will move quite quickly on their decision on the labeling side.”
April 29, 2020 - from Reuters Health News - by Deena Beasley, and Manas Mishra
Data on Gilead drug raises hopes in pandemic fight, Fauci calls it 'highly significant'
Excerpt: The top U.S. infectious disease official said Gilead Sciences Inc’s experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped patients recover more quickly from the illness caused by the coronavirus.
Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr. Anthony Fauci as “highly significant.”
“This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.”
“This will be the standard of care,” he said, adding “the FDA ... is working with Gilead to figure out mechanisms to make this easily available to those who need it.”
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said early results from its 1,063-patient trial show that hospitalized COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo.
The study showed a trend toward better survival for remdesivir - 8% of patients given the drug died, compared with 11.6% in the placebo group - but the difference was not statistically significant so may not be due to Gilead’s drug.
“It is the first truly high-powered randomized placebo-controlled trial,” Fauci said.
April 29. 2020 - from The New York Times
Excerpt: The F.D.A. plans to announce as early as Wednesday an emergency use authorization for remdesivir, an experimental antiviral drug that is being tested in treating patients with Covid-19, the disease caused by the coronavirus, according to a senior administration official.
Ahead of the announcement President Trump and Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, on Wednesday hailed early trial results of the drug, holding out hope that it could help stem the rising death toll.
Meeting with reporters at the White House, Dr. Fauci cautioned that the results of the study overseen by his agency, the National Institute of Allergy and Infectious Disease, still need to be properly peer-reviewed but expressed optimism that it could make a difference in speeding up the recovery of some patients infected with the virus.
April 28, 2020 - from WLWT News, Cinncinati
Cincinnati Children's hosts clinical trials for coronavirus vaccine
Excerpt: Cincinnati Children's Hospital will host clinical trials for a COVID-19 vaccine, hospital officials said Tuesday.
The hospital will begin conducting vaccine tests for Pfizer, a multinational pharmaceutical corporation headquartered in New York.
Drugmaker Pfizer said earlier this month that it's taking steps to accelerate coronavirus vaccine development and hopes to begin human trials by the end of the month.
According to CNBC, the company is working on an experimental vaccine that contains genetic material called messenger RNA, or mRNA, which instructs the body's own cellular mechanisms for making proteins to make those that mimic the virus proteins.
It would, therefore, produce an immune response.
The company estimates it could produce hundreds of millions of doses in 2021 if the vaccine is successful.
The blunt reality is the coronavirus will linger until a vaccine is developed, Ohio's top medical officials said, and it may be more than a year before the state and the nation return fully to normal.
April 27, 2020 - from The Wall Street Journal - by Joseph Walker
Drug Study Halted Early for Certain Covid-19 Patients After No Benefit Seen
Excerpt: Regeneron, Sanofi to continue study for patients who require ventilators or other high-flow oxygen support.
Regeneron Pharmaceuticals Inc. and Sanofi SA said Monday they will shut down part of a study exploring whether their arthritis therapy could treat certain hospitalized Covid-19 patients because the drug looked unlikely to help them.
An early look at ongoing results indicated the therapy, named Kevzara, wasn’t helping patients who were hospitalized with a severe form of COVID-19 but don’t require a ventilator’s assistance with breathing, the companies said.
April 27, 2020 - from The New York Times - by David D. Kirkpatrick
In Race for a Coronavirus Vaccine, an Oxford Group Leaps Ahead
Excerpt: In the worldwide race for a vaccine to stop the coronavirus, the laboratory sprinting fastest is at Oxford University.
Most other teams have had to start with small clinical trials of a few hundred participants to demonstrate safety. But scientists at the university’s Jenner Institute had a head start on a vaccine, having proved in previous trials that similar inoculations — including one last year against an earlier coronavirus — were harmless to humans.
That has enabled them to leap ahead and schedule tests of their new coronavirus vaccine involving more than 6,000 people by the end of next month, hoping to show not only that it is safe, but also that it works.
The Oxford scientists now say that with an emergency approval from regulators, the first few million doses of their vaccine could be available by September — at least several months ahead of any of the other announced efforts — if it proves to be effective.
April 26, 2020 - from Richmond Times-Dispatch - by Bridget Batch
Excerpt: As of Friday, VCU had enrolled 38 people in trials to test two drugs, remdesivir and sarilumab.
“Everybody stopped what they were doing and really focused on [COVID-19],” said Dr. F. Gerard Moeller, who chairs the committee at VCU that reviews new clinical trials.
Studies on two experimental drugs were approved in days rather than the usual weeks or months it would usually take, he said.
Currently, the trials are only for people whose COVID-19 is serious enough for them to be hospitalized, and doctors determine which trial to enroll a patient based on the specifics of the case.
“We’re not jumping steps; we’re just working nights and weekends to make things happen,” said Abbate, emphasizing the importance of not disregarding safety. “I am optimistic that we will have treatments within months. I’m just not sure which one it will be.”
Remdesivir is an antiviral drug that has not been approved but has been used experimentally to treat Ebola and tested in animals with other diseases caused by different kinds of coronaviruses.
The company that manufactures the drug, Gilead Sciences Inc., announced hopeful results on April 10 that the drug had shown improvement in 68% of a small group of 53 patients with severe complications of COVID-19 treated through a clinical trial.
But the World Health Organization accidentally published findings from a trial that took place in China that found no benefit from the drug. The findings were inconclusive, however, because the study was ended early, Stat News reported Thursday. Remdesivir is also being tested at clinical trials at HCA Henrico Doctors’ Hospital and the University of Virginia Medical Center.
Sarilumab is approved for treating rheumatoid arthritis and is focused not on fighting the novel coronavirus directly, but on calming an overactive inflammatory response to the virus that damages the body.
April 26, 2020 - from The New York Post - by Carl Campanile and Tamar Lapin
New York clinical trial testing heartburn medication as coronavirus treatment
Excerpt: A clinical trial is underway at major New York hospitals to test the efficacy of heartburn medication, in combination with the anti-malarial drug hydroxychloroquine, on coronavirus patients, The Post has learned.
More than 150 people so far are taking part in the study, which began earlier this month and is being conducted by the Feinstein Institutes for Medical Research, the research arm of Northwell Health, according to a spokesman for the hospital system.
Researchers are trying to find out whether famotidine — the active compound in the over-the-counter heartburn drug Pepcid — acts as an inhibitor of COVID-19, similar to the way certain drugs block the replication of HIV/AIDS.
Patients in the study are being given the heartburn drug intravenously along with hydroxychloroquine at Northwell’s North Shore University Hospital, Long Island Jewish Medical Center and Lenox Hill Hospital, said David Battinelli, vice president and chief medical officer of Northwell.
The researchers initially wanted to test famotidine on its own, but with so many patients now being treated with hydroxychloroquine, they wouldn’t have had enough test subjects, they told Science Magazine, which first reported the study.
April 26. 2020 - from BBC News - by Soutik Biswas
Coronavirus: How India will play a major role in a Covid-19 vaccine
Excerpt: US Secretary of State Mike Pompeo said last fortnight that India and the US were working together to develop vaccines against the coronavirus.
Mr. Pompeo's remark didn't entirely come as a surprise.
The two countries have run an internationally recognized joint vaccine development program for more than three decades.
They have worked on stopping dengue, enteric diseases, influenza, and TB in their tracks. Trials of a dengue vaccine are planned in the near future.
India is among the largest manufacturer of generic drugs and vaccines in the world. It is home to half a dozen major vaccine makers and a host of smaller ones, making doses against polio, meningitis, pneumonia, rotavirus, BCG, measles, mumps, and rubella, among other diseases.
Now half a dozen Indian firms are developing vaccines against the virus that causes Covid-19.
One of them is Serum Institute of India, the world's largest vaccine maker by number of doses produced and sold globally. The 53-year-old company makes 1.5 billion doses every year, mainly from its two facilities in the western city of Pune. (It has two other small plants in the Netherlands and the Czech Republic.) Around 7,000 people work for the firm.
The company supplies some 20 vaccines to 165 countries. Some 80% of its vaccines are exported and, at an average of 50 cents a dose, they are some of the cheapest in the world.
Now the firm has stitched up collaboration with Codagenix, an American biotech company, to develop a "live attenuated" vaccine, among the more than 80 reportedly in development all over the world.
April 25, 2020 - from STAT News - by Lois Privor-Dumm, Naor Bar Zeev, and Maria Deloria Knoll
The success of a Covid-19 vaccine will hinge on its delivery
Excerpt; A vaccine must produce sufficient protection in older populations, given the age-related deterioration of the immune system, called immune senescence.
But the focus on the therapy itself can obscure complicated issues surrounding its delivery. They will be equally decisive in determining whether a vaccine can vanquish this virus.
For example, it is currently unclear how many doses will be needed to fight a disease that will have already expanded into most of the human population. The number of people who have developed natural immunity by the time vaccines arrive will determine whether we need millions or billions of doses. Rapidly producing billions of doses vastly exceeds current vaccine production capacity and would likely require costly repurposing of other facilities, or building even more expensive new manufacturing plants. Yet uncertainty about demand can make it difficult to secure sufficient investment at a fair price per dose.
Although hundreds of millions of dollars for vaccine development have already have been promised through the combined efforts of the Coalition for Epidemic Preparedness Innovation; Gavi, the Vaccine Alliance; and their partners at the World Health Organization, World Bank, UNICEF; and the Bill & Melinda Gates Foundation, the investment needed for vaccine development is $2 billion.
April 24, 2020 - from The New York Times - by William J. Broad
Could the Power of the Sun Slow the Coronavirus?
Excerpt: A study suggests that ultraviolet rays could slow the virus, though not enough to wipe it out, and not as a treatment.
Will summertime slow the virus that causes Covid-19, as it has done with many other viruses that sow flu, colds and pneumonia? A new study finds that it may, though not enough to wipe out the pathogen or keep the pandemic from resurging in the fall.
The study, done by ecological modelers at the University of Connecticut, understands the main natural weapon against the novel germ to be ultraviolet light — an invisible but energetic part of the sun’s electromagnetic spectrum that’s well-known for damaging DNA, killing viruses and turning healthy human skin cells into cancerous ones.
“We found that ultraviolet light was most strongly associated with lower Covid-19 growth rates,” the scientists wrote in a publication that has not yet been peer-reviewed and that went online late Wednesday. Projections of the overall effects, they continued, suggest that the disease “will decrease temporarily during summer, rebound by autumn, and peak next winter.” But they cautioned that uncertainty about the study’s projected outcomes “remains high.”
April 24, 2020 - from CNN News - by Dr. Sanjay Gupta
Excerpt: Despite all his medical knowledge, 31-year-old medical student and Ph. D. candidate Sean Doyle couldn't know for certain all the risks of the injection he had just received in his right shoulder at Emory University Hospital. Yes, of course, he was told of the potential side effects, such as soreness in his arm, a fever, malaise. But when you are among the first people in the world to receive a vaccine injection, the real answer about the risks is simply "we don't know."
In fact, it's those very questions that he is helping us answer.
Sean is helping all of us figure out if it is safe, by putting up his hand first and volunteering. With that injection, Sean had become a critical part of the fastest moving vaccine trials in the history of the world, a vaccine for Covid-19.
During a pandemic, the urgency is understandable. In just a few months, the virus has spread to nearly every corner of the globe and sadly taken more lives than several wars or natural disasters combined. It is also true that no one on the planet is immune to this; such is the nature of a novel or new coronavirus.
April 24, 2020 - from Market Watch - by Callum Keown
Oxford University scientists reveal coronavirus vaccine timeline as human trial begins
Excerpt: A coronavirus vaccine being developed by Oxford University has begun human trials with the first two patients being injected with the potential vaccine.
Two volunteers were injected on Thursday, with one receiving the vaccine and the other receiving a control - a widely available meningitis vaccine, the University said. The pair will be monitored for 48 hours before six more people enter the trial on Saturday and a larger number will join at the beginning of next week.
Researchers said if transmission in the community remains high they may have enough data to see if the vaccine works “in a couple of months”, but if transmission levels drop it could take up to six months. Scientists at Oxford have previously said the aim is to produce a million doses of the vaccine by September.
Around 1,110 people will take part in the trial with half being injected with control and half with the vaccine. Professor Sarah Gilbert, who is leading the Oxford vaccine team, has previously said she’s “80% confident” the vaccine will work.
April 24, 2020 - from ABC News - by Guy Davies and Nadine Shubailat
Clinical trials for coronavirus vaccine begin at University of Oxford
Excerpt: The first patients have been enrolled in human trials for a coronavirus vaccine at the historic University of Oxford after the U.K.’s Health Secretary said the country would be "throwing everything" behind the project.
The clinical trial will test the effects of possible COVID-19 treatments and the start the process of vaccine evaluation in the university’s first human studies.
Earlier this week, the Health Secretary Matt Hancock announced a total of £52.5 million (about $65 million) worth of funding for the project, and another vaccine trial at London’s Imperial University due to begin in June.
April 23, 2020 - From BBC News
Hopes dashed as coronavirus drug remdesivir 'fails first trial'
Excerpt: There had been widespread hope that remdesivir could treat Covid-19.
But a Chinese trial showed that the drug had not been successful, according to draft documents accidentally published by the World Health Organization.
The drug did not improve patients' condition or reduce the pathogen's presence in the bloodstream, it said. The US firm behind the drug, Gilead Sciences, said the document had mischaracterized the study.
News of the failed trial spread after the WHO posted details on its clinical trials database before it was removed. The WHO has since confirmed the draft report was mistakenly uploaded.
It showed that researchers studied 237 patients, administering the drug to 158 and comparing their progress with the remaining 79, who received a placebo.
After a month, 13.9% of the patients taking the drug had died compared to 12.8% of those receiving the placebo. The trial was stopped early because of side-effects.
"Remdesivir was not associated with clinical or virological benefits," the summary states.
April 22, 2020 - from Georgia Health News via WABE Public Radio - by Andy Miller
Emory Patients Part Of Drug Trial For Potential COVID-19 Treatment
Excerpt: Some Emory patients with COVID-19 are part of a clinical trial of an antiviral drug that has reportedly proved effective among patients in Chicago who have severe illness.
The Emory trial of remdesivir is part of a National Institutes of Health study that’s separate from the Chicago drug trial.
There’s no FDA-approved treatment for COVID-19 , but remdesivir is getting a lot of positive buzz in scientific circles.
The University of Chicago trial was reported by STAT to show rapid recoveries in fever and respiratory symptoms of COVID-19 patients.
Emory has more than 80 patients involved in its part of the randomized NIH trial. The patients were hospitalized and diagnosed with pneumonia caused by COVID-19, said Dr. Aneesh Mehta, who is Emory’s principal investigator.
April 22, 2020 - from Pharma Dive - by Ned Pagliarulo
Coronavirus vaccine from BioNTech, Pfizer set to enter testing in Germany
Excerpt: Healthy volunteers in Germany will soon receive one of several versions of an experimental coronavirus vaccine developed by BioNTech and partner Pfizer, after regulators in the country cleared a clinical study to begin.
The trial, which will enroll some 200 adults, is the first study of a coronavirus vaccine to begin in Germany, and one of only six ongoing worldwide. BioNTech and Pfizer said they expect to soon receive an OK from the Food and Drug Administration to start human tests of their vaccine prototypes in the U.S.
Pfizer and BioNTech have moved quickly to begin testing the German biotech's vaccine technology in humans. Like Moderna, which was first into the clinic with a potential coronavirus vaccine, BioNTech uses messenger RNA to spur the body's cells to make a non-infectious part of the coronavirus, training the immune system to respond to the real virus.
April 22, 2020 - from NBC News - by Erika Edwards
‘A race against time': Results expected soon on experimental coronavirus drug
Excerpt: The results of a highly anticipated study on an experimental coronavirus treatment for the sickest patients are expected any day.
Physicians leading the clinical trial for the drug, called remdesivir, say the fast-moving pandemic has compelled them to work with haste, all without compromising the scientific rigor necessary to prove whether the drug really works.
"We are in a race against time," Dr. Andre Kalil, a principal investigator for the trial at the University of Nebraska Medical Center, told NBC News. "We're doing everything we can 24/7 to make this happen."
Previous research hinted at the promise of remdesivir, an antiviral drug that's thought to work by blocking the virus from replicating itself in the body. But those studies were either based on animal data or had major caveats, such as lacking a control group.
A study published earlier this month in the New England Journal of Medicine found the drug improved breathing in some patients, but the study was small, with just 53 patients. And its authors did not compare their patients' outcomes with a control group of patients to know for sure whether the improvements were truly due to remdesivir, or whether they would have become better on their own, without treatment.
April 21, 2020 - from Quest Diagnostics - PR Newswire
Quest Diagnostics Begins to Perform COVID-19 Antibody Testing
Excerpt: Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that it has begun to perform antibody testing for coronavirus (COVID-19) using blood samples. With the new service, Quest Diagnostics now provides healthcare providers in the United States access to COVID-19 antibody as well as molecular diagnostic laboratory testing.
Antibodies developed by the body in response to a viral infection may provide potential immunity against future infection. According to the U.S. Food and Drug Administration, COVID-19 antibody testing may indicate that "the person has been exposed to the virus and developed antibodies against it, which may mean that person has at least some immunity to the coronavirus." Antibody testing uses blood serum specimens and is sometimes referred to as serology testing.
The new Quest Diagnostics antibody service uses tests developed for high-throughput lab environments. Initially, Quest is providing the service based on tests from Abbott and EUROIMMUN, a PerkinElmer company. Quest Diagnostics has completed independent validation studies on both tests. Both tests aid in detecting the presence of immunoglobulin class G (IgG). IgG antibody response typically develops by 14 days after symptom onset. In addition, Quest also continues to pursue other platforms that could enable it to increase testing capacity further.
April 20, 2020 - from Fierce Pharma - by Eric Sagonowsky, Kyle Blankenship, Angus Liu, Conor Hale
Excerpt: After committing to donate 130 million doses of hydroxychloroquine globally, Novartis has won FDA clearance to test the antimalarial drug in a large U.S. phase 3 trial as President Donald Trump's endorsement of it in COVID-19 continues to fuel wide debate.
Meanwhile, Alexion Pharmaceuticals said it's planning to test its rare disease drug Ultomiris in severe COVID-19 pneumonia.
The FDA, in collaboration with the CDC and the NIH, will start validating COVID-19 antibody tests beyond the emergency use authorizations it's been using to speed them to market.
April 20, 2020 - from Live Science - by Laura Geggel
Drug used to treat Ebola may help COVID-19 patients, preliminary results suggest
Excerpt: An antiviral drug used to treat Ebola may be an effective medicine for patients with severe COVID-19, very preliminary results from part of a clinical trial suggest.
Of 113 people with severe COVID-19 who were hospitalized at the University of Chicago Medicine, all received daily infusions of remdesivir, an antiviral medicine made by Gilead Sciences, according to Stat News, which broke the story.
"The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish," Dr. Kathleen Mullane, the University of Chicago infectious diseases specialist overseeing the remdesivir studies for the hospital, said in a private video meeting that was leaked to Stat News.
April 17, 2020 - from Market Watch - by Jaimy Lee
Gilead drug produced ‘rapid’ recovery in coronavirus patients, report says
Excerpt: University of Chicago Medicine researchers said they saw “rapid recoveries” in 125 COVID-19 patients taking Gilead Sciences Inc.’s experimental drug remdesivir as part of a clinical trial, according to a Thursday afternoon report.
here are no proven treatments or vaccines for the novel coronavirus which has sickened more than two million people worldwide and killed nearly 150,000 people, but remdesivir is considered a front-runner in the race to develop a treatment for COVID-19 infections that works. Though the findings reported by Stat are promising, they are not based on full clinical trial data from the company.
In a statement, Gilead said the “totality of the data [needs] to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19.”
April 16, 2020 - from Stat News - by Adam Feuerstein and Matthew Herper
Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment
Excerpt: Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.
The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
April 15, 2020 - from CNN Health - by Arman Azad and Drew Griffin
The FDA authorizes 2 more coronavirus antibody tests
Excerpt: The US Food and Drug Administration issued emergency-use authorizations Wednesday for two new coronavirus antibody tests.
The tests can detect past infections after people have recovered. But it's still not clear whether having antibodies means a person has long-term immunity to the virus.
A total of three tests are now authorized by the FDA, which determined that the benefits of using the quickly designed tests during the pandemic outweigh the risks -- such as false negatives or false positives.
The tests, which use blood samples instead of a swab, are limited to use in authorized laboratories. Instead of looking for traces of the virus, they look for the body's response to the virus: antibodies.
But the FDA warns the tests could lead to false negatives because antibodies may not be detectable early in infection.
"A negative result may occur if you are tested early in your illness and your body hasn't had time to produce antibodies to infection," the FDA said in a fact sheet.
Still, experts say the antibody tests can be helpful in understanding how widespread coronavirus really is since they should be able to detect past infections, even if someone had few or no symptoms.
April 15, 2020 - from The Washington Post - by Carolyn Y. Johnson
Chaotic search for coronavirus treatments reveals another shortcoming in pandemic preparation
Excerpt: In a desperate bid to find treatments for people sickened by the coronavirus, doctors and drug companies have launched more than 100 human experiments in the United States, investigating experimental drugs, a decades-old malaria medicine and cutting-edge therapies that have worked for other conditions such as HIV and rheumatoid arthritis.
Development of effective treatments for COVID-19, the disease the virus causes, would be one of the most significant milestones in returning the United States to normalcy. But the massive effort is disorganized and scattershot, harming its prospects for success, according to multiple researchers and health experts. Researchers working around-the-clock describe a lack of a centralized national strategy, overlapping efforts, an array of small-scale trials that will not lead to definitive answers and no standards for how to prioritize efforts, what data to collect or how to share it to get to answers faster.
“It’s a cacophony — it’s not an orchestra. There’s no conductor,” said Derek Angus, chair of the department of critical care medicine at the University of Pittsburgh School of Medicine, who is leading a COVID-19 trial that will test multiple therapies. “My heart aches over the complete chaos in the response.”
April 15, 2020 - from CNBS - by Berkeley Lovelace Jr.
Excerpt: Researchers are working as quickly as science will allow determining whether hydroxychloroquine, a decades-old malaria drug touted by President Donald Trump as a potential “game-changer” in curtailing the COVID-19 pandemic, is effective in fighting the coronavirus.
Federal health regulators have fast-tracked approvals for coronavirus research, allowing scientists across the nation to skip through months of red tape on potential treatments and vaccines for the deadly virus. On March 24, researchers at NYU Langone launched one of the nation’s largest hydroxychloroquine studies and enrolled their first patient 10 days later. It’s one of more than a dozen formal studies in the U.S. looking at the treatment for CV-19, according to ClinicalTrials.gov.
The drug is proven to work in treating Lupus and rheumatoid arthritis, but not COVID-19. A handful of small studies on its use in coronavirus patients published in France and China has raised hope that the drug might help fight the virus.
April 14, 2020 - from Laboratory Equipment - by Michelle Taylor
COVID-19 Treatment Update: Remdesivir, Hydroxychloroquine, Leronlimab, Ivermectin, and More
Excerpt: As the death toll inches closer to 150,000, researchers across the globe are racing against the clock to develop an effective treatment option for patients suffering from COVID-19. There are three main pathways to a treatment solution: adapt an already approved drug, push an experimental drug through a clinical trial, or create an entirely new drug or vaccine. Vaccines are a promising long-term solution, but they typically take 12 to 18 months to create. In the short-term, researchers have been having early success with experimental drugs.
April 13, 2020 - from Reuters - by Christine Soares
Reasons for hope: the drugs, tests and tactics that may conquer coronavirus
Excerpt: With much of the world living in lockdown, the spread of the new coronavirus, SARS-CoV-2, that was first detected in China late last year is beginning to slow in some places. As of April 12, 1.8 million had been infected and 115,000 killed by COVID-19, the disease caused by the virus.
While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials.
Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems. New drugs, together with new diagnostics, antibody tests, patient- and contact-tracing technologies, disease surveillance and other early-warning tools, mean the anticipated next “wave” of the global pandemic does not have to be nearly as bad the first.
More than 70 vaccine candidates are also in development around the world, with at least five in preliminary testing in people.
April 12, 2020 - from The New York Times - by Katie Thomas and Knvul Sheikh
Small Chloroquine Study Halted Over Risk of Fatal Heart Complications
Excerpt: A small study in Brazil was halted early for safety reasons after coronavirus patients taking a higher dose of chloroquine developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia.
Chloroquine is closely related to the more widely used drug hydroxychloroquine. President Trump has enthusiastically promoted them as a potential treatment for the novel coronavirus despite little evidence that they work and despite concerns from some of his top health officials. Last month, the Food and Drug Administration granted emergency approval to allow hospitals to use chloroquine and hydroxychloroquine from the national stockpile if clinical trials were not feasible. Companies that manufacture both drugs are ramping up production.
The Brazilian study involved 81 hospitalized patients in the city of Manaus and was sponsored by the Brazilian state of Amazonas. It was posted on Saturday at medRxiv, an online server for medical articles, before undergoing peer review by other researchers. Because Brazil’s national guidelines recommend the use of chloroquine in coronavirus patients, the researchers said including a placebo in their trial — considered the best way to evaluate a drug — was an “impossibility.”
April 10, 2020 - from NBC News - by Erika Edwards
Experimental drug remdesivir shows potential for coronavirus, early research suggests
Excerpt: Early research shows that an experimental treatment for the coronavirus may help very sick patients improve their breathing, though experts caution that more studies are needed before the drug, remdesivir, can be recommended.
The research, published Friday in The New England Journal of Medicine, looked at 53 coronavirus patients who had been given remdesivir through what’s called "compassionate use."
In a majority of the patients — 68 percent — doctors were able to reduce the amount of oxygen support needed. What's more, 17 of 30 patients who'd been on ventilators were able to come off of those machines. That's important because COVID-19 patients who need to be put on ventilators appear to be more likely to suffer long-term health consequences, and may have worse outcomes.
April 10. 2020 - from FOX News - by Madeline Farber
Clinical trial of potential coronavirus treatment hydroxychloroquine begins, NIH says
Excerpt: A human clinical trial for an antimalarial drug touted as a possible treatment option for patients with COVID-19 infections began this week, according to the National Institute of Health (NIH).
The NIH in a news release on Thursday said a clinical trial for the drug hydroxychloroquine began with the first participants enrolled at Vanderbilt University Medical Center in Nashville, Tenn. The trial involves some 500 adults “who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization,” officials said.
The trial is placebo-controlled and randomized, meaning some of the patients will be treated with hydroxychloroquine while others will not. However, “all participants in the study will continue to receive clinical care as indicated for their condition,” the NIH said.
April 9, 2020 - from USA Today - by Alexa Lardieri
Clinical Trial of Trump’s Coronavirus Drug Begins
Excerpt: A clinical trial to evaluate the safety and efficacy of an anti-malarial drug promoted by the White House as a treatment for the coronavirus is underway, federal officials said Thursday.
The trial of the drug hydroxychloroquine was announced by the National Institutes of Health and enrolled its first patients at Vanderbilt University Medical Center, Nashville, officials said.
President Donald Trump has touted the drug at his daily news briefings, despite warnings from public health authorities who say there is little clinical data to suggest that hydroxychloroquine is an effective treatment for the virus.
Trump's recommendation of the drug, which he has attributed largely to "common sense," has prompted high-profile divisions within the team of advisers working with him on a response to the coronavirus.
Patrice Harris, president of the American Medical Association, told CNN she would not prescribe the medication as a coronavirus treatment and has cited potential risks that include heart rhythm problems.
April 8, 2020 - from The New York Times - by Knvul Sheikh and Katie Thomas
More Coronavirus Vaccines and Treatments Move Toward Human Trials
Excerpt: On Wednesday, Novavax, a Maryland-based biotech company, said it would begin human trials in Australia in mid-May for its vaccine candidate. Novavax is one of more than two dozen companies that have announced promising vaccine programs that are speeding through the early stages of testing unlike ever before.
Also on Wednesday, the stem-cell company Mesoblast said it was starting a 240-patient clinical trial, supported by the National Institutes of Health, that would test whether cells derived from bone marrow could help patients who developed a deadly immune reaction to the coronavirus.
April 6. 2020 - from STAT News - by Andrew Joseph, Adam Feuerstein, Damian Garde and Matthew Herper
Data for Gilead’s potential coronavirus therapy are coming soon. Here’s what you need to know
Excerpt: This month, the world should get the first results from a clinical trial testing the drug remdesivir against Covid-19. They will get a lot of attention.
Remdesivir, made by the California biotech Gilead Sciences, is one of the potential Covid-19 therapies that is furthest along in the development process. The results, from studies in China, could signal whether the drug can effectively combat the infection — and under which circumstances. So far, there is no proven treatment for the coronavirus.
But just how much can be gleaned from these announcements? Will they be the final word on remdesivir? And how can the company supply the drug to patients around the world who might need it?
April 6, 2020 - from CNBC - by Berkeley Lovelace Jr., Noah Higgins and Hannah Higgins-Dunn
WHO says coronavirus vaccine and treatment research has ‘accelerated at incredible speed’
Excerpt: Research to develop vaccines and treatments to fight the coronavirus has “accelerated at incredible speed,” World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said Monday.
He said more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and “about 20 institutions and companies are racing to develop a vaccine.”
“The viral genome was mapped in early January and shared globally which enabled tests to be developed and vaccine research to start,” Tedros said at a news conference at WHO headquarters in Geneva.
April 3, 2020 - from The Guardian - by Laura Spinney
When Will a Coronavirus Vaccine be Ready?
About 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals. The first of these – produced by Boston-based biotech firm Moderna – will enter human trials imminently.
This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of Sars-CoV-2, the virus that causes Covid-19. China shared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick.
April 2, 2020 - from The New York Times - by Apoorva Mandavilli
F.D.A. Approves First Coronavirus Antibody Test in U.S.
Excerpt: The Food and Drug Administration on Thursday approved a new test for coronavirus antibodies, the first for use in the United States.
Currently, available tests are designed to find fragments of viral genes indicating an ongoing infection. Doctors swab the nose and throat and amplify any genetic material from the virus found there.
The new test, by contrast, looks for protective antibodies in a finger prick of blood. It tells doctors whether a patient has ever been exposed to the virus and now may have some immunity.
April 2, 2020 - from USA Today - by Mike Johnson
Tests of Potential Coronavirus Vaccine Spur Growth of Virus-fighting Antibodies
Excerpt: A potential vaccine for COVID-19 has been developed and tested successfully in mice, researchers reported Thursday.
"We'd like to get this into patients as soon as possible," said Andrea Gambotto, associate professor of surgery at the University of Pittsburgh School of Medicine and co-author of a paper announcing the vaccine in the journal EBioMedicine.
As far as reaching clinical trials, "we would like to think a month, give or take. Maybe two months. We just started the process," said co-author Louis Falo, a professor and chairman of the Department of Dermatology at the University of Pittsburgh.
April 1, 2020 - from FierceBiotech - by Ben Adams
Gilead Kickstarts Remdesivir Trials Across the Country
Excerpt: With Prime Minister Boris Johnson infected and isolated in Downing Street, and other top officials similarly afflicted with COVID-19, the U.K. is joining in the testing for Gilead Sciences' much-hyped antiviral candidate remdesivir.
The Big Biotech will launch a series of trial sites for its investigational broad-spectrum drug, originally designed to battle Ebola. As a nucleotide analog that mimics adenosine, one of the building blocks of any RNA virus’s genome, the therapy could also attack SARSCoV-2, the virus causing COVID-19—or so the theory goes.
Armed with the country's urgent public health research (UPHR) status, remdesivir will now start two phase 3 trials—initially at 15 centers up and down the U.K.—to assess how well it can work in patients with moderate to severe COVID-19.
April 1, 2020 - from The New York Times - by Denise Grady
Malaria Drug Helps Virus Patients Improve, in Small Study
Excerpt: The malaria drug hydroxychloroquine helped to speed the recovery of a small number of patients who were mildly ill from the coronavirus, doctors in China reported this week.
Cough, fever and pneumonia went away faster, and the disease seemed less likely to turn severe in people who received hydroxychloroquine than in a comparison group not given the drug. The authors of the report said that the medication was promising, but that more research was needed to clarify how it might work in treating coronavirus disease and to determine the best way to use it.
“It’s going to send a ripple of excitement out through the treating community,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University.
The study was small and limited to patients who were mildly or moderately ill, not severe cases. Like many reports about the coronavirus, it was posted at medRxiv, an online server for medical articles, before undergoing peer review by other researchers.
March 31, 2020 - from The Guardian - by Julia Kollewe
Oxford Firm to Screen 15,000 Drugs in Search for Coronavirus Cure
Excerpt: An Oxford-based firm that uses artificial intelligence to develop new medicines has teamed up with a UK national science facility to screen more than 15,000 drugs for their effectiveness as a treatment for Covid-19.
Exscientia, a spinoff company from the University of Dundee that is now based in Oxford science park, said it had gained access to a large collection of existing drugs held by the Scripps research institute in California and funded by the Bill and Melinda Gates Foundation. It will screen them in partnership with Diamond Light Source near Oxford, which works like a giant microscope and generates bright light that allows scientists to study viruses.
Exscientia hopes to discover a drug that can be repurposed to treat coronavirus within the next six to 12 months, whereupon it would be tested on Covid-19 patients, Prof Andrew Hopkins, the firm’s chief executive, told the Guardian. Any potential treatment could be made available for compassionate use before clinical trials are completed, but this would depend on how much can be manufactured quickly.
March 31, 2020 - from News Public Radio - by Joe Palca
Clinical Trials Set To Determine If Anti-Malaria Drug Effective Against COVID-19
Excerpt: A nationwide trial is underway to see if the drug hydroxychloroquine can prevent disease in people exposed to the novel coronavirus. A second trial will test to see if the drug can prevent severe disease in people who are already showing COVID-19 symptoms.
The trials are being run by David Boulware, an infectious disease scientist at the University of Minnesota. "My normal research is doing clinical trials in Africa for fungal meningitis of the brain," Boulware says. But the COVID-19 demanded his attention. "Somebody needed to do something," he says, "so I got my team together and we sort of jumped on this."
That was on March 9. Eight days later, the trial was up and running. Hydroxychloroquine has been used for decades as a treatment for malaria. The rationale for trying it as a preventative for COVID-19 is based on laboratory studies that show the drug is capable of keeping the coronavirus from entering cells.
March 30, 2020 - from Clinical Trials Arena - by Praveen Duddu
Coronavirus Treatment: Vaccines/Drugs in the Pipeline for COVID-19
Excerpt: The mysterious coronavirus outbreak in the Chinese city Wuhan, now termed as COVID-19, and its fast spread to many other countries, endangers thousands of lives. The pandemic has catalyzed the development of novel coronavirus vaccines across the biotech industry, both by pharmaceutical companies and research organizations such as the National Institutes of Health (NIH), US.
The first COVID-19 vaccine in China is expected to be ready for clinical trials by the end of April, according to Xu Nanping, China’s vice-minister of science and technology. Inovio Pharmaceuticals plans to begin clinical trials on a coronavirus vaccine in April this year.
The National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, as a treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province.
The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19.
March 22, 2020 - from The American Assoc for the Advancement of Science - by Kai Kupferschmidt & Jon Cohen
WHO Launches Global Megatrial of the Four Most Promising Coronavirus Treatments
Excerpt: Could any of these drugs hold the key to saving coronavirus disease 2019 (COVID-19) patients from serious harm or death? On Friday, the World Health Organization (WHO) announced a large global trial, called SOLIDARITY, to find out whether any can treat infections with the new coronavirus for the dangerous respiratory disease. It’s an unprecedented effort—an all-out, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has been designed to be as simple as possible so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate.
With about 15% of COVID-19 patients suffering from severe disease and hospitals being overwhelmed, treatments are desperately needed. So rather than coming up with compounds from scratch that may take years to develop and test, researchers and public health agencies are looking to repurpose drugs already approved for other diseases and known to be largely safe. They’re also looking at unapproved drugs that have performed well in animal studies with the other two deadly coronaviruses, which cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
Drugs that slow or kill the novel coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could save the lives of severely ill patients, but might also be given prophylactically to protect health care workers and others at high risk of infection. Treatments may also reduce the time patients spend in intensive care units, freeing critical hospital beds.
Scientists have suggested dozens of existing compounds for testing, but WHO is focusing on what it says are the four most promising therapies: an experimental antiviral compound called remdesivir; the malaria medications chloroquine and hydroxychloroquine; a combination of two HIV drugs, lopinavir, and ritonavir; and that same combination plus interferon-beta, an immune system messenger that can help cripple viruses. Some data on their use in COVID-19 patients have already emerged—the HIV combo failed in a small study in China—but WHO believes a large trial with a greater variety of patients is warranted.