Exclusive: trial of potential Gilead coronavirus treatment ahead of schedule, says researcher

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(Reuters) – A key US government lawsuit against Gilead Sciences Inc (GILD.O), the experimental treatment for coronaviruses may give results as early as mid-May, according to the study’s principal investigator, after the doctors asked to enroll their patients in the study.

FILE PHOTO: A vial of Ebola drug remdesivir is pictured during a press conference at Eppendorf University Hospital (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues. Ulrich Perrey / File photo

Preliminary results of the randomized trial of remdesivir, an antiviral drug, started in February by the National Institute of Allergies and Infectious Diseases (NIAID), could come even sooner, lead researcher Dr. Andre told Reuters Kalil. There is currently no approved treatment or vaccine for COVID-19, the respiratory disease caused by the new virus that has killed more than 190,000 people worldwide, according to a Reuters report.

Remdesivir has received a lot of attention as a therapy that can change the course of the disease, based on anecdotal reports that it may have helped some patients.

Those hopes were somewhat dashed on Thursday when details of a Chinese trial of remdesivir in patients with severe COVID-19, inadvertently published by the World Health Organization, suggested that it did not offer no benefit.

Gilead backed down on this interpretation, saying that the study, which was stopped early due to low enrollment of patients, cannot provide meaningful conclusions.

Other reports have provided grounds for optimism.

Doctors at Methodist Hospital in Houston told Reuters that since March 23, they have treated 41 COVID-19 patients, most of whom are seriously ill, with the drug. None died and half of them returned home.

But they and other doctors contacted by Reuters said they needed much more information than the few details available in the Chinese lawsuit and anecdotal reports of its emergency use in the United States to make a decision. opinion on remdesivir.

They stressed the need to see how patients receiving remdesivir compare to those who are not receiving treatment in a rigorous clinical trial at different stages of the disease to find out if and under what circumstances it can bring benefit.

The NIAID trial “has all the necessary scientific standards that will really help us define whether this drug works or not,” said Dr. Kalil, professor at the University of Nebraska Medical Center.

This is a randomized, double-blind study in which half of the patients received the drug and the other half received a placebo. Registration for the trial ended on Sunday, but far exceeded initial targets for 400-500 patients, he said.

The investigator has not released the total number of registrations, but the latest public update indicates that the trial size could exceed 800 patients.

The NIAID trial is designed to show whether remdesivir, when given to patients with varying degrees of disease severity, improves outcomes such as length of hospital stay, need for mechanical ventilation, and survival. Dr. Kalil declined to comment specifically on the extent of improvement in these parameters necessary to view the trial as successful and the drug as a viable treatment.

“We are looking for not only a statistical difference, but also a significant clinical improvement,” he said. “We expect to have results from mid-May to the end of May.”

A lack of hard evidence has given American medical associations, as well as the National Institutes of Health, a break. They did not recommend remdesivir to treat COVID-19.

The Infectious Disease Society of America (IDSA), which represents more than 12,000 American specialists, said it would make a formal recommendation once all of the evidence for remdesivir is available.

Dr. Rajesh Gandhi, an infectious disease physician at Massachusetts General Hospital in Boston, who helped write the IDSA guidelines, said most patients with COVID-19 will recover with little or no care medical. He is waiting for more clinical trial data before remdesivir can be considered a useful treatment.

AN EARLY INTERVENTION?

In general, doctors say they would expect remdesivir to work better if given early in the course of the illness. The drug, which had previously failed to treat Ebola, is designed to prevent a virus from replicating in the body and overwhelming a patient’s immune system.

“You can put out a campfire, but once it becomes a forest fire, it’s difficult to control,” said Dr. Kevin Grimes, infectious disease specialist at the Houston Methodist, who is participating in Gilead’s studies.

Gilead is conducting its own trials of remdesivir, which is given to hospital patients with an intravenous drip: one in patients with severe illness and one in patients with more moderate symptoms.

The company has increased the number of patients it will enroll in the critical illness trial to 6,000 from 2,400, and expects results in late April. But this study does not compare remdesivir with another treatment or with a placebo.

Last week, the STAT medical news website reported that almost all of the participants in Gilead-sponsored studies at a University of Chicago hospital experienced a rapid recovery from fever and respiratory symptoms, and many were released in less than a week. The New England Journal of Medicine previously published an analysis showing that two-thirds of a small group of critically ill COVID-19 patients improved after treatment with remdesivir.

FILE PHOTO: A Gilead Sciences, Inc. office is displayed in Foster City, California, United States, May 1, 2018. REUTERS / Stephen Lam

But it is impossible to know if these results can be attributed to the drug in the absence of a control group that was not as far away, because so much is still unknown about this new virus.

Yet these reports provide reason for hope given the desperate need as the virus is unleashed worldwide.

“We were asked to participate in this trial and we jumped on it,” said Grimes. “We see people who are getting sicker and getting better.”

Report by Deena Beasley in Los Angeles; Additional reporting by Michael Erman in New York; Editing by Bill Berkrot

Our standards:Principles of the Thomson Reuters Trust.

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