Remdesivir Coronavirus Trial: Federal Scientists Finally Publish Data

Nearly a month after federal scientists claimed that an experimental drug had helped patients severely ill with the coronavirus, the research has been published.

The drug, remdesivir, was quickly authorized by the Food and Drug Administration for treatment of coronavirus patients, and hospitals rushed to obtain supplies.

But until now, researchers and physicians had not seen the actual data. And remdesivir, made by Gilead Sciences, has a spotty history. It was originally intended to treat hepatitis, but it failed to. It was tested against Ebola, but results were lackluster.

So far, remdesivir has not been officially approved for any purpose. The F.D.A.’s emergency use authorization was not a formal approval.

The long-awaited study, sponsored by the National Institute of Allergy and Infectious Diseases, appeared on The New England Journal of Medicine website on Friday evening. It confirms the essence of the government’s assertions: Remdesivir shortened recovery time from 15 days to 11 days in hospitalized patients. The study defined recovery as “either discharge from the hospital or hospitalization.”

The trial was rigorous, randomly assigning 1,063 seriously ill patients to receive either remdesivir or a placebo. Those who received the drug not only recovered faster but also did not have serious adverse events more often than those who were given the placebo.

It was an international trial, although most sites were in the United States. Patients were assessed daily, and those administering the evaluations did not know whether a patient had been given remdesivir or the placebo.

A monitoring board reviewed the data at specified intervals and called for a halt to the study when there was clear evidence that the drug was effective.

On April 29, N.I.A.I.D. issued a news release stating as much. But infectious disease doctors were frustrated, because they did not have access to the findings, which might have affected how patients were treated.

“For God’s sake, this is a pandemic — we need some data,” said Dr. Judith Feinberg, vice chair of research at West Virginia University School of Medicine.

Publication of the paper has brought some relief. Doctors had been wondering, for instance, whether they should give remdesivir to patients with the most serious Covid-19 cases or to those who weren’t as sick, especially if there were not enough to go around.

Dr. Andre Kalil of the University of Nebraska, a principal investigator of the study, noted that not only do sicker patients fare as well on remdesivir, but their average time to recovery is also slightly faster.

He added that Hispanics, black people and white patients all derived equal benefit from the drug, as did men and women as well as adults in every age group.

The results were the same for patients regardless of whether they had received the drug treatment before or after 10 days of symptoms, said Dr. Helen Chu, of the University of Washington, who was also an investigator of the study.

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  • Frequently Asked Questions and Advice

    Updated May 20, 2020

    • What are the symptoms of coronavirus?

      Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

    • How many people have lost their jobs due to coronavirus in the U.S.?

      Over 38 million people have filed for unemployment since March. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.

    • How can I protect myself while flying?

      If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

    • Is ‘Covid toe’ a symptom of the disease?

      There is an uptick in people reporting symptoms of chilblains, which are painful red or purple lesions that typically appear in the winter on fingers or toes. The lesions are emerging as yet another symptom of infection with the new coronavirus. Chilblains are caused by inflammation in small blood vessels in reaction to cold or damp conditions, but they are usually common in the coldest winter months. Federal health officials do not include toe lesions in the list of coronavirus symptoms, but some dermatologists are pushing for a change, saying so-called Covid toe should be sufficient grounds for testing.

    • Should I wear a mask?

      The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.

    • What should I do if I feel sick?

      If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

    • How can I help?

      Charity Navigator, which evaluates charities using a numbers-based system, has a running list of nonprofits working in communities affected by the outbreak. You can give blood through the American Red Cross, and World Central Kitchen has stepped in to distribute meals in major cities.

The study’s designers changed the outcome measures after the study had began, but they did not have access to the current data. Some critics questioned whether the change had altered the study’s conclusions, but a subsequent analysis determined that it did not.

The disease had a more protracted course than the investigators had realized, federal officials said, and the original endpoints — the measures of success — were unworkable.

The best outcome would have been a decline in the death rate among patients given remdesivir, but there were only hints that this had occurred.

Despite generally positive results, the researchers caution that the drug is far from ideal.

“Given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” they concluded.

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