New story in Health from Time: Leaked Data From a Key Remdesivir Study Suggest the Potential Coronavirus Drug Is Not Effective

A summary of a study conducted in China on a potential COVID-19 treatment, remdesivir, was posted on the World Health Organization (WHO) website on Thursday and then removed.

The researchers responsible for the study had not approved its posting; Tarik Jasarevic, a WHO spokesperson told STAT that it was “inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments.”

Remdesivir, an experimental drug originally developed to treat Ebola, is not yet approved for that or any other disease. But studies conducted by remdesivir’s maker, Gilead, have shown that the experimental drug could be effective against coronaviruses like those that cause SARS and MERS. So during the COVID-19 crisis, Chinese researchers contacted the company about using it to treat the sickest patients, and Gilead made the drug available under a compassionate use program, to treat those with no other treatment options.

After Gilead agreed, Chinese doctors launched two formal studies of remdesivir; one in severely ill patients, and another in people with milder disease. Both studies compared the drug to a placebo. But in mid-April, both were suspended when scientists could not enroll the more than 400 patients needed for each trial.

The summary posted temporarily to the WHO’s website involved the trial to treat severe patients. The Chinese researchers noted that remdesivir was “not associated with a difference in time to clinical improvement,” according to STAT, which took a screen shot of the study before it was removed. In addition, according to the documentation briefly published on the WHO site, after a month, there was almost no difference in the fatality rate of patients given remdesivir compared to those who received the placebo.

In a statement responding to the results, Dr. Merdad Parsey, chief medical officer of Gilead Sciences, said “we believe the post included inappropriate characterizations of the study. The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions. As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in the disease.”

Parsey seemingly was referencing recent remdesivir studies involving COVID-19 patients in the U.S., Europe and Canada, which have hinted at more positive results. In one, which involved 53 patients who were treated with remdesivir on a compassionate use basis, 68% of those experiencing severe respiratory symptoms improved after 10 days. In another, involving 125 U.S. patients, most who took the drug improved enough to be discharged from the hospital. However, unlike the Chinese studies, those trials did not compare remdesivir to a placebo.

The studies from China would be the first to provide solid data from gold standard clinical trials that randomly assigned people to remdesivir or placebo. Their results would likely guide decisions about ongoing trials in the U.S. and around the world, including one sponsored by Gilead and another by the National Institutes of Health, seeking to uncover which COVID-19 patients might benefit most from the drug, and when in the course of the disease the drug is most effective. Those studies, however, will take months to complete, regardless of this data leak.

New story in Health from Time: COVID-19 Has Been ‘Apocalyptic’ for Public Transit. Will Congress Offer More Help?

While trying to get to work over the past few months, Brittany Williams, a Seattle home care worker, has often been passed by two or three buses before one stops to let her board. Buses in her area that once carried anywhere from about 50 to 100 passengers have been limited to between 12 and 18 to prevent overcrowding in response to coronavirus, and Williams’ commute, typically a half-hour ride, now takes more than double that time. Other Seattle transit riders have described budgeting as much as an extra hour per trip to account for the reduced capacity, eating into their time at work, school or with family. Even with the ridership limits in place, Williams, 34, doesn’t feel safe on public transit. Some passengers don’t wear face coverings, and bus drivers sometimes ignore capacity limits, she says. On one ride with her seven-year-old son, she decided to get off at a stop far from her home after a driver allowed a crowd of people to board. “It’s very trying. I’ll put...

New story in Health from Time: An At-Home Coronavirus Test May Be On the Way in the U.S.

As cases of COVID-19 continue to climb in the U.S. , there’s a new urgency to make sure there are as many tests as possible to diagnose people who have symptoms that might indicate an infection. Knowing if people are positive is important for guiding their next steps: self-isolation, avoiding contact with others, and, if their symptoms get worse, seeking medical care. To date, access to tests has been spotty at best across the country, and while more kits are now available than even a week ago , most are gene-based assays that take several days for commercial labs to process and produce results. That may change in about two months if the Food and Drug Administration (FDA) gives Emergency Use Authorization to the first blood-based COVID-19 test in the U.S. Scanwell Health, an at-home test company based in California, licensed the rights to a test developed by Chinese company Innovita, which was used extensively at the height of country’s epidemic earlier this year. “The ...

New story in Health from Time: A Montana Care Home Refused Free COVID-19 Tests. Now, Nearly Every Resident Has Coronavirus

(BILLINGS, Mont.) — It was meant to be a last line of defense to protect the most vulnerable as the coronavirus spread across the United States : Montana officials offered free testing in May for staff and residents at assisted living and long-term care facilities. But not all of them followed through, according to state data, including a facility in Billings, Montana’s largest city, that cares for people with dementia and other memory problems. The virus has infected almost every resident and killed eight, accounting for almost a quarter of Montana’s 34 confirmed deaths. Thirty-six employees also have tested positive at the facility where 59 people lived before the deaths began. Read more: ‘It’s Getting Worse.’ Nursing Home Workers Confront Risks in Facilities Devastated by Coronavirus While Montana’s rates of confirmed infections and deaths are much lower than other parts of the country, the outbreak at Canyon Creek Memory Care illustrates that even the most simple an...

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