For weeks, the world has been eagerly awaiting clinical trial results for one experimental drug, remdesivir, to treat Covid-19. On some days, the entire stock market has moved up and down based on limited amounts of data about the therapy from Gilead Sciences. The signals, so far, have been contradictory. An early peek at one study, based on data from patients treated at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group. A fuller picture on remdesivir is expected any day now. Gilead has said that it will release data from one of its U.S. trials — the one from which the Chicago results were disclosed — by the end of this week.
Regeneron, Sanofi Amend Covid-19 Drug Clinical Trial Protocol
Tarrytown, New York-based Regeneron Pharmaceuticals and Paris-based Sanofi said Monday that they would amend the 600-patient Phase III portion of their Phase II/III study of Kevzara (sarilumab) so that it would only enroll patients critically ill with Covid-19 and exclude severely ill patients. The decision was based on a recommendation following a review of available Phase II and Phase III data by the trial’s independent data monitoring committee, showing that while there was a positive trend in favor of the drug among critically ill patients, the trend among severely ill patients was negative. The Phase III portion is also being amended to randomized patients only to Kevzara at 400mg or placebo, while discontinuing the 200mg dose.
Doctors are Testing Whether Estrogen Could Help Men Fight COVID-19
Since the COVID-19 pandemic first emerged in China, men around the world have been more likely to require intensive medical care or die from the disease than women, according to the Times report. For instance, men make up about 75% of the COVID-19 patients in intensive care or on ventilators at Cedars-Sinai Medical Center in Los Angeles, Dr. Sara Ghandehari, a pulmonologist and intensive care physician, told the Times. And as of early April, infected men in New York City were dying at about twice the rate of infected women, according to NPR.