Medical news portal Stat on Thursday reported some leaked results of a pair of Phase 3 clinical trials of antiviral medicine "remdesivir," a drug being considered as a potential Covid-19 cure.
Of the 113 coronavirus patients treated with daily infusions of remdesivir at the University of Chicago, most were discharged from the hospital in under a week, and only two died.
But there are some caveats and cautions, according to Diana Brainard, chief of antiviral clinical research at Gilead Sciences – the biotech giant whose drug portfolio includes remdesivir.
"We have to assess whether the drug is working without having a clear picture of what is typical with this disease," she told the New York Times, terming the trial anecdotal and pointing out that it did not include a control group.
The life of this "wonder drug" began in 2009 as a potential treatment for Hepatitis C, but did not meet expectations. It got a second chance during an Ebola outbreak in Congo, where it showed limited effects but proved safe to use on people.
Lab tests, however, suggested it might have potent effects against coronaviruses such as those that cause SARS and MERS.
Gilead began distributing it on a compassionate-use basis on January 25, reports New York Times.
"By March we were getting hundreds of requests a day," Brainard said. "We needed to pivot to a different kind of system – expanded access. Instead of providing the drug to each patient individually, you provide it to individual physicians and they administer it as they see fit."
However, Gilead and its biotech peers have to walk a fine line between offering hope and inflating expectations of patients and their families, and moving with all possible speed as well as utmost caution.
The next step, according to Brainard, is to inspect the data from the trial and other concurrent studies of remdesivir now involving 6,000 participants with severe symptoms.
If the results hold up, the Food and Drug Administration and other regulatory agencies would have to provide approval.
That could take a full year, barring an expedited process. Then production of the drug would need to ramp up quickly – no small feat as remdesivir requires complex manufacturing techniques.