A University of Chicago hospital participating in a study of the antiviral medication said it is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, according to medical news website statnews.com.
Gilead, in an emailed statement, said, “The totality of the data need to be analysed in order to draw any conclusions from the trial.”
UChicago Medicine, also, in an email, said, “Partial data from an ongoing clinical trial is, by definition, incomplete, and should never be used to draw conclusions.”
The university said information from an internal forum for research colleagues concerning work in progress was released without authorisation.
Gilead expects results from its Phase-three study in patients with severe COVID-19 at the end of this month, and additional data from other studies to become available in May.
The University of Chicago is one of 152 locations participating in Gilead’s trial involving severe COVID-19 patients, which is “single arm,” meaning it does not measure the drug against a matched group of patients treated with a placebo. A trial of patients with moderate COVID-19 symptoms has 169 study locations.
There are currently no approved treatments for COVID-19, the highly contagious respiratory illness caused by the novel coronavirus that has infected over two million people worldwide.
STAT reported that UChicago Medicine recruited 113 people with severe COVID-19 into Gilead’s trial. It said most of them have been discharged and two patients died.
The “anecdotal data … looks promising on the surface and continues to support some potential for the drug to be active in certain COVID-19 patients,” RBC Capital Markets analyst Brian Abrahams said in a research note. “Nonetheless, there are major limitations to contextualising and interpreting this data.”
Interest in Gilead’s drug amid the ongoing coronavirus pandemic has been high. The New England Journal of Medicine last week published an analysis showing that two-thirds of a small group of severely ill COVID-19 patients saw their condition improve after treatment with remdesivir.
The paper’s author called the findings “hopeful,” but cautioned it is difficult to interpret the results since they do not include comparison to a control group, the patient numbers were small, the details being disclosed were limited, and the follow-up time was relatively short.
The US National Institute of Allergy and Infectious Disease in February began an 800-patient trial that randomly assigns patients to treatment with either remdesivir or a placebo. Those results are not expected until after Gilead’s trial reads out.
Reporting by Ankur Banerjee in Bengaluru and Deena Beasley in Los Angeles; Editing by Lincoln Feast