New Delhi: The experimental drug remdesivir has shown positive results in reducing recovery time among Covid-19 patients as compared to a placebo, a top US physician and government adviser has said.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID), said Wednesday, addressing the media at the White House.
The patients who were administered the drug, he added, were discharged from the hospital in 11 days, on average, as compared to 15 days for a placebo group.
Placebo groups comprise patients who are given inactive “dummy” pills — placebos — to assess, by comparison, the efficacy of a certain drug.
“What it has proven is that a drug can block this virus,” Fauci said, referring to data from a study of more than 1,000 patients across the US and around the world. He said the drug would become part of standard Covid-19 care in the US.
Covid-19 has killed over 2 lakh people worldwide since it was first reported in December 2019, but a cure and vaccination remain elusive. Scientists around the globe are busy trying to come up with a solution to help the world get back on its feet after the shock delivered by the drug.
Talking about the trial, Fauci said preliminary results had shown that the drug led to faster recovery in Covid-19 patients. He said there were indications the drug led to fewer deaths, but added that this part of the analysis is still under review.
The US Food and Drug Administration, the American drug regulatory body, is expected to approve the drug for emergency use in Covid-19 as it had earlier done for antimalarial drug hydroxychloroquine.
The drug, which was developed for Hepatitis C and then tried against Ebola, has not been approved for any disease globally.
What does the study say?
The study reportedly concluded that patients who were given remdesivir recovered in 11 days, while those who received a placebo did so in 15 days.
“While the 31 per cent improvement may not seem like a 100 per cent knockout, it gives a proof of concept that the drug can block the virus,” Fauci said.
The patients who received remdesivir had a mortality of 8 per cent as compared to 11 per cent in the placebo arm, Fauci said, adding that this difference was not statistically significant.
The results of the study, he added, will be published in an international journal soon and be open to peer review.
This study, and another by remdesivir manufacturer Gilead showing similar results, come as another clinical trial detailed in The Lancet, a medical journal, suggested the drug had not shown significant clinical benefits in critically-ill patients.
Results of the trial
Gilead has announced the results of a phase-three trial, which concluded that severe patients with Covid-19 who received a five-day course of the drug showed similar improvement as those who got a 10-day course of the drug.
The study found that the time taken for clinical improvement of symptoms among patients receiving the drug for five days was 10 days, and 11 days for those who received it for 10 days.
However, since both the groups had received the drug, the trial could not prove its effectiveness in comparison to conventional therapy.
The Lancet study
Published on 29 April, the Lancet study said “remdesivir was not associated with statistically significant clinical benefits”.
The study, which involved 237 severe Covid-19 patients, showed that the time taken to recover was similar for patients receiving remdesivir and a placebo — 21 days and 23 days, respectively.
For patients who received the drug within 10 days of showing symptoms, it led to a recovery time of 18 days as compared to 23 days for a placebo. However, the authors said it wasn’t statistically significant.
The trial, which aimed to enrol 453 patients in China, had to be terminated as the Covid-19 pandemic has been controlled in the country and eligible patients could not be found.
The authors said studies with larger sample sizes were needed to investigate the effect of remdesivir.