Anti-viral drug remdesivir cuts recovery times in coronavirus patients, according to the full results of a trial published Friday night, three weeks after America’s top infectious diseases expert said the study showed the medication has “clear-cut” benefits.
Complete results from the research, which was carried out by US government agency the National Institute of Allergy and Infectious Diseases (NIAID), were published by leading medical periodical the New England Journal of Medicine.
The United States authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering following suit.The study found that remdesivir, injected intravenously daily for 10 days, accelerated the recovery of hospitalized COVID-19 patients compared to a placebo in clinical tests on just over a thousand patients across 10 countries.
On April 29, NIAID director Anthony Fauci, who has become the US government’s trusted face on the coronavirus pandemic, said preliminary evidence indicated remdesivir had a “clear-cut, significant and positive effect in diminishing the time to recovery.”The National Institutes of Health, of which the NIAID is a part, said Friday in a statement online that investigators found “remdesivir was most beneficial for hospitalized patients with severe disease who required supplemental oxygen.”
But the authors of the trial wrote that the drug did not prevent all deaths.”Given high mortality despite the use of remdesivir, it is clear that treatment with an anti-viral drug alone is not likely to be sufficient,” they said.About 7.1 percent of patients given remdesivir in the trial group died within 14 days—compared with 11.9 percent in the placebo group.
However, the result is just below the statistical reliability threshold, meaning it could be down to chance rather than the capability of the drug.
A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12).
As compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).
Conclusions
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705. opens in new tab.)
Source: https://medicalxpress.com
