NIAID's Adaptive COVID-19 Treatment Trial began on Feb. 21 and found that remdesivir was better than a placebo in terms of time of recovery, which is a metric often used in influenza trials. Recovery was defined as being well enough for hospital discharge or return to normal activity level.
Patients who received remdesivir recovered 31% faster, with a median recovery time of 11 days compared to 15 days for those who received the placebo. The mortality rate for the remdesivir group was 8% versus 11.6% for the placebo group, NIAID stated. (NIAID Director Dr. Anthony Fauci cautioned during a press conference on Wednesday that the death rate has not yet reached statistical significance, and the data needs to be further analyzed.)
Sixty-eight sites across the globe participated in the study — 47 in the United States and 21 in countries in Europe and Asia.
Fauci said the remdesivir trial is reminiscent of research conducted 34 years ago when he and others were looking at the human immunodeficiency virus (HIV). They performed the first drug tests with the antiretroviral drug azidothymidine (AZT), which had a modest effect on HIV, and were able to build on it to create more effective drugs, he said. Fauci thinks the same will be true with remdesivir.
Gilead also announced Wednesday the results of two randomized Phase 3 clinical trials for remdesivir, which were conducted in countries with a high prevalence of COVID-19.
In Gilead's first trial, researchers gave five-day and 10-day doses of remdesivir intravenously to 397 hospitalized patients who had pneumonia and reduced oxygen levels but did not require mechanical ventilation. The study sought to determine whether a shorter course of remdesivir would be as effective as a 10-day regimen currently being used in multiple ongoing studies of the drug.
Fifty percent of patients who received treatment showed improvement in 10 days among the five-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both groups were discharged from the hospital by day 14.
Patients who were given remdesivir earlier also had improved outcomes. Participants who received the drug within 10 days of the onset of symptoms fared better than those treated more than 10 days into the disease. By day 14, 62% of patients who treated early in their illness were cleared for hospital discharge compared with 49% of patients who were treated later.
"The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir," Dr. Merdad Parsey, Gilead Sciences' chief medical officer, said in the company statement.
Remdesivir isn't licensed or approved and has not yet been demonstrated to be safe or effective for the treatment of COVID-19, the statement noted. Gilead said it plans to submit the full data for publication in a peer-reviewed journal in coming weeks.
A second trial study is evaluating the safety and effectiveness of five-day and 10-day remdesivir dosing in patients with moderate COVID-19 symptoms. The results from the first 600 patients of this study are expected at the end of May.
Palo Alto resident Monica Yeung-Arima, who was one of the patients in Gilead's first remdesivir trial, said on Wednesday that she is gratified by the trial results. Yeung-Arima was given a five-day treatment of remdesivir starting March 13. She began to recover three days into her treatment.
"I am so glad that I'm one of the guinea pigs. I am getting better every day," Yeung-Arima said in a text message to this news organization.
"I'm so glad that there's positive news on remdesivir and the drug can possibly be used by many patients soon. ... It also can put many people at ease to have a solution, even if it's not a 100% cure," she said.
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