The antiviral drug remdesivir now undergoing randomized, international phase 3 clinical trials as a cure for COVID-19 was extolled for its capability to block "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)," the virus that causes COVID-19, by Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID).
Dr. Fauci on Wednesday hailed the results of the remdesivir clinical trial conducted by NIAID, calling it "quite good news." He believes remdesivir "will be the standard of care" for COVID-19 moving forward.
Preliminary results from the NIAID trial show patients given remdesivir recovered 31% faster than those given a placebo. These results were praised by Dr. Fauci as "highly significant."
"This is really quite important," said Dr. Fauci at the White House. He compared this result to a moment in 1986 "when we were struggling for drugs for HIV and we had nothing."
He said Remdesivir shortened the period patients experienced symptoms and slightly reduced the mortality rate. He pointed out the mortality rate trended lower for those that took the remdesivir -- 8% compared to 11% -- for those that didn't. Dr. Fauci said the trend isn't yet statistically significant and the results will undergo further analysis.
"What it has proven is that a drug can block this virus," noted Dr. Fauci. He called this finding "very optimistic."
The NIAID phase 3 trial involves more than 1,090 people. The results haven't been peer-reviewed but was submitted to a journal for review, said Dr. Fauci, who had read the results.
Remdesivir, which was developed by Gilead Sciences, Inc., is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens such as Ebola, MERS and SARS.
In vitro testing by Gilead Sciences has demonstrated remdesivir is active against SARS-CoV-2. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. Gilead Sciences said it's aware of positive data emerging from the NIAID study of remdesivir as a treatment for COVID-19.
"We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing," said the company in a statement.
In addition to the NIAID trial, Gilead will soon share additional remdesivir data from its open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease. This study will provide information on whether a shorter, 5-day duration of therapy might have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May.
On Wednesday, Gilead also released preliminary results from its own study, showing improvements in at least 50% of patients treated with a five-day dosage of remdesivir. The clinical trial involved 397 patients with severe cases of COVID-19. The "single-arm study" didn't evaluate remdesivir against a control group of patients that didn't receive the drug.
