The US National Institute of Allergy and Infectious Diseases (NIAID) said Tuesday that it has launched a study to evaluate the safety and efficacy of Gilead Sciences' remdesivir in hospitalised adults diagnosed as having COVID-19. Clinical trials of the investigational broad-spectrum antiviral are also ongoing in China, although they have been slowed due to a lack of eligible patients, with NIAID saying it developed the current study taking those designs into account.
"We urgently need a safe and effective treatment for COVID-19," said NIAID director Anthony Fauci, but while remdesivir "has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes." The news comes a day after Bruce Aylward, an assistant director-general at the World Health Organization, suggested the RNA polymerase inhibitor, which was initially developed for Ebola, appears to be the "one drug right now that we think may have efficacy."
Participants in the NIAID-sponsored trial must have laboratory confirmation that they are infected with SARS-CoV-2, the virus that causes COVID-19, and evidence of lung involvement, including rattling sounds when breathing with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation. Those with confirmed infection who have mild, cold-like symptoms or no apparent symptoms will not be included in the trial. Study participants will be randomly assigned to treatment with either intravenous remdesivir or placebo for up to 10 days.
Investigators will compare patient outcomes on day 15 in both the remdesivir and placebo groups to see if Gilead's drug increased clinical benefit. Outcomes are scored on a seven-point scale ranging from fully recovered to death, with researchers set to re-evaluate the scale after reviewing data from the first 100 study subjects. NIAID noted that the trial can be adapted to evaluate additional investigative treatments and enrol participants in other countries worldwide.
Remdesivir, formerly known as GS-5734, was used to treat the first US patient who came down with COVID-19, according to a case study published last month in the NEJM. Doctors reported at the time that the patient's pneumonia appeared to improve the next day, but they cautioned that one patient's experience is not enough to determine a drug's efficacy.
For related analysis, see ViewPoints: Gilead gains amidst pandemic pandemonium.
To read more Top Story articles, click here.