Following China, the U.S. has begun a clinical trial on remdesivir, Gilead’s antiviral candidate for the treatment of the new coronavirus (COVID-19). The trial is the first in America to test an investigational drug to treat COVID-19.
The U.S. National Institutes of Health (NIH) said Tuesday it has started a randomized, controlled trial to evaluate the safety and efficacy of remdesivir in adult COVID-19 patients hospitalized at the University of Nebraska Medical Center (UNMC) in Omaha.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, will be the regulatory sponsor for the trial.
The first participant of the study is a U.S. citizen who was repatriated after being isolated aboard the Japanese cruise ship, Diamond Princess, which docked in Yokohama, Japan. The trial can evaluate additional investigative agents and enroll participants at other sites in the U.S. and other countries, the NIH said.
The NIAID designed the U.S. study considering that clinical trials of remdesivir are also taking place in China and consulting with the World Health Organization.
The participants of the U.S. trial will be COVID-19 confirmed patients who need mechanical respiration, have abnormal chest X-rays, need supplemental oxygen, or have rattling sounds when breathing. Confirmed patients with mild, cold-like symptoms, or no apparent symptoms will not be included in the study.
Researchers will compare outcomes on day 15 between the remdesivir group and the placebo group to evaluate the drug’s effectiveness. Results will be scored on a seven-point scale ranging from fully recovered to death.
According to ClinicalTrials.gov, the U.S. trial will be on 394 people, and the estimated primary completion date is April 1, 2023.
NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci said, “We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes.”
A randomized, placebo-controlled trial is the “gold standard” for determining if an experimental treatment can benefit patients, he added.
An official at Gilead Sciences Korea said Monday that the company was discussing with the Ministry of Food and Drug Safety for local clinical trials on remdesivir.
A member of the Infectious Disease Central Clinical Committee, a group of doctors treating COVID-19 patients, said the committee would announce any updates about clinical trials related to the development of COVID-19 vaccine and treatment through a news conference, after reviewing them thoroughly.