Researchers in the United States started a clinical trial of the Gilead Sciences drug remdesivir to evaluate it as a possible treatment for the disease caused by the new coronavirus.
The randomized, controlled trial is meant to evaluate the safety and efficacy of the drug in adults diagnosed with the respiratory disease COVID-19.
The trial, which is underway at the University of Nebraska Medical Center in Omaha, Nebraska, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)—part of the National Institutes of Health—and includes an American who was flown to the United States from quarantine on the Diamond Princess cruise ship in Japan. The study will be conducted at up to 50 sites globally, according to a filing.
Testing will only include volunteers who have laboratory-confirmed novel coronavirus infections. Participants also need evidence of lung involvement, such as rattling sounds when breathing, or abnormal chest X-rays, or illness so severe that they require mechanical ventilation.
People who have only mild symptoms or who are showing no symptoms won’t be included.
Volunteers will either receive remdesivir—200 milligrams intravenously on the first day and another 100 milligrams per day up to 10 days total—or a placebo. The patients will be monitored by clinicians, and on day 15, participants in the groups will be compared.
The medical center and NIAID said a seven-point scale of clinical outcomes will be reevaluated after reviewing data from the first 100 participants. The filing says the estimated enrollment is 394 participants, with an estimated completion date of April 1.
The trial will be double-blind, meaning that neither participants nor trial investigators will know who is receiving the drug.
“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,” NIAID Director Anthony Fauci said in a statement. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
At a press conference later Tuesday, Fauci said that if a therapy is proven as effective in treating the new disease “it could be a game-changer, because we could then do something from the standpoint of intervention for those who are sick.”
Remdesivir is already being tested in clinical trials in China. Results from those trials are expected in April, a Gilead spokesman told The Epoch Times in an email. The drug received an endorsement from World Health Organization expert Bruce Aylward on Feb. 24.
There are no vaccines for COVID-19 and no proven treatments for the disease, a top American health official said Feb. 25. Dr. Nancy Messonnier, the head of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases, warned during a media briefing that people in the United States should start preparing for community spread of the disease.
Remdesivir was used in the treatment of the first American patient with the virus, according to a case study published in the New England Journal of Medicine. The patient’s condition improved a day after receiving the drug intravenously. Researchers said that randomized controlled trials are needed “to determine the safety and efficacy of remdesivir and any other investigational agents for treatment of patients with 2019-nCoV infection.”
There are 53 confirmed COVID-19 cases in the United States. Case counts in other countries have spiked in recent days, including Italy, Iran, and South Korea.