The National Institute of Allergy and Infectious Diseases (NIAID) has begun a clinical trial of experimental drug remdesivir in Nebraska, to see its potential abilities to treat the novel coronavirus, COVID-19.
“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, a member of the U.S. Coronavirus Task Force, said. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
Testing will begin with Americans originally quarantined on the Diamond Princess cruise ship in Japan, who have since been transported to the National Quarantine Unite at the University of Nebraska Medical Center/Nebraska Medicine campus. Since their repatriation, 11 people in the UNMC unit have been confirmed carriers of the viral infection, which has impacted more than 80,000 people worldwide and appears to be picking up speed outside of China.
This will mark the first clinical trial in the United States to assess treatment for COVID-19. The study can also be adapted to evaluate further investigative treatments and enroll participants at other sites worldwide. Clinical trials of the treatment are already ongoing in China.
Gilead Sciences Inc. developed Remdesivir as an investigational, broad-spectrum antiviral treatment. It has been previously tested for use on Ebola and on animal models for treating COVID-19’s fellow coronaviruses, SERS and MERS.
Testing will proceed double-blind, with neither trial investigators nor participants knowing who is receiving remdesivir or a placebo. Those who get the remdesivir will receive 200 mg on the first day and another 100 mg for each day of their hospitalization, up to a maximum of 10 days. All results will be monitored by an independent data and safety monitoring board. The trial is being led by Dr. Andre Kalil, a professor of internal medicine at UNMC and an infectious diseases physician at Nebraska Medicine.
At this time, there remains no therapeutics approved by the Food and Drug Administration to treat COVID-19 patients.