Hospitalized patients sick with the coronavirus are undergoing the first clinical trial in the U.S. to test an experimental treatment for COVID-19 at the University of Nebraska Medical Center in Omaha, the National Institutes of Health announced Tuesday.
The trial will test antiviral remdesivir, the same drug that was previously tested in patients with Ebola and that has shown promise for treating Middle East respiratory syndrome, another type of coronavirus, in animal studies.
The first trial participant is an American volunteer who was quarantined on the Diamond Princess Cruise ship docked in Yokohama, Japan and flown back to the U.S.
The NIH says the trial is subject to change to evaluate more investigative treatments and to enroll participants from other parts of the U.S. and the globe.
Currently, there are no therapeutics approved by the Food and Drug Administration to treat people with COVID-19, the official name of the coronavirus, which has sickened more than 80,000 and killed about 2,700 worldwide, with recent spikes in South Korea, Italy and Iran.
U.S. health officials have reported 53 cases of the coronavirus, which includes 14 confirmed cases in the states and 39 cases among repatriated citizens, including those previously trapped on the Diamond Princess cruise ship.
Clinical trials of remdesivir, developed by Gilead Sciences, are also underway in China.
“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,” said Dr. Anthony Fauci, NIAID director and U.S. Coronavirus Task Force member. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
Trial participants must have lab-confirmed coronavirus infection and exhibit respiratory issues, which can include rattling sounds when breathing, a need for supplemental oxygen or mechanical ventilation or abnormal chest X-rays.
Those with mild, cold-like symptoms or who aren’t experiencing symptoms will not be included in the study.
Study participants will be randomly assigned to receive the investigational antiviral drug or a placebo and will be monitored throughout the trial.
Dr. Andre Kalil, an infectious diseases physician at Nebraska Medicine, is leading the trial at UNMC.
“We thank the individuals for their participation in this trial, and we are pleased that the NIH has chosen UNMC/Nebraska Medicine as the site for this important work,” Dr. Kalil said. “Our expertise in treating highly infectious disease — as well as our capacity to conduct leading-edge clinical trials — will ensure that this trial is carried out in the most effective manner possible.”
Thirteen people repatriated by the U.S. State Department from the Diamond Princess cruise ship were transported to the National Quarantine Unit located on UNMC’s campus earlier this month.
Since their repatriation, the Centers for Disease Control and Prevention reported that 11 people in the UNMC unit tested positive for the coronavirus. The quarantine unit has a 20-bed capacity and is located nearby the Nebraska Biocontainment Unit.
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