OMAHA, Neb. — The University of Nebraska Medical Center has begun the first clinical trial in the United States of an experimental treatment for the new coronavirus.
The first participant to enroll in the trial is an American who was brought to the UNMC campus after being evacuated from the Diamond Princess cruise ship off the coast of Japan. The person volunteered to participate.
He or she is among 14 people from the ship who are under quarantine at UNMC — 12 in the National Quarantine Unit and two in the separate Nebraska Biocontainment Unit.
The first 13 arrived in Omaha on Feb. 17. The 14th landed Monday evening after being transferred from an Air Force installation near San Antonio, Texas.
Clinical trial participants will be cared for in the biocontainment unit.
The trial is being sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The study, according to the agency, can be adapted to evaluate other treatments and to enroll participants at other sites in the U.S. and worldwide.
Clinical trials of the drug, an antiviral called remdesivir, also are ongoing in China, the center of the outbreak of the novel coronavirus.
The U.S. Food and Drug Administration has not approved any specific treatments for people with COVID-19, the disease caused by the coronavirus.
"We urgently need a safe and effective treatment for COVID-19," said Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.
The federal Centers for Disease Control and Prevention said on its website Tuesday that more cases of COVID-19 are likely to be identified in the coming days, including more cases in the United States. It’s also likely that person-to-person spread will continue to occur, including in the United States.
Widespread transmission of COVID-19 in the U.S., the CDC said, would translate into large numbers of people needing medical care at the same time. Schools, childcare centers, workplaces and other places for mass gatherings may experience more absenteeism. Public health and health care systems may become overloaded, with elevated rates of hospitalizations and deaths.
Fauci noted the antiviral drug has been administered to some patients with the condition. But researchers do not have solid data to indicate it can improve patient outcomes. "A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients," he said.
The drug previously has been tested in humans with Ebola virus disease and has shown promise in animals for treating Middle East respiratory syndrome, or MERS, and severe acute respiratory syndrome, or SARS. MERS and SARS are caused by other coronaviruses.
Dr. Andre Kalil, an infectious diseases physician at Nebraska Medicine and a UNMC professor, is leading the trial at UNMC.
Kalil helped design and launch a trial of a different drug for Ebola virus disease during the waning days of the 2014 outbreak in Africa. Researchers found the experimental drug was safe and showed promise but the study enrolled too few patients to determine whether it was a better treatment than standard care alone.
At the time, however, Kalil said the researchers learned important lessons that would carry into the future. They demonstrated that they could conduct a clinical trial during the middle of an outbreak and try to find the best treatment for patients. The work, he said, left them better prepared for future infectious disease outbreaks.
Participants in an NIH-sponsored trial must have a laboratory-confirmed infection with the new coronavirus 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 study, the NIH said.
Eligible study participants will be randomly assigned to receive the experimental drug or a placebo. The study is double-blind, meaning researchers and participants won't know who is receiving the drug or the placebo.
Either the drug or the placebo will be administered for the duration of hospitalization, for up to 10 days total.
Clinicians will monitor participants and assign them daily scores based on a scale that considers such factors as temperature, blood pressure and use of supplemental oxygen.
Participants also will be asked to provide blood samples and nose and throat swabs about every two days. Researchers will test these specimens for the coronavirus.
Initially, researchers will compare the outcomes of participants in both groups on day 15 to see whether those receiving the drug saw increased clinical benefits compared with those receiving the placebo.