The randomized controlled trial will assess the activity of the antiviral remdesivir among hospitalized adults at the University of Nebraska Medical Center.
The first clinical trial evaluating experimental treatments for the novel coronavirus (COVID-19) has launched in the United States. The randomized controlled trial will assess the activity of the antiviral remdesivir among hospitalized adults at the University of Nebraska Medical Center (UNMC).
Currently, there are no approved therapies for the treatment of COVID-19, which is caused by the SARS-CoV-2 virus. This trial is being sponsored by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health.
Remdesivir is an investigational broad-spectrum antiviral that is being developed by Gilead Sciences Inc. The agent has been evaluated in humans with Ebola virus disease and has been assessed in animal models for other coronaviruses including Middle East respiratory syndrome and severe acute respiratory syndrome. Gilead Sciences Inc. is also working with health officials in China to evaluate the efficacy of remdesivir among individuals with COVID-19.
To be eligible for the US trial, individuals must have laboratory confirmed infection with SARS-CoV-2 and evidence of lung involvement requiring supplemental oxygen or mechanical ventilation. The study will not enroll individuals with mild symptoms or individuals who are asymptomatic.
All potential patients will undergo a physical exam at baseline. Participants will then be randomized into the investigational group or the placebo group. Individuals enrolled into the investigational group will receive 200mg of remdesivir intravenously on the first day of enrollment and will receive another 100mg each day of hospitalization, for up to 10 days total.
Clinicians will monitor the patients’ temperature, blood pressure, need for supplemental oxygen, and other factors daily to determine daily scores based on a scale of clinical outcomes. Blood and throat swab samples will also be collected approximately every 2 days and tested for SARS-CoV-2.
In the initial stage of investigation, the clinicians will compare participant outcomes on day 15 in both groups to assess if remdesivir treatment has produced any clinical benefit.
An independent data and safety monitoring board will monitor the results of the trial to confirm that patient well-being, study integrity, and safety are all maintained. The study will be halted if there is evidence of a treatment difference between remdesivir and placebo.
The first enrolled patient in the trial is an American citizen who was repatriated following quarantine on the Diamond Princess cruise ship.
On February 17, 2020, 13 individuals were repatriated from the Diamond Princess cruise ship and were transported to the National Quarantine Unit which is located in the Training, Simulation, and Quarantine Center on the UNMC/Nebraska Medicine campus. Of the 13 individuals, 11 have been confirmed to have SARS-CoV-2 infection.
“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,” Andre Kalil, MD, professor of internal medicine at UNMC and an infectious disease physician at Nebraska Medicine, and leader of the trial, said in a statement. “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.”
The press release issued by the National Institutes of Health also notes that the study can be adapted to evaluate additional investigational treatments as well as enroll participants at other treatment sites in the United States and abroad.