Feb 25, 2020: A randomized, controlled clinical trial to evaluate the safety and effectiveness of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
This is the first clinical trial in the United States in order to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.
The first participant in the trial is an American who was
repatriated after being quarantined on the cruise ship Diamond Princess that
docked in Yokohama, Japan and volunteered to participate in the study. The
study can be adapted to evaluate additional investigative therapies and enroll
participants at other sites in the United States and around the world.
The Food and Drug Administration (FDA) has not approved specific therapies for treating people with COVID-19, the disease caused by the newly emerging SARS-CoV-2 virus (formerly known as 2019-nCoV). Infection may cause mild to severe respiratory disease, and symptoms may include fever, cough, and breathing shortness. The World Health Organization (WHO) reported 77,262 confirmed cases of COVID-19 and 2,595 deaths in China as of 24 February, and 2,069 cases of COVID-19 and 23 deaths in 29 other countries.
According to the Centers for Disease Control and Prevention (CDC), there were 14 confirmed cases of COVID-19 reported in the United States, and an estimated 39 cases among people repatriated to the United States.Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.
Remdesivir clinical trials are underway in China, too. In line with the consultations convened by the WHO on the development of a therapeutic trial for patients with COVID-19, NIAID developed the current study taking into account those designs. Participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) requiring additional oxygen or abnormal X-rays in the chest, or mechanical ventilation disease. The study will not include individuals with reported infection who have mild, cold-like symptoms or no apparent symptoms.
Eligible patients will provide informed consent to participate in the trial, in accordance with standard clinical research protocols. On the first day of admission to the study, participants in the investigational therapy group will receive 200 milligrams (mg) of remdesivir intravenously. For the duration of the hospitalization, they will receive another 100 mg each day, for a total of up to 10 days. The placebo group will obtain a solution that resembles remdesivir, which contains only inactive ingredients, at an equal volume.
For more information, visit ClinicalTrials.gov and search identifier NCT04280705. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins
