The first US clinical trial to assess the efficacy and safety of an investigational broad-spectrum antiviral agent, remdesivir (Gilead Sciences, Inc.), for the treatment of coronavirus disease 2019 (COVID-19) has been initiated at the University of Nebraska Medical Center (UNMC) in Omaha, Nebraska. The trial is being sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
The double-blinded, placebo-controlled study is enrolling patients with laboratory-confirmed SARS-CoV-2 infection with evidence of lung involvement (ie, rales plus a need for supplemental oxygen or abnormal chest X-rays, or the need for mechanical ventilation); those with mild symptoms of the infection will be excluded from the study. Patients will be randomly assigned to receive up to 10 days of treatment with remdesivir (200mg administered intravenously on day 1, followed by 100mg daily during hospitalization) or placebo. Clinical benefit will be assessed on day 15 in both groups and outcomes will be evaluated using a 7-point scale ranging from full recovery to death.
The first participant in the trial is an American who volunteered after being repatriated and quarantined on the Diamond Princess cruise ship in Japan.
In addition, Gilead will initiate two phase 3 trials to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19, following a rapid review and acceptance by the Food and Drug Administration (FDA) of the investigational new drug filing for the novel antiviral. Remdesivir, a nucleotide analog, has been observed in animal models to have broad-spectrum antiviral activity against multiple emerging viral pathogens including Ebola, Marburg, MERS (Middle East Respiratory Syndrome) and SARS (Severe Acute Respiratory Syndrome).
Beginning in March, the studies will enroll approximately 1000 patients in medical centers primarily in Asian countries and in other countries with high numbers of cases. The studies will evaluate both a 5-day and 10-day dosing regimen in patients with moderate to severe clinical manifestations of COVID-19.
Since first being detected in China in December 2019, COVID-19 has been confirmed to be present in over 40 other countries and territories, including the US. Additionally, the disease has caused just over 2600 deaths worldwide, with the large majority being in China. According to the Centers for Disease Control and Prevention (CDC), there have been 15 confirmed cases of COVID-19 in the US and 43 additional cases among persons repatriated to the US as of February 26. The latest case involves a person in California who reportedly did not have relevant travel history or exposure to another known patient with COVID-19, suggesting the possibility of community spread.
For more information visit cdc.gov.