The National Institutes of Health (NIH) has reported that a clinical trial assessing Gilead Sciences’ remdesivir in hospitalised Covid-19 patients in the US has started.
The randomised controlled trial, which is funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), is being performed at the University of Nebraska Medical Center (UNMC) in Omaha.
This marks the first US study of an investigational drug to treat Covid-19. Clinical studies of remdesivir are already underway in China.
The US trial can be expanded to test other therapies and to enrol patients at other sites in the country, as well as internationally.
Remdesivir is an experimental broad-spectrum antiviral drug that was originally developed to treat Ebola. The drug yielded encouraging results in animal models for the treatment of Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS).
NIAID director Anthony Fauci said: “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.
“A randomised, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
The first participant in the new trial is a US citizen repatriated from the Diamond Princess cruise ship that was quarantined in Yokohama, Japan.
Patients with laboratory-confirmed SARS-CoV-2 infection will be enrolled in the trial. Participants must have an indication of lung involvement, including rattling sounds when breathing, abnormal chest X-rays, or illness that needs mechanical ventilation.
People with confirmed infection but mild symptoms or no symptoms will not be recruited.
Participants will be given 200mg of intravenous remdesivir on the first day of enrolment, followed by 100mg each day during their hospitalisation for up to 10 days.
On day 15, data from the treatment group will be compared to that obtained from the placebo group. Results will be further analysed after obtaining data from the initial 100 participants.