Remdesivir is an investigational antiviral drug being developed by Gilead Sciences for the treatment of Covid-19 and Ebola virus infection.

The drug is currently not approved. The US Food and Drug Administration (FDA) reviewed the investigational new drug (IND) application filed by the company for remdesivir to treat Covid-19 and granted investigational new drug authorisation to study the drug in February 2020.

Gilead is working with government and non-government organisations and local regulatory agencies for providing remdesivir for compassionate use in eligible patients with Covid-19.

Clinical studies on Remdesivir for Covid-19 treatment

Gilead will initiate two Phase III, randomised, open-label, multi-centre clinical studies for the evaluation of safety and efficacy of remdesivir in patients with Covid-19 in March 2020. Approximately 1,000 infected individuals will be enrolled in the studies globally.

The patients will be intravenously administered with remdesivir, and the durations for two doses will be studied. Clinical improvement will be the main target of the study.

In one study, approximately 400 severe Covid-19 patients will be randomised to receive remdesivir for either five or ten days. In another study, 600 moderate Covid-19 patients will be randomised to receive remdesivir for five or ten days or standard-of-care alone.

The studies will be an extension to a few ongoing clinical studies on remdesivir. Two clinical studies led by the China-Japan Friendship Hospital are being conducted at multiple sites in the Hubei Province in China.

Remdesivir is being evaluated in Covid-19 patients who showed severe clinical symptoms such as the need for supplemental oxygen. In another study, the drug is being tested in those hospitalised patients who are not showing significant clinical manifestations. Study results are expected this month.

The National Institute of Allergy and Infectious Diseases (NIAID), US initiated the first randomised, controlled clinical trial in hospitalised adult patients with Covid-19 to determine the safety and efficacy of remdesivir at the University of Nebraska Medical Center (UNMC) in Omaha, US, in February 2020.

Clinical studies on Remdesivir for Ebola virus infection

Remdesivir is currently in the phase II stage of the clinical development for the potential treatment of Ebola virus infection.

The drug is being studied in combination with Mapp BioPharmaceutical’s ZMapp^™, Regeneron’s REGN-EB3 and NIH’s mAb114 in a multi-centre, multi-outbreak, randomised, controlled safety and efficacy clinical study, enrolling 1,500 participants.

Remdesivir is being developed by Gilead Sciences. Credit: NIAID RML.