Will the FDA authorise the use of remdesivir to treat COVID-19 by the end of 2020?

Cross-posted on Metaculus: Pandemics.

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity. It is not approved anywhere globally for any use.

According to its producer, Gilead Sciences:

Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.

From the National Institutes of Health:

A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the 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 National Institutes of Health. This is the first clinical trial in the United States to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.

“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,” said NIAID Director and U.S. Coronavirus Task Force member Anthony S. Fauci, M.D. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Will the FDA authorise the use of remdesivir to treat COVID-19 by the end of 2020?

This question resolves positively if, before the end of 2020, the FDA reports that remdesivir has been officially authorised for use in humans as a medical countermeasure to COVID-19. This must permit remdesivir to be administered to some members of the public in at least some circumstances that are not clinical trials. Usage under Emergency Use Authorization is sufficient for positive resolution.

Categories: Novel Coronavirus (Covid-19), Biological Sciences – Medicine

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