A clinical trial of remdesivir for COVID-19 patients, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), wasn’t just the first trial of its kind in the U.S. In fact, findings from that trial led directly to two emergency use authorizations (EUAs) from the Food and Drug Administration (FDA) and ultimately to the FDA’s first approval of a COVID-19 therapy without an emergency use qualifier.

Within weeks of the COVID-19 outbreak in Wuhan, China, the Division of Microbiology and Infectious Diseases (DMID) at the NIAID began collaborating with companies to clinically assess existing therapies for treating COVID-19, using networks supported by the National Institutes of Health as well as other sites. 

Remdesivir, an investigational antiviral drug developed by Gilead Sciences Inc., emerged as a promising early therapeutic candidate for COVID-19 based on preliminary studies involving other types of coronaviruses. 

On Feb. 21, 2020 — before the World Health Organization had declared a pandemic — the DMID and NIAID initiated the Adaptive COVID-19 Treatment Trial (ACTT), a randomized, controlled clinical trial to evaluate the safety and efficacy of intravenous remdesivir in hospitalized adults diagnosed with COVID-19. This NIAID-sponsored trial was the first clinical trial in the U.S. to evaluate an experimental treatment for COVID-19.

The Technology Transfer and Intellectual Property Office (TTIPO) at the NIAID worked with the DMID to negotiate a Clinical Trial Agreement (CTA) with Gilead to obtain remdesivir and draft template agreements to expedite expanded testing within the United States and internationally. The creative technology transfer solutions and expeditiously negotiated agreements enabled initiation of the ACTT trial less than two months after identification of the virus responsible for the initial Wuhan outbreak.

The FDA issued an EUA on May 1, 2020, for the emergency use of remdesivir to treat hospitalized patients with severe COVID-19, and on Aug. 28 expanded the EUA by no longer limiting its use to patients with severe disease.

The creative technology transfer solutions and expeditiously negotiated agreements enabled initiation of the ACTT trial less than two months after identification of the virus responsible for the initial Wuhan outbreak. 

On Oct. 22, the FDA approved remdesivir for the treatment of most COVID-19 patients who require hospitalization — the first therapy to receive a non-EUA approval for COVID-19 use.

The ACTT trial has progressed to test remdesivir in combination with other existing therapies. ACTT-2 began on May 8, 2020 to test remdesivir plus Eli Lilly’s anti-inflammatory drug baricitinib. ACTT-3 began on Aug. 5 to assess remdesivir plus Merck’s immunomodulatory drug interferon-beta 1a. For those two trials, the NIAID TTIPO successfully negotiated CTAs with Eli Lilly to obtain baricitinib and with EMD Serono (d.b.a. Merck) to obtain interferon beta-1a.

The NIAID is pursuing testing of potential compounds in combination with remdesivir under the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, and the successful combinations will be further evaluated in larger clinical trials, potentially leading to additional robust and effective therapies for COVID-19.