NIAID ACTIV-2 trial begins Phase 2/3 testing on four COVID-19 therapeutics

Another four COVID-19 therapeutics for those with mild to moderate symptoms moved further up the pipeline this week, with the announcement of enrollment for Phase 2/3 testing in the National Institute of Allergy and Infectious Diseases (NIAID) ACTIV-2 trial.

ACTIV, or the Accelerating COVID-19 Therapeutic Interventions and Vaccines program, was designed to coordinate research and encourage the development of promising COVID-19 treatments and vaccines. ACTIV-2 will involve randomized, placebo-controlled studies of Synairgen’s SNG001 inhalable beta interferon, a monoclonal antibody combination from AstraZeneca known as AZD7442 and Camostat mesilate, an oral serine protease inhibitor created by Sagent Pharmaceuticals.

While the study of SNG001 enrolled its first volunteer last week, the other agents should begin enrollments soon. Any that show promise through sufficient safety and reduction of COVID-19 symptoms over the course of 28 days following administration will be moved to a phase three study to gather data from a larger pool of volunteers immediately. Up to 220 volunteers can be enrolled in the phase two studies, but enrollment size for phase three studies can vary.

The therapeutics will be compared against a shared group of placebo recipients. Participants must have tested positive for SARS-CoV-2 — the virus that causes COVID-19 — within 10 days and started experiencing symptoms within eight days of enrollment. Beyond safety and efficacy, a side goal will be to determine if any of these agents can reduce the amount of SARS-CoV-2 detectable in the nasopharynx.

Led by the NIAID-funded AIDS Clinical Trials Group, the study will also be overseen by an independent data and safety monitoring board.

Chris Galford

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