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NIH Record - National Institutes of Health

Four Potential Therapeutics for Covid Enter Phase 2/3 Testing

Hundreds of small orange-reddish circles circulate in a cell, attaching to wavy light blue lines.

Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles (red), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick.

Photo: NIAID

Enrollment has begun to test additional investigational drugs in the Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) program. 

ACTIV, sponsored by NIAID, is a public-private partnership that creates a coordinated research strategy to prioritize and speed development of promising Covid-19 treatments and vaccines. The new agents entering the randomized, placebo-controlled study are part of ACTIV-2, an adaptive trial designed to test investigational agents in non-hospitalized adult volunteers experiencing mild to moderate Covid-19 symptoms. 

The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes Covid-19, from entering cells (Sagent Pharmaceuticals). 

The first volunteer enrolled in the SNG001 sub-study on Feb. 10. The other agents under study are expected to begin enrolling participants soon.  

If an investigational agent shows promise by demonstrating safety and reducing Covid-19 symptoms through 28 days following administration, the ACTIV-2 trial then moves to a phase 3 study to gather additional critical data from a larger pool of volunteers. ACTIV-2 trials compare outcomes of multiple interventions with a shared group of placebo recipients. 

To qualify for ACTIV-2, participants must have tested positive for SARS-CoV-2 in the outpatient setting within 10 days and started experiencing symptoms within 8 days of enrolling. To be eligible for the AZD7442 infusion study, participants must be at higher risk—due to age, smoking and/or certain co-morbidities—of progressing to severe Covid-19.

The NIH Record

The NIH Record, founded in 1949, is the biweekly newsletter for employees of the National Institutes of Health.

Published 25 times each year, it comes out on payday Fridays.

Associate Editor: Carla Garnett

Staff Writers:

Eric Bock

Dana Talesnik

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