The University of Pittsburgh School of Medicine (Pitt) represents one of 25 initiated trial site organizations investigating novel therapies targeting the earlier stages of COVID-19 in a bid to start focusing on early treatment to reduce disease progression. Pitt has teamed with the National Institute of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative—funded via Operation Warp Speed—and its “ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial” inclusive of both Phase 2 and 3 clinical evaluation of multiple promising treatments for early COVID-19 in a single trial. The study team is led by Madhu Choudhary. TrialSite reported that Pitt actually discovered a monoclonal antibody called Ab8, with significant promise targeting COVID-19. Pitt applied to have their novel discovery, Ab8 included in ACTIV-2.
What is ACTIV-2?
A randomized, blinded, controlled adaptive platform, ACTIV-2 introduces flexibility enabling investigators to add promising drugs, or for that matter drugs can be removed. In this way, researchers can more efficiently and expeditiously investigate a variety of novel drugs in comparison against placebo. The first drug under investigation is Lilly’s monoclonal antibody known as LY-CoV555.
In the Phase 2 segment, the investigators and study staff will recruit 110 patients nationwide to receive the LY-Cov555 infusion (again the experimental antibody showing significant promise)—see TrialSite updates. 110 patients will receive a placebo (plus standard of care) and, of course, the study is blinded so the investigators won’t know which patient received which treatment.
As the study moves to Phase 3, study teams will investigate the medication and its efficacy in preventing hospitalization and death in adults infected with SARS-CoV-2, the virus behind COVID-19. Including those that participated in the Phase 2 segment, a total of 1,000 patients will receive the medication.
The study team will repeat this process with multiple medications as they are available, reports Pitt Wire.
Other Pitt Activities Targeting COVID-19
Pitt announced in addition to participation in ACTIV-2 also engagement in the ACTIV-4 program, a trio of NIH-sponsored Phase 3 trials investigating the role of blood thinners in saving human life while improving care.
Additionally, distinguished professor and the Mitchell P. Fink Endowed Chair of Pitt’s Department of Critical Care Medicine, Derek Angus, led a study which appeared in the Journal of the American Medical Association and Informed the World Health Organization’s recommendation to use steroids to treat critically ill COVID-19 patients.
Moreover, TrialSite reported on progress made by Pitt researchers, discovering a tiny antibody component that could potentially help treat COVID-19. In fact that article led to direct interest from accredited investors. Known as Ab8, Pitt already applied for this investigational product’s inclusion in the adaptive ACTIV-2 trial, according to PittWire. A spin-off, Abound Bio, was assigned the intellectual property rights.
The ACTIV-2 program is led by the AIDS Clinical Trials Groups (ACTG), the world’s largest and longest-running HIV clinical trials networks. Pitt joined this network in 1998.
Nationally, ACTIV-2 is led by Davey Smith of the University of California, San Diego; along with Kara W. Chew and Eric S. Daar, both of University of California, Los Angeles (UCLA); and David Alain Wohl of the University of North Carolina (UNC). It is supported by ACTG chair Judith Currier, UCLA, and ACTG co-chair Joseph J. Eron, UNC.
Call to Action: If you are based in the Pittsburgh area and want to learn more, contact [email protected] or check out the ACTIV-2 website. Principal Investigator Choudhary commented, “People living in the Pittsburgh area who have recently been diagnosed with COVID-19 and are not hospitalized have the opportunity to make a huge contribution by participating in this study.”