Description of Collaborative Activity: |
The ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates. The ACTIV-1 master protocol tested three promising immune modulator compounds, a class of drugs that help minimize the deleterious effects of an overactive immune response to SARS-CoV-2 infection. This Phase 3 trial enrolled hospitalized adults with moderate to severe COVID-19 disease. The goal of the trial was to evaluate the safety and efficacy of each immune modulator when given as an add-on therapy to standard of care (SOC) at local clinics, which may have included remdesivir (provided as part of the study to all participants), an antiviral approved for treatment of COVID-19. The different treatments were assessed with respect to illness severity, recovery speed, mortality, and hospital resource utilization. The trial is completed, and results on the two immune modulators that showed efficacy are available on medRxiv. |
