RE: PMWC tomorrow27 Jun 2022 19:37
Talk
Agent Selection and Master Protocols for Evaluation of Candidate COVID-19 Therapeutics and Lessons Learned for Future Pandemics
Working in an unprecedented timeframe, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership rapidly designed a unique therapeutic agent intake and assessment process for multiple types of candidate treatments (preclinical and clinical antivirals, immune modulators, SARS-CoV-2 neutralizing antibodies, and organ supportive) for COVID-19, reviewing over 800 and advancing over 30 agents to trials for testing. ACTIV also developed and launched ten master protocols between April 2020 and August 2021 to allow for the coordinated and efficient evaluation of these over 30 investigational therapeutic agents. The ACTIV master protocols were designed with a portfolio approach to serve multiple patient populations with COVID-19: outpatient mild to moderately ill, inpatient moderately ill, and inpatient critically ill and designed to test the spectrum of the disease pathophysiology. Each protocol, either adaptive or pragmatic, was designed to efficiently select those treatments that provide benefit to patients while rapidly eliminating those that were either not effective or safe. For both the agent prioritization and master protocol development ACTIV has captured lessons learned that may be useful in meeting the challenges of a future pandemic.