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Published on: October 29, 2015
Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines-Selecting Compounds for Clinical
Timothy G Buchman1, Ruxandra Draghia-Akli2, Stacey J Adam3
1Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC.
Abstract:
Given the urgent need for coronavirus disease 2019 therapeutics, early in the pandemic the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership rapidly designed a unique therapeutic agent intake and assessment process for candidate treatments of coronavirus disease 2019. These treatments included antivirals, immune modulators, severe acute respiratory syndrome coronavirus 2 neutralizing antibodies, and organ-supportive treatments at both the preclinical and clinical stages of development. The ACTIV Therapeutics-Clinical Working Group Agent Prioritization subgroup established a uniform data collection process required to perform an assessment of any agent type using review criteria that were identified and differentially weighted for each agent class. The ACTIV Therapeutics-Clinical Working Group evaluated over 750 therapeutic agents with potential application for coronavirus disease 2019 and prioritized promising candidates for testing within the master protocols conducted by ACTIV. In addition, promising agents among preclinical candidates were selected by ACTIV to be matched with laboratories that could assist in executing rigorous preclinical studies. Between April 14, 2020, and May 31, 2021, the Agent Prioritization subgroup advanced 20 agents into the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines master protocols and matched 25 agents with laboratories to assist with preclinical testing.
Insights
The Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) partnership developed a process to evaluate over 750 potential COVID-19 treatments. This initiative advanced 20 agents into clinical trials and matched 25 for preclinical studies.
Area of Science:
- Drug Discovery and Development
- Infectious Diseases
- Clinical Research
Background:
- The COVID-19 pandemic created an urgent need for effective therapeutics.
- The Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) partnership was formed to expedite therapeutic development.
- A structured process was required to rapidly assess and prioritize diverse candidate treatments.
Purpose of the Study:
- To describe the establishment and function of the ACTIV Therapeutics-Clinical Working Group Agent Prioritization subgroup.
- To outline the methodology for evaluating and prioritizing potential COVID-19 therapeutic agents.
- To report on the outcomes of the agent prioritization process.
Main Methods:
- Developed a uniform data collection and assessment process for therapeutic agents.
- Established weighted review criteria tailored to different agent classes (antivirals, immune modulators, antibodies, organ support).
- Evaluated over 750 preclinical and clinical candidate agents.
Main Results:
- Prioritized promising candidates for inclusion in ACTIV master protocols.
- Advanced 20 therapeutic agents into ACTIV master protocols between April 2020 and May 2021.
- Matched 25 promising preclinical agents with laboratories for further study.
Conclusions:
- The ACTIV Agent Prioritization subgroup successfully implemented a robust system for evaluating COVID-19 therapeutics.
- The process facilitated the advancement of numerous promising candidates into further preclinical and clinical development.
- This public-private partnership model accelerated the identification of potential treatments for coronavirus disease 2019.
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