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 You are here Home Research & Training Medical Research Initiatives ACTIV
 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
 ACTIV
    
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Contact Us Therapeutics Clinical Working Group On this page Charge
		Objectives
		Members
 Charge Prioritize therapeutic agents for testing within an adaptive master protocol strategy that will be jointly designed by the partnership and quickly launched in networks identified by the Clinical Trial Capacity Working Group. Objectives *Check mark indicates completion.* ✓ Agent Prioritization The working group developed a process (see image below) to prioritize clinical agents for rapid testing: An overview of the sources used to identify agents for prioritization in the ACTIV master protocols. The clinical therapeutics fall into four categories (antivirals, immunomodulators, supportive therapies, and neutralizing antibodies). The activities of the prioritizations team is also described as refining the process and criteria, scoring the candidates, and assessing logistical needs.
 Wave 1 Using publicly available sources, approximately 400 candidate agents were identified. Compounds already FDA-approved were the focus to allow for quick repurposing to treat patients. An agent prioritization review committee selected by the working group used an agent triage process to narrow the list to 39 therapeutic candidates. Prioritizing the most promising candidates not already in existing clinical trials was also a focus in order to maximize the number of therapeutic agents in development to ultimately find successful treatments.
	Using a rigorous set of prioritization criteria and a scoring system developed by the working group, the 39 candidates were split into four groups (antivirals, host targeted therapies/immune modulators, and symptomatic/supportive therapies) and scored to determine prioritization for deployment in master protocols.
	Following a final prioritization review, the most promising agents were identified to move into clinical testing. Wave 2 and Beyond The prioritization process was refined, tailored to each therapy class, and applied to additional therapies submitted through the ACTIV Clinical & Preclinical Candidate Compound Survey. In addition, a new agent prioritization sub-team was formed to analyze neutralizing monoclonal and polyclonal antibodies; new prioritization criteria were developed specifically for these neutralizing antibody candidates. An overview of the actual steps in the evaluation process that generates the final list of highly promising therapeutics for testing in the ACTIV master protocols. Each step acts as a gate for the next step and leads to either more detailed consideration or removal from consideration. The types of questions that need to be addressed are shown to be related to current status in human clinical trials, efficacy data in COVID-19 treatment, and other more detailed criteria (for example human delivery data or manufacturing issues). The process that ends in initiation of the therapeutic in an ACTIV master protocol is a reproducible, scientific, data-driven process.
 Based on the results of the first and subsequent waves of agent prioritization, ACTIV clinical trials are now underway. ✓ Clinical and Preclinical Candidates Survey To assist in developing and prioritizing a complete inventory of potential candidates with different approaches to preventing or mitigating COVID-19 infection, ACTIV created a Clinical & Preclinical Candidate Compound Survey in conjunction with the Preclinical Working Group. The survey collected detailed information, such as preclinical and clinical data, on therapeutic candidates. ACTIV is no longer accepting submissions for clinical and preclinical candidate compounds. Master Protocols for Therapeutics The working group has assessed and designed multiple master protocols for ACTIV clinical trials, as well as selected clinical trial networks for these protocols. Using master protocols allows for the standardization of primary endpoints to enable the comparison of trial data, as well as the customization of secondary endpoints appropriate for each trial. ACTIV master protocols have been designed with a portfolio approach in mind and are intended to test all classes of agents in and appropriate patient population and setting, including immunomodulators, anticoagulants, antivirals, and neutralizing monoclonal antibodies. Six master protocols to test the agents selected through the above prioritization process were designed (ACTIV-1, -2, -3, -4, -5, and -6); these are described further on the ACTIV Therapeutics Page. View the clinical trial sites participating in the ACTIV master protocols. Members **Neil Aggarwal, M.D.**
			Chief, Lung Biology and Disease Branch
			National Heart, Lung, and Blood Institute, NIH
 **John Beigel, M.D.**
			Associate Director for Clinical Research, Division of Microbiology and Infectious Diseases
			National Institute of Allergy and Infectious Diseases, NIH
 **Samuel Bozzette, M.D., Ph.D.**
			Chief Medical Officer
			National Center for Advancing Translational Sciences, NIH
 **Jeremy Brown, M.D.**
			Director, Office of Emergency Care Research
			National Institute of Neurological Disorders and Stroke, NIH
 **Tim Buchman, M.D., Ph.D.**
			IPA Senior Advisor, Division of Research, Innovation and Ventures (DRIVe)
			Biomedical Advanced Research and Development Authority, HHS
 **Captain Timothy Burgess, M.D., M.P.H.**
			Director, Infectious Diseases Clinical Research Program
			Uniformed Services University of the Health Sciences
 **Joan Butterton, M.D.**
			Associate Vice President, Clinical Research, Infectious Diseases
			Merck & Co. Inc.
 **Sylva Collins, Ph.D.**
			Director, Office of Biostatistics
			U.S. Food and Drug Administration
 **Judith Currier, M.D.**
			Professor of Medicine
			University of California Los Angeles
			Division of Infectious Diseases
			Chair, AIDS Clinical Trial Group (ACTG)
 **Angelo DeClaro, M.D.**
			Division Director (Acting), Division of Hematologic Malignancies 1
			Center for Drug Evaluation and Research
			U.S. Food and Drug Administration
 **Ruxandra Draghia-Akli, M.D., Ph.D. (Co-Chair)**
			Global Head, Global Public Health R&D
			The Janssen Pharmaceutical Companies of Johnson & Johnson
 **Mark Eisner, M.D., M.P.H.**
			Senior Vice President, Global Head of Immunology, Infectious Disease, and Ophthalmology Clinical Development
			Genentech
 **John Farley, M.D., M.P.H.**
			Director, Office of Infectious Diseases
			Center for Drug Evaluation and Research
			U.S. Food and Drug Administration
 **Joshua Fessel, M.D., Ph.D.**
			Program Director, Lung Vascular Biology Program
			Division of Lung Disease
			National Heart, Lung, and Blood Institute, NIH
 **Carl Garner, M.S., Ph.D.**
			Vice President, Global Regulatory Affairs
			Eli Lilly and Company
 **David Goff, M.D., Ph.D.**
			Director, Division of Cardiovascular Sciences
			National Heart, Lung, and Blood Institute, NIH
 **Keith Gottesdiener, M.D.**
			Retired; past President and Chief Executive Officer
			Rhythm
 **Elizabeth Higgs M.D., M.I.A., DTM&H**
			Global Health Science Advisor for the Division of Clinical Research
			National Institute of Allergy and Infectious Diseases, NIH
 **David Hone, Ph.D.**
			Chief Scientist and Medical Futures Lead
			Defense Threat Reduction Agency
 **W. Keith Hoots, M.D.**
			Director, Blood Diseases and Resources Division
			National Heart, Lung, and Blood Institute, NIH
 **Andrei Kindzelski, M.D., Ph.D.**
			Program Director, Division of Blood Diseases and Resources
			National Heart, Lung, and Blood Institute, NIH
 **Jacqueline Kirchner, Ph.D.**
			Senior Program Officer
			Bill and Melinda Gates Foundation
 **Walter Koroshetz, M.D.**
			Director
			National Institute of Neurological Disorders and Stroke, NIH
 **Lisa LaVange, Ph.D.**
			Professor and Associate Chair, Department of Biostatistics
			University of North Carolina Gillings School of Global Public Health
 **Elliot Levy, M.D.**
			Senior Vice President, Global Development
			Amgen
 **Joanne Lumsden, Ph.D.**
			Senior Scientific Program Manager, Drug Development Partnership Programs
			National Center for Advancing Translational Sciences, NIH
 **Hilary Marston, M.D., M.P.H.**
			Medical Officer and Policy Advisor for Pandemic Preparedness
			National Institute of Allergy and Infectious Diseases, NIH
 **John Mellors, M.D.**
			Distinguished Professor of Medicine, Chief of Division of Infectious Diseases
			University of Pittsburgh School of Medicine
 **Sandeep Menon, M.D., Ph.D.**
			Senior Vice President and Head of Early Clinical Development
			Pfizer
 **Naimish Patel, M.D.**
			Head of Global Development, Immunology and Inflammation Therapeutic Area
			Sanofi Genzyme
 **Amy Patterson, M.D.**
			Deputy Director for Clinical Research and Strategic Initiatives
			National Heart, Lung, and Blood Institute, NIH
 **Amanda Peppercorn, M.D.**
			Senior Medical Director, Infectious Disease
			GlaxoSmithKline
 **Martha Petrovick, Ph.D.**
			Staff Scientist
			Massachusetts Institute of Technology Lincoln Laboratory
 **L. Revell Phillips, Ph.D.**
			Science and Technology Manager
			Joint Science and Technology Office
			Defense Threat Reduction Agency
 **Mike Poole, M.D., F.A.C.P.**
			Therapeutic Accelerator Lead
			Bill & Melinda Gates Foundation
 **Michael Proschan, Ph.D.**
			Mathematical Statistician, Biostatistics Research Branch
			National Institute of Allergy and Infectious Diseases, NIH
 **Sarah Read, M.D. (Co-Chair)**
			Deputy Director, Division of AIDS
			National Institute of Allergy and Infectious Diseases, NIH
 **Lora Reineck, M.D., M.S.**
			Program Director, Acute Lung Injury/Critical Care Program
			Division of Lung Diseases
			National Heart, Lung, and Blood Institute, NIH
 **Ronald Reisler, M.D., M.P.H.**
			Senior Clinical Advisor with DDG (Davis Defense Group)
			under contract to the JPEO-CBRND supporting
			JPM CBRN Medical
 **Yves Rosenberg, M.D., M.P.H.**
			Chief, Atherothrombosis and Coronary Artery Disease Branch
			National Heart, Lung, and Blood Institute, NIH
 **Daniel Rubin, Ph.D.**
			Statistician
			Center for Drug Evaluation and Research
			U.S. Food and Drug Administration
 **Pamela Tenaerts, M.D., M.B.A.**
			Executive Director, Clinical Trial Transformation Initiative
			Duke University Clinical Research Institute
 **Peter Stein, M.D.**
			Director of Office of New Drugs
			Center for Drug Evaluation and Research
			U.S. Food and Drug Administration
 **Christine Sizemore, Ph.D.**
			Director, Division of International Relations
			Fogarty International Center, NIH
 **Peter Wung, M.D.**
			Associate Vice President, Global OMD Lead, Immuno-Inflammation
			Sanofi
 This page last reviewed on November 20, 2023
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