The goal of ACTIV is to develop a research strategy for prioritizing and speeding development of the most promising COVID-19 vaccines and treatments.
The Therapeutics Clinical Working Group is focused on:
- Establishing a steering committee with relevant expertise to set criteria for and rank potential candidates submitted by industry partners for testing
- Developing a complete inventory of potential candidates with different mechanisms of action and acceptable safety profiles
- Designing, launching and openly sharing master protocols with agreed-upon endpoints, sampling and analysis for evaluating candidates
- Using a single control arm to enhance trial efficiency
Clinical Trials for...
- Adult patients who are not hospitalized
- Adults who have been exposed to COVID-19 but have not developed the disease
- Adult hospitalized patients
- And more...
Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. Connors JM, Brooks MM, Sciurba FC, Krishnan JA, Bledsoe JR, Kindzelski A, Baucom AL, Kirwan BA, Eng H, Martin D, Zaharris E, Everett B, Castro L, Shapiro NL, Lin JY, Hou PC, Pepine CJ, Handberg E, Haight DO, Wilson JW, Majercik S, Fu Z, Zhong Y, Venugopal V, Beach S, Wisniewski S, Ridker PM; ACTIV-4B Investigators.JAMA. 2021 Nov 2;326(17):1703-1712. doi: 10.1001/jama.2021.17272.PMID: 34633405
Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3). Murray DD, Babiker AG, Baker JV, Barkauskas CE, Brown SM, Chang CC, Davey VJ, Gelijns AC, Ginde AA, Grund B, Higgs E, Hudson F, Kan VL, Lane HC, Murray TA, Paredes R, Parmar MK, Pett S, Phillips AN, Polizzotto MN, Reilly C, Sandkovsky U, Sharma S, Teitelbaum M, Thompson BT, Young BE, Neaton JD, Lundgren JD.Clin Trials. 2021 Oct 10:17407745211049829. doi: 10.1177/17407745211049829. Online ahead of print.PMID: 34632800
Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy. Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes M, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ; ACTIV-2/A5401 Study Team.medRxiv. 2021 Sep 15:2021.09.03.21263105. doi: 10.1101/2021.09.03.21263105. Preprint.PMID: 34545376
Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines-Selecting Compounds for Clinical Evaluation in Coronavirus Disease 2019 Clinical Trials. Buchman TG, Draghia-Akli R, Adam SJ, Aggarwal NR, Fessel JP, Higgs ES, Menetski JP, Read SW, Hughes EA; Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) Therapeutics Clinical Working Group.Crit Care Med. 2021 Nov 1;49(11):1963-1973. doi: 10.1097/CCM.0000000000005295.PMID: 34495876