ACTIV-2: A Study for Outpatients With COVID-19

• ClinicalTrials.gov Identifier: NCT04518410
• Recruitment Status: Active, not recruiting
• First Posted: August 19, 2020
• Last Update Posted: March 9, 2023
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eli Lilly and Company; AIDS Clinical Trials Group; Brii Biosciences Limited; AstraZeneca; Sagent Pharmaceuticals; Synairgen Research Ltd.; Bristol-Myers Squibb; SAb Biotherapeutics, Inc.
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Results Submitted - Quality Control (QC) Review Has Not Concluded

Results information for an applicable clinical trial (ACT) is posted within 30 days of submission even if the submission has not completed the ClinicalTrials.gov Results Quality Control (QC) review process. Results information is submitted to ClinicalTrials.gov by the sponsor or investigator, and National Library of Medicine (NLM) staff assess for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

All versions of ACT results information submissions that have not completed the QC review process are posted on ClinicalTrials.gov (since January 2020). After the QC review process is completed, the results information is posted without QC review comments and previous versions are archived.

• Recruitment Status: Active, not recruiting
• Actual Primary Completion Date: April 7, 2022
• Estimated Study Completion Date: June 22, 2023

Submission Cycle	Results Submitted to ClinicalTrials.gov	Results Returned after Quality Control Review
1	April 7, 2023	May 2, 2023 Submission with QC Comments
2	May 26, 2023

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes MD, 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. Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial. Nat Microbiol. 2022 Nov;7(11):1906-1917. doi: 10.1038/s41564-022-01254-1. Epub 2022 Oct 26.

Boucau J, Chew KW, Choudhary MC, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA 2nd, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM; POSITIVES study team; Li JZ, Barczak AK; ACTIV-2/A5401 Study Team. Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. Cell Rep Med. 2022 Jul 19;3(7):100678. doi: 10.1016/j.xcrm.2022.100678. Epub 2022 Jun 20.

Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs R, Ritz J, Giganti M, Javan AC, Li Y, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM. Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19. medRxiv. 2021 Dec 21:2021.12.17.21268009. doi: 10.1101/2021.12.17.21268009. Preprint.

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.