Sarilumab for Patients With Moderate COVID-19 Disease

Summary

Objectives: To determine whether blockade of IL-6R is beneficial in patients with COVID-19 infection of moderate severity. Research Design: Randomized, controlled trial. Two-arm trial comparing standard care alone to standard care with addition of sarilumab (anti-IL6R). The trial will use a randomized play-the-winner design, in which randomization becomes weighted toward the arm that was more effective in previous subjects in the trial. Methodology Hospitalized patients meeting clinical criteria for moderate disease and testing positive for coronavirus infection. Interventions: sarilumab, 400 mg subcutaneous injection. Standard care is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir or hydroxychloroquine, among others. Up to 120 patients, primary outcome intubation or death within 14 days. All data will be extracted remotely from the electronic health record (EHR). Clinical Implications: The study has potential to establish IL-6R blockade, delivered subcutaneously, as standard of care in reducing progression to critical illness in patients with moderate COVID-19 disease.

Timeline

Start

2020-04-10

Primary completion

2021-08-02

Completion

2021-08-02

Publications

• Background Woods P, Flynn M, Monach P, Visnaw K, Schiller S, Holmberg E, Leatherman S, Ferguson R, Branch-Elliman W. Implementation of documented and written informed consent for clinical trials of communicable diseases: Lessons learned, barriers, solutions, future directions identified during the conduct of a COVID-19 clinical trial. Contemp Clin Trials Commun. 2021 Sep;23:100804. doi: 10.1016/j.conctc.2021.100804. Epub 2021 Jun 26.
• Background Dassum SR, Ferguson R, Woods P, Flynn M, Visnaw K, Holmberg E, Schiller S, Shannon C, Brophy M, Monach P, Leatherman S, Branch-Elliman W; VISN-1 Clinical Trials Network COVID-19 Investigators. Patient- reported reasons for non-participation in a COVID-19 therapeutics clinical trial: Findings from a multi-center investigation. Contemp Clin Trials. 2023 Mar;126:107082. doi: 10.1016/j.cct.2023.107082. Epub 2023 Jan 9.
• Background Dhond R, Acher R, Leatherman S, Page S, Sanford R, Elbers D, Meng F, Ferguson R, Brophy MT, Do NV. Rapid implementation of a modular clinical trial informatics solution for COVID-19 research. Inform Med Unlocked. 2021;27:100788. doi: 10.1016/j.imu.2021.100788. Epub 2021 Nov 12.
• Background Branch-Elliman W, Lehmann LS, Boden WE, Ferguson R, Monach P. Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age? Contemp Clin Trials Commun. 2020 Jul 17;19:100614. doi: 10.1016/j.conctc.2020.100614. eCollection 2020 Sep.
• Background Branch-Elliman W, Monach PA. Not What Anyone Signed up for: Unnecessary and Insurmountable Barriers Encountered in Conducting Clinical Trials in COVID-19. Narrat Inq Bioeth. 2021;11(1):8-15. doi: 10.1353/nib.2021.0003. No abstract available.
• Results Branch-Elliman W, Ferguson R, Doros G, Woods P, Leatherman S, Strymish J, Datta R, Goswami R, Jankowich MD, Shah NR, Taylor TH, Page ST, Schiller SJ, Shannon C, Hau C, Flynn M, Holmberg E, Visnaw K, Dhond R, Brophy M, Monach PA. Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial. PLoS One. 2022 Feb 25;17(2):e0263591. doi: 10.1371/journal.pone.0263591. eCollection 2022.

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