Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

Summary

Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline. Phase 3 Cohort 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.

Timeline

Start

2020-03-18

Primary completion

2020-07-24

Completion

2020-09-02

Outcome

Mixed primary results

registry Negative numbers imply improvement in CRP. NCT04315298 ↗

registry Phase 2: Sarilumab 200mg IV: -0.77 (Standard Error 0.018) Percent Change NCT04315298 ↗

registry Phase 2: Placebo vs Phase 2: Sarilumab 200mg IV; p <0.0001 NCT04315298 ↗

registry Phase 3 Cohort 1: Placebo - Critical vs Phase 3 Cohort 1: Sarilumab 200mg IV - Critical; p = 0.3707 NCT04315298 ↗

registry Phase 3 Cohort 1: Placebo - Critical vs Phase 3 Cohort 1: Sarilumab 400mg IV - Critical; p = 0.3261 NCT04315298 ↗

registry Phase 3 Cohort 2: Placebo vs Phase 3 Cohort 2: Sarilumab 800mg IV; p = 0.7328 NCT04315298 ↗

Publications

• Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7.
• Sivapalasingam S, Lederer DJ, Bhore R, Hajizadeh N, Criner G, Hosain R, Mahmood A, Giannelou A, Somersan-Karakaya S, O'Brien MP, Boyapati A, Parrino J, Musser BJ, Labriola-Tompkins E, Ramesh D, Purcell LA, Gulabani D, Kampman W, Waldron A, Ng Gong M, Saggar S, Sperber SJ, Menon V, Stein DK, Sobieszczyk ME, Park W, Aberg JA, Brown SM, Kosmicki JA, Horowitz JE, Ferreira MA, Baras A, Kowal B, Thomas DiCioccio A, Akinlade B, Nivens MC, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM. Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial. Clin Infect Dis. 2022 Aug 24;75(1):e380-e388. doi: 10.1093/cid/ciac153.
• Boyapati A, Wipperman MF, Ehmann PJ, Hamon S, Lederer DJ, Waldron A, Flanagan JJ, Karayusuf E, Bhore R, Nivens MC, Hamilton JD, Sumner G, Sivapalasingam S. Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial. J Infect Dis. 2021 Dec 1;224(11):1830-1838. doi: 10.1093/infdis/jiab445.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sarilumab	Monoclonal antibody	200 mg	Intravenous
Subject	Sarilumab	Monoclonal antibody	400 mg	Intravenous
Subject	Sarilumab	Monoclonal antibody	800 mg	Intravenous

Indications