Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Phase 3 Completed 515 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depending on the results of their evaluation.

Timeline

Start: 2020-11-24
Primary completion: 2021-08-03
Completion: 2021-08-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Lanadelumab + Standard of Care vs Lanadelumab Placebo Control; p = 0.6672; Hazard Ratio (HR) 1.17 (95% CI 0.59 to 2.35) NCT04590586 ↗

registry analysis (superiority test); Apremilast + Standard of Care vs Apremilast Placebo Control; p = 0.8779; Hazard Ratio (HR) 0.97 (95% CI 0.77 to 1.24) NCT04590586 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	30 mg	Oral
Subject	Lanadelumab	Monoclonal antibody	300 mg	Intravenous
Subject	Zilucoplan	Peptide	32.4 mg	Subcutaneous