Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)

Phase 2 Completed 124 enrolled CSL Behring

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC) treatment, in patients with Coronavirus disease 2019 (COVID 19)

Timeline

Start: 2020-07-01
Primary completion: 2021-01-12
Completion: 2021-01-12

Outcome

Missed primary endpoint

paper No difference in incidence of tracheal intubation or death (p = 0.274) PMID 37000214 ↗

release “whilst garadacimab was found to be safe for these critically ill patients, the treatment was not effective in reducing severe complications of COVID-19” csl.com ↗

Publications

Papi A, Stapleton RD, Shore PM, Bica MA, Chen Y, Larbig M, Welte T. Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19. Lung. 2023 Apr;201(2):159-170. doi: 10.1007/s00408-023-00615-9. Epub 2023 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSL312	Monoclonal antibody	700 mg	Intravenous