A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)

Phase 2 Completed 227 enrolled Kinevant Sciences GmbH Roivant Sciences, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.

Timeline

Start: 2020-04-15
Primary completion: 2020-12-01
Completion: 2021-04-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Gimsilumab vs Placebo; p = 0.1885; Risk Difference (RD) 0.05 (95% CI -0.06 to 0.17) NCT04351243 ↗

paper Gimsilumab did not improve mortality or other key clinical outcomes in patients with COVID-19 pneumonia and evidence of systemic inflammation. PMID 35290169 ↗

Publications

Criner GJ, Lang FM, Gottlieb RL, Mathews KS, Wang TS, Rice TW, Madduri D, Bellam S, Jeanfreau R, Case AH, Glassberg MK, Lyon GM, Ahmad K, Mendelson R, DiMaio JM, Tran MP, Spak CW, Abbasi JA, Davis SG, Ghamande S, Shen S, Sherman L, Lowry S. Anti-Granulocyte-Macrophage Colony-Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1290-1299. doi: 10.1164/rccm.202108-1859OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gimsilumab	Monoclonal antibody	200 mg	Intravenous