A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia

Phase 2 Completed 396 enrolled Genentech, Inc. Biomedical Advanced Research and Development Authority · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) compared with placebo and of UTTR1147A compared with placebo, in combination with standard of care (SOC), in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

Timeline

Start: 2020-06-02
Primary completion: 2021-01-08
Completion: 2021-02-12

Outcome

Missed primary endpoint

registry analysis (superiority test); All Placebo vs MSTT1041A; p = 0.9266; Hazard Ratio (HR) 1.01 (95% CI 0.75 to 1.36) NCT04386616 ↗

registry analysis (superiority test); All Placebo vs UTTR1147A; p = 0.3570; Hazard Ratio (HR) 1.15 (95% CI 0.86 to 1.54) NCT04386616 ↗

paper Treatment with astegolimab or efmarodocokin alfa did not improve time to recovery in patients with severe COVID-19 pneumonia. PMID 36519984 ↗

Publications

Waters M, McKinnell JA, Kalil AC, Martin GS, Buchman TG, Theess W, Yang X, Lekkerkerker AN, Staton T, Rosenberger CM, Pappu R, Wang Y, Zhang W, Brooks L, Cheung D, Galanter J, Chen H, Mohan D, Peck MC; COVID-astegolimab-interleukin (IL) (COVASTIL) Study Group. Astegolimab or Efmarodocokin Alfa in Patients With Severe COVID-19 Pneumonia: A Randomized, Phase 2 Trial. Crit Care Med. 2023 Jan 1;51(1):103-116. doi: 10.1097/CCM.0000000000005716. Epub 2022 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Astegolimab	Monoclonal antibody	350 mg	Intravenous
Subject	UTTR1147A	Protein / enzyme biologic	90 ug/kg	Intravenous