NCT04386616

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

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients With Severe COVID-19 Pneumonia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	MSTT1041A	Participants received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen.
DRUG	MSTT1041A-matched Placebo	Participants received up to 2 intravenous infusions of MSTT1041A-matched placebo.
DRUG	UTTR1147A	Participants received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen.
DRUG	UTTR1147A-matched Placebo	Participants received up to 2 intravenous infusions of UTTR1147A-matched placebo.

Timeline

• Start date: 2020-06-02
• Primary completion: 2021-01-08
• Completion: 2021-02-12
• First posted: 2020-05-13
• Last updated: 2022-01-10
• Results posted: 2022-01-10

Locations

41 sites across 4 countries: United States, Brazil, Mexico, Spain

Regulatory

• FDA-regulated drug study