Official Title
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
Brief 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.

Completed
COVID-19 Pneumonia

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.
Other Name: Array

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.
Other Name: Array

Drug: UTTR1147A-matched Placebo

Participants received up to 2 intravenous infusions of UTTR1147A-matched placebo.

Eligibility Criteria

Inclusion Criteria:

- Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive
PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and
evidenced by chest X-ray or CT scan

- Peripheral capillary oxygen saturation (SpO2) ≤93% (on room air or supplemental
oxygen) or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤300
millimetres of mercury (mmHg) or requiring supplemental oxygen to maintain SpO2 >93%
or requirement for supplemental oxygen to maintain SpO2 at an acceptable level per
local standard of care

Exclusion Criteria:

- Pregnant or breastfeeding, or positive pregnancy test at screening

- Any serious medical condition or abnormality of clinical laboratory tests that, in the
investigator's judgment, precludes the patient's safe participation in and completion
of the study

- In the opinion of the investigator, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatments

- Participating in another clinical drug trial

- Treatment with investigational therapy (other than for COVID-19) within 5 half-lives
or 30 days (whichever is longer) prior to initiation of study drug

- Use of Janus kinase (JAK) inhibitor within 30 days or 5 drug elimination half-lives
(whichever is longer) prior to screening

- Have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or
equivalent) within 72 hours prior to Day 1

- Known HIV infection with CD4 <200 cells/microlitre (uL) or <14% of all lymphocytes

- ALT or AST >10 times the upper limit of normal (ULN) detected at screening

- History of anaplastic large-cell lymphoma or mantle-cell lymphoma

- History of cancer within the previous 5 years unless it has been adequately treated
and considered cured or remission-free in the investigator's judgment

- Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial
ischemia or decompensated heart failure), as determined by investigator assessment,
ECG, laboratory assessment, or echocardiographic data

- History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or
hypersensitivity to any component of study treatment

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Mexico
Spain
United States
Locations

University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States

eStudySite - Chula Vista - PPDS
Chula Vista, California, United States

eStudySite
La Mesa, California, United States

Torrance Memorial Medical Center
Torrance, California, United States

Denver Health Medical Center
Denver, Colorado, United States

Bay Pines VA Medical Center - NAVREF
Bay Pines, Florida, United States

WellStar Research Institute
Marietta, Georgia, United States

DM Clinical Research - Alexandria Cardiology Clinic - ERN - PPDS
Alexandria, Louisiana, United States

MedPharmics
Metairie, Louisiana, United States

Southeast Louisiana Veterans Health Care System - NAVREF
New Orleans, Louisiana, United States

Henry Ford Health System
Detroit, Michigan, United States

St. Joseph'S Regional Medical Center
Paterson, New Jersey, United States

San Juan Oncology Associates
Farmington, New Mexico, United States

Albany Medical Center
Albany, New York, United States

Lincoln Medical Mental Health Center
Bronx, New York, United States

Staten Island University Hospital; Department of Pharmacy
Staten Island, New York, United States

Mercy St. Vincent Medical Center
Toledo, Ohio, United States

Providence Portland Medical Center; Investigational Drug Services/Regional Research
Portland, Oregon, United States

Lehigh Valley Health Network
Allentown, Pennsylvania, United States

Parkland Health & Hospital System
Dallas, Texas, United States

University of Texas Southwestern Medical Center
Dallas, Texas, United States

Virginia Commonwealth University
Richmond, Virginia, United States

Virginia Mason Medical Center
Seattle, Washington, United States

MultiCare Institute for Research and Innovation; Clinic/Outpatient Facility
Tacoma, Washington, United States

Instituto de Pesquisa Clinica Evandro Chagas FIOCRUZ
Rio de Janeiro, RJ, Brazil

Santa Casa de Porto Alegre
Porto Alegre, RS, Brazil

Hospital E Maternidade Celso Pierro PUCCAMP
Campinas, SP, Brazil

Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto, SP, Brazil

Hospital Alemao Oswaldo Cruz
Sao Paulo, SP, Brazil

Instituto do Coração - HCFMUSP
Sao Paulo, SP, Brazil

Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo LEON, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, Mexico

Instituto Nacional De Enfermedades Respiratorias INER National Institute of Respiratory Diseases
Mexico, Mexico

Hospital General de Tijuana
Tijuana, Mexico

Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain

Hospital Costa del Sol; Servicio de Oncologia
Marbella, Malaga, Spain

Hospital del Mar
Barcelona, Spain

Hospital General Universitario de Guadalajara
Guadalajara, Spain

Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain

Hospital Clinico Universitario Valladolid
Valladolid, Spain

Clinical Trials, Study Director
Genentech, Inc.

Biomedical Advanced Research and Development Authority
NCT Number
MeSH Terms
COVID-19
Pneumonia
Astegolimab