Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MSTT1041A
Participants randomized to this arm will receive MSTT1041A. Study treatment will be given in combination with standard of care.
  • Drug: MSTT1041A
    Participants will receive up to 2 intravenous infusions of MSTT1041A.
    Other names:
    • Astegolimab
    • RG6149
    • RO7187807
  • Drug: MSTT1041A-matched Placebo
    Participants will receive up to 2 intravenous infusions of MSTT1041A-matched placebo.
Placebo Comparator
MSTT1041A-matched Placebo
Participants randomized to this arm will receive MSTT1041A-matched placebo. Study treatment will be given in combination with standard of care.
  • Drug: MSTT1041A-matched Placebo
    Participants will receive up to 2 intravenous infusions of MSTT1041A-matched placebo.
Experimental
UTTR1147A
Participants randomized to this arm will receive UTTR1147A. Study treatment will be given in combination with standard of care.
  • Drug: UTTR1147A
    Participants will receive up to 2 intravenous infusions of UTTR1147A.
    Other names:
    • RG7880
    • RO7021610
    • IL-22Fc
  • Drug: UTTR1147A-matched Placebo
    Participants will receive up to 2 intravenous infusions of UTTR1147A-matched placebo.
Placebo Comparator
UTTR1147A-matched Placebo
Participants randomized to this arm will receive UTTR1147A-matched placebo. Study treatment will be given in combination with standard of care.
  • Drug: UTTR1147A-matched Placebo
    Participants will receive up to 2 intravenous infusions of UTTR1147A-matched placebo.

Recruiting Locations

University of Arkansas For Medical Sciences
Little Rock, Arkansas 72205

eStudySite - Chula Vista - PPDS
Chula Vista, California 91911

eStudySite
La Mesa, California 91942

Alta Bates Summit Medical Center
Oakland, California 94609

Torrance Memorial Medical Center
Torrance, California 90505

Denver Health Medical Center
Denver, Colorado 80204

Bay Pines VA Medical Center - NAVREF
Bay Pines, Florida 33744

Larkin Community Hospital Palm Springs Campus (Hialeah)
Hialeah, Florida 33012

Larkin Community Hospital
South Miami, Florida 33143

Northside Hospital; Peachtree Dunwoody Medical Center
Atlanta, Georgia 30342

WellStar Research Institute
Marietta, Georgia 30060

University Of Iowa Hospitals And Clinics
Coralville, Iowa 52241-2209

DM Clinical Research - Alexandria Cardiology Clinic - ERN - PPDS
Alexandria, Louisiana 71301

MedPharmics
Metairie, Louisiana 70006

Southeast Louisiana Veterans Health Care System - NAVREF
New Orleans, Louisiana 70112

Henry Ford Health System
Detroit, Michigan 48202

St. Joseph'S Regional Medical Center
Paterson, New Jersey 07503

San Juan Oncology Associates
Farmington, New Mexico 87401

Albany Medical Center
Albany, New York 12208

Lincoln Medical Mental Health Center
Bronx, New York 10451

Jacobi Medical Center; Lewis M. Fraad Department of Pediatrics
Bronx, New York 10461

Staten Island University Hospital; Department of Pharmacy
Staten Island, New York 10305

Cape Fear Valley Health System
Fayetteville, North Carolina 28304

Mercy St. Vincent Medical Center
Toledo, Ohio 43608

Providence Portland Medical Center; Investigational Drug Services/Regional Research
Portland, Oregon 97213

Lehigh Valley Health Network
Allentown, Pennsylvania 18103

Temple Uni Medical Center; Pulmonary & Critical Care Medicine
Philadelphia, Pennsylvania 19140

Parkland Health & Hospital System
Dallas, Texas 75235

University of Texas Southwestern Medical Center
Dallas, Texas 75390

Virginia Commonwealth University
Richmond, Virginia 23292

Virginia Mason Medical Center
Seattle, Washington 98101

MultiCare Institute for Research and Innovation; Clinic/Outpatient Facility
Tacoma, Washington 98405

More Details

NCT ID
NCT04386616
Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GA42469 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.