A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia
NCT ID: NCT04386616
Last Updated: 2022-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
396 participants
INTERVENTIONAL
2020-06-02
2021-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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All Placebo
Participants randomized to this arm received one intravenous (IV) infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo on Day 1. A second IV infusion of either MSTT1041A-matched placebo or UTTR1147A-matched placebo (same placebo as the first infusion) was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
MSTT1041A-matched Placebo
Participants received up to 2 intravenous infusions of MSTT1041A-matched placebo.
UTTR1147A-matched Placebo
Participants received up to 2 intravenous infusions of UTTR1147A-matched placebo.
MSTT1041A
Participants randomized to this arm 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. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
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.
UTTR1147A
Participants randomized to this arm 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. Study treatment was given in combination with the standard of care for COVID-19 pneumonia.
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.
Interventions
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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.
MSTT1041A-matched Placebo
Participants received up to 2 intravenous infusions of MSTT1041A-matched placebo.
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.
UTTR1147A-matched Placebo
Participants received up to 2 intravenous infusions of UTTR1147A-matched placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Staten Island University Hospital; Department of Pharmacy
Staten Island, New York, United States
Lincoln Medical Mental Health Center
The Bronx, 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, Rio de Janeiro, Brazil
Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital E Maternidade Celso Pierro PUCCAMP
Campinas, São Paulo, Brazil
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México, , Mexico
Instituto Nacional De Enfermedades Respiratorias INER National Institute of Respiratory Diseases
México, , Mexico
Hospital General de Tijuana
Tijuana, , Mexico
Hospital Universitario de Bellvitge
L'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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2020-002713-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OT number: HHSO100201800036C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GA42469
Identifier Type: -
Identifier Source: org_study_id
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