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

NCT04386616 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: GA424692020-002713-17OT number: HHSO100201800036C
• Study Type: interventional
• Target: 396
• Locations: 4 countries
• Sites: 41

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Time to Recovery, Defined as the Time to a Clinical Status Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) by Day 28

  The time to recovery was defined as the time from baseline to a clinical status score of 1 or 2 on the 7-category ordinal scale (whichever occurs first); clinical status scores are defined as follows: 1. Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2 Litres supplemental oxygen); 2. Non-Intensive Care Unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen; 3. Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen; 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen; 5. ICU, requiring intubation and mechanical ventilation; 6. ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death.

  From Baseline up to 28 days

Secondary Outcomes (21)

• Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status by Day 28

  From Baseline up to 28 days

• Time to Hospital Discharge or "Ready for Discharge" by Day 28

  Up to 28 days

• Duration of Supplemental Oxygen by Day 28

  Up to 28 days

• Percentage of Participants Alive and Free of Respiratory Failure by Day 28

  Up to 28 days

• Clinical Status Score at Day 14, Assessed Using a 7-Category Ordinal Scale

  Day 14

Study Arms (3)

All Placebo

PLACEBO COMPARATOR

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.

Drug: MSTT1041A-matched Placebo; Drug: UTTR1147A-matched Placebo

MSTT1041A

EXPERIMENTAL

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.

Drug: MSTT1041A

UTTR1147A

EXPERIMENTAL

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.

Drug: UTTR1147A

Interventions

MSTT1041A DRUG

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.

Also known as: Astegolimab, RG6149, RO7187807

MSTT1041A

MSTT1041A-matched Placebo DRUG

Participants received up to 2 intravenous infusions of MSTT1041A-matched placebo.

All Placebo

UTTR1147A DRUG

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.

Also known as: Efmarodocokin alfa, RG7880, RO7021610, IL-22Fc

UTTR1147A

UTTR1147A-matched Placebo DRUG

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

All Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (41)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

eStudySite - Chula Vista - PPDS

Chula Vista, California, 91911, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Bay Pines VA Medical Center - NAVREF

Bay Pines, Florida, 33744, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

DM Clinical Research - Alexandria Cardiology Clinic - ERN - PPDS

Alexandria, Louisiana, 71301, United States

Location

MedPharmics

Metairie, Louisiana, 70006, United States

Location

Southeast Louisiana Veterans Health Care System - NAVREF

New Orleans, Louisiana, 70112, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

St. Joseph'S Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Staten Island University Hospital; Department of Pharmacy

Staten Island, New York, 10305, United States

Location

Lincoln Medical Mental Health Center

The Bronx, New York, 10451, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Providence Portland Medical Center; Investigational Drug Services/Regional Research

Portland, Oregon, 97213, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23292, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MultiCare Institute for Research and Innovation; Clinic/Outpatient Facility

Tacoma, Washington, 98405, United States

Location

Instituto de Pesquisa Clinica Evandro Chagas FIOCRUZ

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital E Maternidade Celso Pierro PUCCAMP

Campinas, São Paulo, 13060-904, Brazil

Location

Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01323-903, Brazil

Location

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403-900, Brazil

Location

Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca

Guadalajara, Jalisco, 44340, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, Mexico

Location

Instituto Nacional De Enfermedades Respiratorias INER National Institute of Respiratory Diseases

México, Mexico

Location

Hospital General de Tijuana

Tijuana, 22320, Mexico

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Costa del Sol; Servicio de Oncologia

Marbella, Malaga, 29603, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital General Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, 37007, Spain

Location

Hospital Clinico Universitario Valladolid

Valladolid, 47005, Spain

Location

Related Publications (1)

• 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.

  PMID: 36519984 DERIVED

MeSH Terms

Interventions

astegolimab

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 13, 2020
• Study Start: June 2, 2020
• Primary Completion: January 8, 2021
• Study Completion: February 12, 2021
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

ME (5); US (24); ES (6); BR (6)