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

Primary Purpose

COVID-19 Pneumonia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MSTT1041A

MSTT1041A-matched Placebo

UTTR1147A

UTTR1147A-matched Placebo

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Arkansas For Medical Sciences
eStudySite - Chula Vista - PPDS
eStudySite
Torrance Memorial Medical Center
Denver Health Medical Center
Bay Pines VA Medical Center - NAVREF
WellStar Research Institute
DM Clinical Research - Alexandria Cardiology Clinic - ERN - PPDS
MedPharmics
Southeast Louisiana Veterans Health Care System - NAVREF
Henry Ford Health System
St. Joseph'S Regional Medical Center
San Juan Oncology Associates
Albany Medical Center
Lincoln Medical Mental Health Center
Staten Island University Hospital; Department of Pharmacy
Mercy St. Vincent Medical Center
Providence Portland Medical Center; Investigational Drug Services/Regional Research
Lehigh Valley Health Network
Parkland Health & Hospital System
University of Texas Southwestern Medical Center
Virginia Commonwealth University
Virginia Mason Medical Center
MultiCare Institute for Research and Innovation; Clinic/Outpatient Facility
Instituto de Pesquisa Clinica Evandro Chagas FIOCRUZ
Santa Casa de Porto Alegre
Hospital E Maternidade Celso Pierro PUCCAMP
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Hospital Alemao Oswaldo Cruz
Instituto do Coração - HCFMUSP
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional De Enfermedades Respiratorias INER National Institute of Respiratory Diseases
Hospital General de Tijuana
Hospital Universitario de Bellvitge
Hospital Costa del Sol; Servicio de Oncologia
Hospital del Mar
Hospital General Universitario de Guadalajara
Complejo Asistencial Universitario de Salamanca - H. Clinico
Hospital Clinico Universitario Valladolid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

All Placebo

MSTT1041A

UTTR1147A

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The 7 categories of the clinical status ordinal scale 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 ECMO or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death

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

Hospital discharge is category number 1 out of the 7 categories of the clinical status ordinal scale, and it is 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).

Duration of Supplemental Oxygen by Day 28

Duration of supplemental oxygen was defined as the number of days during the 28-day treatment period when the participant is alive and receives "Supplemental Oxygen or other forms of ventilation", as recorded in the Vital Signs and Oxygen Saturation form. For each participant, the duration of multiple non-consecutive periods during which the participant received supplemental oxygen was summed. For any days prior to Day 28 where status of supplemental oxygen use was missing, the last known status was to be carried forward.

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

Respiratory failure was defined as requiring non-invasive ventilation, high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO]).

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

The clinical status scores of the 7 category ordinal scale 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 ECMO or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7. Death

Clinical Status Score at Day 28, Assessed Using a 7-Category Ordinal Scale

Percentage of Participants Needing Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Day 28

Number of Ventilator-Free Days by Day 28

The number of ventilator-free days was defined as the number of days during the 28-day treatment period when the participant is alive and without need for invasive mechanical ventilation. For any day during Day 1 and Day 28, if invasive mechanical ventilation or ECMO was recorded for any part of the day ( >= 12 hours during mechanical invasive ventilation for patients with tracheostomy), the day was not to be counted as a ventilator-free day; otherwise, the day was to be counted. For any days prior to Day 28 where status of mechanical ventilator was missing, the last known status was to be carried forward. The total number of days was the sum of all ventilator-free days, regardless of whether the days occurred consecutively or in nonconsecutive intervals.

Percentage of Participants With an Intensive Care Unit (ICU) Stay by Day 28

Duration of Intensive Care Unit (ICU) Stay by Day 28

Duration of ICU stay was calculated as the total number of hours (expressed in days) spent in ICU up to and inclusive of 28 days. ICU duration was derived from the ICU Stay Information Log using the difference between ICU discharge date/time and ICU admission date/time. If ICU admission occurred before randomization, the ICU duration was to be counted from the date of dosing. Partial admission and discharge date/time were to be imputed following a conservative approach. For each participant, durations of multiple ICU stays were to be summed.

Time to Clinical Failure by Day 28, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal of Care (Whichever Occurs First)

Percentage of Participants Who Died by Day 14

Percentage of Participants Who Died by Day 28

Time to Clinical Improvement, Defined as a National Early Warning Score 2 (NEWS2) Aggregate Score of ≤2 Maintained for 24 Hours

The National Early Warning Score 2 (NEWS2) is a system for scoring the physiological measurements that are routinely recorded at the patient's bedside. Its purpose is to identify acutely ill patients. The NEWS2 scoring system measures 7 physiological parameters: respiration rate, peripheral capillary oxygen saturation, breathing air or supplementary oxygen, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, and body temperature. A score of 0, 1, 2, or 3 is allocated to each parameter (except for air or oxygen, with respective scores of 0 and 2); a higher score means the parameter is further from the normal range. The scores for each parameter are then summed (with an aggregate score ranging from 0 to 20), and a higher aggregate score indicates a worse clinical condition of the patient, thus indicating the need for a more urgent clinical response.

Safety Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

The terms "severe" and "serious" are not synonymous with respect to an adverse event (AE). Severity refers to the intensity of an AE (rated according to NCI-CTCAE v5.0 criteria or, if not listed, the following scale: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), whereas a serious AE (SAE) is a significant medical event (per standard SAE criteria), such as a life-threatening or fatal AE or an AE that prolongs inpatient hospitalization. Severity and seriousness were independently assessed by the investigator for each AE that was recorded. The investigator also assessed each AE for whether the event was considered to be related to the study drug.

Number of Participants With Clinical Laboratory Test Abnormalities by Highest NCI-CTCAE Grade Post-Baseline

Clinical laboratory tests were performed over the course of the study and the grading of any abnormal values outside of the normal range (High or Low) was based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0); the higher the grade, the greater the lab parameter deviated from the normal range. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase; INR = international normalized ratio; aPTT = activated partial thromboplastin time

Number of Participants With Vital Sign Abnormalities at Anytime Post-Baseline

The number of participants with vital sign abnormalities outside of the normal upper (i.e., High) and lower limits (i.e., Low) were summarized for each parameter. The normal reference range used for each vital sign parameter was as follows: Diastolic Blood Pressure, 50-90 millimetres of mercury (mmHg); Oxygen Saturation, ≥94%; Pulse Rate, 60-100 beats per minute; Respiratory Rate, 8-20 breaths per minute; Systolic Blood Pressure, 90-140 mmHg; Temperature, 36.5-38 degrees Celsius (C). Not every vital sign abnormality qualified as an adverse event. A vital sign result was to be reported as an adverse event if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgement.

Number of Participants by the Investigator's Interpretations of Electrocardiogram Recordings at Specified Timepoints

Electrocardiogram (ECG) recordings were to be performed after the participant had been resting in a supine position for at least 10 minutes if possible. The investigator's interpretation of the ECG (e.g., normal or abnormal) was recorded.

Percentage of Participants Who Tested Positive for Anti-Drug Antibodies (ADAs) to MSTT1041A and UTTR1147A at Baseline and at Anytime Post-Baseline

Serum samples were collected, and participants who received treatment with MSTT1041A or MSTT1041A-matched placebo were assessed for antidrug antibodies (ADAs) to MSTT1041A, while those who received UTTR1147A or UTTR1147A-matched placebo were assessed for ADAs to UTTR1147A. Participants who received placebo treatment were only assessed for the presence of ADAs at baseline. The percentage of ADA-positive participants at baseline (baseline prevalence) and after drug administration (postbaseline incidence) are summarized. When determining postbaseline incidence, participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response).

Serum Concentration of UTTR1147A at Specified Timepoints

Serum Concentration of MSTT1041A at Specified Timepoints

Full Information

NCT ID

NCT04386616

First Posted

May 11, 2020

Last Updated

January 5, 2022

Sponsor

Genentech, Inc.

Collaborators

Biomedical Advanced Research and Development Authority

1. Study Identification

Unique Protocol Identification Number

NCT04386616

Brief Title

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

Acronym

COVASTIL

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 2, 2020 (Actual)

Primary Completion Date

January 8, 2021 (Actual)

Study Completion Date

February 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

Collaborators

Biomedical Advanced Research and Development Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

MSTT1041A

Arm Type

Experimental

Arm Description

Arm Title

UTTR1147A

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MSTT1041A

Other Intervention Name(s)

Astegolimab, RG6149, RO7187807

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

MSTT1041A-matched Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

UTTR1147A

Other Intervention Name(s)

Efmarodocokin alfa, RG7880, RO7021610, IL-22Fc

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

UTTR1147A-matched Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

From Baseline up to 28 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

From Baseline up to 28 days

Title

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

Description

Time Frame

Up to 28 days

Title

Duration of Supplemental Oxygen by Day 28

Description

Time Frame

Up to 28 days

Title

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

Description

Respiratory failure was defined as requiring non-invasive ventilation, high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO]).

Time Frame

Up to 28 days

Title

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

Description

Time Frame

Day 14

Title

Clinical Status Score at Day 28, Assessed Using a 7-Category Ordinal Scale

Description

Time Frame

Day 28

Title

Percentage of Participants Needing Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Day 28

Time Frame

Up to 28 days

Title

Number of Ventilator-Free Days by Day 28

Description

Time Frame

Up to 28 days

Title

Percentage of Participants With an Intensive Care Unit (ICU) Stay by Day 28

Time Frame

Up to 28 days

Title

Duration of Intensive Care Unit (ICU) Stay by Day 28

Description

Time Frame

Up to 28 days

Title

Time to Clinical Failure by Day 28, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal of Care (Whichever Occurs First)

Time Frame

Up to 28 days

Title

Percentage of Participants Who Died by Day 14

Time Frame

Up to Day 14

Title

Percentage of Participants Who Died by Day 28

Time Frame

Up to Day 28

Title

Time to Clinical Improvement, Defined as a National Early Warning Score 2 (NEWS2) Aggregate Score of ≤2 Maintained for 24 Hours

Description

Time Frame

Up to 28 days

Title

Description

Time Frame

From Baseline until study completion/discontinuation (up to 60 days)

Title

Number of Participants With Clinical Laboratory Test Abnormalities by Highest NCI-CTCAE Grade Post-Baseline

Description

Time Frame

From Baseline up to 60 days

Title

Number of Participants With Vital Sign Abnormalities at Anytime Post-Baseline

Description

Time Frame

From Baseline up to 60 days

Title

Number of Participants by the Investigator's Interpretations of Electrocardiogram Recordings at Specified Timepoints

Description

Time Frame

Baseline, Days 14 and 28, Discharge Day (up to Day 28), and Study Completion Visit (up to Day 60)

Title

Percentage of Participants Who Tested Positive for Anti-Drug Antibodies (ADAs) to MSTT1041A and UTTR1147A at Baseline and at Anytime Post-Baseline

Description

Time Frame

At Baseline (pre-dose on Day 1) and post-baseline (Days 15 and 28; and discharge day and study completion [up to 60 days])

Title

Serum Concentration of UTTR1147A at Specified Timepoints

Time Frame

For the first dose: at 0.5 hours post-dose on Day 1, on Days 2, 3, 7, and 15; and for the second dose: Days 15 (0.5 hours post-dose), 21, and 28

Title

Serum Concentration of MSTT1041A at Specified Timepoints

Time Frame

For the first dose: at 0.5 hours post-dose on Day 1, on Days 2, 3, 7, and 15; and for the second dose: Days 15 (0.5 hours post-dose), 21, and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of Arkansas For Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

eStudySite - Chula Vista - PPDS

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

eStudySite

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Torrance Memorial Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Denver Health Medical Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

Bay Pines VA Medical Center - NAVREF

City

Bay Pines

State/Province

Florida

ZIP/Postal Code

33744

Country

United States

Facility Name

WellStar Research Institute

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

DM Clinical Research - Alexandria Cardiology Clinic - ERN - PPDS

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

MedPharmics

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Southeast Louisiana Veterans Health Care System - NAVREF

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

St. Joseph'S Regional Medical Center

City

Paterson

State/Province

New Jersey

ZIP/Postal Code

07503

Country

United States

Facility Name

San Juan Oncology Associates

City

Farmington

State/Province

New Mexico

ZIP/Postal Code

87401

Country

United States

Facility Name

Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Lincoln Medical Mental Health Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10451

Country

United States

Facility Name

Staten Island University Hospital; Department of Pharmacy

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Mercy St. Vincent Medical Center

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Providence Portland Medical Center; Investigational Drug Services/Regional Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Lehigh Valley Health Network

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Parkland Health & Hospital System

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23292

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

MultiCare Institute for Research and Innovation; Clinic/Outpatient Facility

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Instituto de Pesquisa Clinica Evandro Chagas FIOCRUZ

City

Rio de Janeiro

State/Province

ZIP/Postal Code

21040-360

Country

Brazil

Facility Name

Santa Casa de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90020-090

Country

Brazil

Facility Name

Hospital E Maternidade Celso Pierro PUCCAMP

City

Campinas

State/Province

ZIP/Postal Code

13060-904

Country

Brazil

Facility Name

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

City

Sao Jose Do Rio Preto

State/Province

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Hospital Alemao Oswaldo Cruz

City

Sao Paulo

State/Province

ZIP/Postal Code

01323-903

Country

Brazil

Facility Name

Instituto do Coração - HCFMUSP

City

Sao Paulo

State/Province

ZIP/Postal Code

05403-900

Country

Brazil

Facility Name

Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

Hospital Universitario Dr. Jose Eleuterio Gonzalez

City

Monterrey

State/Province

Nuevo LEON

Country

Mexico

Facility Name

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

City

Mexico

Country

Mexico

Facility Name

Instituto Nacional De Enfermedades Respiratorias INER National Institute of Respiratory Diseases

City

Mexico

Country

Mexico

Facility Name

Hospital General de Tijuana

City

Tijuana

ZIP/Postal Code

22320

Country

Mexico

Facility Name

Hospital Universitario de Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Costa del Sol; Servicio de Oncologia

City

Marbella

State/Province

Malaga

ZIP/Postal Code

29603

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital General Universitario de Guadalajara

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

Complejo Asistencial Universitario de Salamanca - H. Clinico

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hospital Clinico Universitario Valladolid

City

Valladolid

ZIP/Postal Code

47005

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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