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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386616
Recruitment Status : Completed
First Posted : May 13, 2020
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE May 11, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE June 2, 2020
Actual Primary Completion Date January 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
Time to Recovery, Defined as the Time to a Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
Clinical Status, Assessed Using a 7-Category Ordinal Scale [ Time Frame: Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2020)
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: From Baseline up to 28 days ]
  • Time to Hospital Discharge or "Ready for Discharge" [ Time Frame: Up to 28 days ]
  • Duration of Supplemental Oxygen [ Time Frame: Up to 28 days ]
  • Percentage of Participants Alive and Free of Respiratory Failure [ Time Frame: Day 28 ]
  • Clinical Status, Assessed Using a 7-Category Ordinal Scale [ Time Frame: Days 14 and 28 ]
  • Incidence of Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: Up to 28 days ]
  • Ventilator-Free Days [ Time Frame: Up to 28 days ]
  • Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 28 days ]
  • Duration of ICU Stay [ Time Frame: Up to 28 days ]
  • Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal of Care (Whichever Occurs First) [ Time Frame: Up to 28 days ]
  • Mortality Rate at Days 14 and 28 [ Time Frame: Days 14 and 28 ]
  • Time to Clinical Improvement, Defined as a National Early Warning Score 2 (NEWS2) of ≤2 Maintained for 24 hours [ Time Frame: Up to 28 days ]
  • Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) [ Time Frame: Up to 60 days ]
  • Change from Baseline in Respiratory Rate [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Pulse Rate [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Body Temperature [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Oxygen Saturation [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in RR, QRS, PR, QT, and QTcF Intervals, as Measured by Electrocardiogram (ECG) [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Heart Rate, as Measured by Electrocardiogram (ECG) [ Time Frame: From Baseline up to 60 days ]
  • Number of Participants with Clinical Laboratory Test Abnormalities in Hematology Parameters [ Time Frame: From Baseline up to 60 days ]
  • Number of Participants with Clinical Laboratory Test Abnormalities in Blood Chemistry Parameters [ Time Frame: From Baseline up to 60 days ]
  • Serum Concentration of UTTR1147A at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Study Completion (up to 60 days) ]
  • Serum Concentration of MSTT1041A at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Study Completion (up to 60 days) ]
  • Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study [ Time Frame: From Baseline up to 60 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Time to Clinical Improvement, Defined as a National Early Warning Score 2 (NEWS2) of ≤2 Maintained for 24 hours [ Time Frame: Up to 60 days ]
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: From Baseline up to 60 days ]
  • Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
  • Ventilator-Free Days [ Time Frame: Up to 28 days ]
  • Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
  • Duration of ICU Stay [ Time Frame: Up to 60 days ]
  • Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal of Care (Whichever Occurs First) [ Time Frame: Up to 60 days ]
  • Mortality Rate at Days 7, 14, 21, 28, and 60 [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  • Time to Hospital Discharge or "Ready for Discharge" [ Time Frame: Up to 60 days ]
  • Duration of Supplemental Oxygen [ Time Frame: Up to 60 days ]
  • Duration of Hypoxemia [ Time Frame: Up to 60 days ]
  • Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) [ Time Frame: Up to 60 days ]
  • Change from Baseline in Respiratory Rate [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Pulse Rate [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Body Temperature [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Oxygen Saturation [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in RR, QRS, PR, QT, and QTcF Intervals, as Measured by Electrocardiogram (ECG) [ Time Frame: From Baseline up to 60 days ]
  • Change from Baseline in Heart Rate, as Measured by Electrocardiogram (ECG) [ Time Frame: From Baseline up to 60 days ]
  • Number of Participants with Clinical Laboratory Test Abnormalities in Hematology Parameters [ Time Frame: From Baseline up to 60 days ]
  • Number of Participants with Clinical Laboratory Test Abnormalities in Blood Chemistry Parameters [ Time Frame: From Baseline up to 60 days ]
  • Serum Concentration of UTTR1147A at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Study Completion (up to 60 days) ]
  • Serum Concentration of MSTT1041A at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Study Completion (up to 60 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE
  • 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.
  • Drug: UTTR1147A
    Participants will receive up to 2 intravenous infusions of UTTR1147A.
    Other Names:
    • Efmarodocokin alfa
    • RG7880
    • RO7021610
    • IL-22Fc
  • Drug: UTTR1147A-matched Placebo
    Participants will receive up to 2 intravenous infusions of UTTR1147A-matched placebo.
Study Arms  ICMJE
  • Experimental: MSTT1041A
    Participants randomized to this arm will receive MSTT1041A. Study treatment will be given in combination with standard of care.
    Intervention: Drug: MSTT1041A
  • 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.
    Intervention: Drug: MSTT1041A-matched Placebo
  • Experimental: UTTR1147A
    Participants randomized to this arm will receive UTTR1147A. Study treatment will be given in combination with standard of care.
    Intervention: Drug: UTTR1147A
  • 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.
    Intervention: Drug: UTTR1147A-matched Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2020)
410
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
300
Actual Study Completion Date  ICMJE February 12, 2021
Actual Primary Completion Date January 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Mexico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04386616
Other Study ID Numbers  ICMJE GA42469
2020-002713-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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).

Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP