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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386616
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: MSTT1041A Drug: MSTT1041A-matched Placebo Drug: UTTR1147A Drug: UTTR1147A-matched Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : September 24, 2020
Estimated Study Completion Date : October 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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

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

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.




Primary Outcome Measures :
  1. Clinical Status, Assessed Using a 7-Category Ordinal Scale [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
  4. Incidence of Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: Up to 60 days ]
  5. Ventilator-Free Days [ Time Frame: Up to 28 days ]
  6. Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
  7. Duration of ICU Stay [ Time Frame: Up to 60 days ]
  8. 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 ]
  9. Mortality Rate at Days 7, 14, 21, 28, and 60 [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  10. Time to Hospital Discharge or "Ready for Discharge" [ Time Frame: Up to 60 days ]
  11. Duration of Supplemental Oxygen [ Time Frame: Up to 60 days ]
  12. Percentage of Participants Alive and Free of Respiratory Failure [ Time Frame: Day 28 ]
  13. 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 ]
  14. Change from Baseline in Respiratory Rate [ Time Frame: From Baseline up to 60 days ]
  15. Change from Baseline in Pulse Rate [ Time Frame: From Baseline up to 60 days ]
  16. Change from Baseline in Systolic Blood Pressure [ Time Frame: From Baseline up to 60 days ]
  17. Change from Baseline in Diastolic Blood Pressure [ Time Frame: From Baseline up to 60 days ]
  18. Change from Baseline in Body Temperature [ Time Frame: From Baseline up to 60 days ]
  19. Change from Baseline in Oxygen Saturation [ Time Frame: From Baseline up to 60 days ]
  20. Change from Baseline in RR, QRS, PR, QT, and QTcF Intervals, as Measured by Electrocardiogram (ECG) [ Time Frame: From Baseline up to 60 days ]
  21. Change from Baseline in Heart Rate, as Measured by Electrocardiogram (ECG) [ Time Frame: From Baseline up to 60 days ]
  22. Number of Participants with Clinical Laboratory Test Abnormalities in Hematology Parameters [ Time Frame: From Baseline up to 60 days ]
  23. Number of Participants with Clinical Laboratory Test Abnormalities in Blood Chemistry Parameters [ Time Frame: From Baseline up to 60 days ]
  24. Serum Concentration of UTTR1147A at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Study Completion (up to 60 days) ]
  25. Serum Concentration of MSTT1041A at Specified Timepoints [ Time Frame: At predefined timepoints from Baseline until Study Completion (up to 60 days) ]
  26. Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study [ Time Frame: From Baseline up to 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386616


Contacts
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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

Locations
Show Show 42 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04386616    
Other Study ID Numbers: GA42469
2020-002713-17 ( EudraCT Number )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
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).


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections