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

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Genentech, Inc.
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Updated on 5 August 2020
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ct scan
pao2
FIO2
x-rays
pneumonia
oximetry
chest x-ray
coronavirus infection
capillary oxygen saturation
fraction of inspired oxygen (fio2)

Summary

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) or UTTR1147A in combination with standard of care (SOC) compared with matching placebo in combination with SOC in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

Details
Condition COVID-19 Pneumonia
Age 18years - 100years
Treatment MSTT1041A, MSTT1041A-matched Placebo, UTTR1147A, UTTR1147A-matched Placebo
Clinical Study IdentifierNCT04386616
SponsorGenentech, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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%

Exclusion Criteria

Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
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 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
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