Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2021
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04386616
Start Date
June 2 2020
End Date
February 12 2021
Last Update
January 10 2022
Active Locations (41)
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1
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
2
eStudySite - Chula Vista - PPDS
Chula Vista, California, United States, 91911
3
eStudySite
La Mesa, California, United States, 91942
4
Torrance Memorial Medical Center
Torrance, California, United States, 90505