Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
NCT ID: NCT04412668
Last Updated: 2023-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2020-06-04
2020-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efzofitimod 1 mg/kg
Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1.
Efzofitimod 1 mg/kg
Concentrate for solution for infusion
Efzofitimod 3 mg/kg
Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
Efzofitimod 3 mg/kg
Concentrate for solution for infusion
Placebo
Participants will receive placebo matched to efzofitimod IV infusion on Day 1.
Placebo
Concentrate for solution for infusion
Interventions
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Efzofitimod 1 mg/kg
Concentrate for solution for infusion
Efzofitimod 3 mg/kg
Concentrate for solution for infusion
Placebo
Concentrate for solution for infusion
Eligibility Criteria
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Inclusion Criteria
* Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:
* Respiratory rate \>30 breaths/minute;
* Severe respiratory distress, as determined by the Investigator;
* Oxygen saturation (SpO2) ≤93% on room air.
Exclusion Criteria
* In the opinion of the Investigator, participant's progression to death is imminent.
* Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (TNF-α) inhibitors, anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to Day 1.
* Use of chronic (\>30 days) oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
* Weight \>165 kg or \<40 kg.
18 Years
75 Years
ALL
No
Sponsors
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aTyr Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
aTyr Investigative Site
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
aTyr Investigative Site
Vineland, New Jersey, United States
aTyr Investigative Site
Toledo, Ohio, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Alliance Medical Service, Cardio Pulmonary Research
Guaynabo, , Puerto Rico
Manati Medical Center
Manatí, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ATYR1923-C-003
Identifier Type: -
Identifier Source: org_study_id
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