Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Lead Sponsor:
aTyr Pharma, Inc.
Conditions:
SARS-CoV-2 (COVID-19) Severe Pneumonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mecha...
Eligibility Criteria
Inclusion
- Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
- 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
- Participant is intubated/mechanically ventilated.
- 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.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04412668
Start Date
June 4 2020
End Date
October 23 2020
Last Update
August 18 2023
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
aTyr Investigative Site
Washington D.C., District of Columbia, United States, 20010
3
University of Miami
Miami, Florida, United States, 33125
4
University of Iowa
Iowa City, Iowa, United States, 52242