Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19

Completed · Phase 2 · Has a placebo group

Conditions studied: SARS-CoV-2 (COVID-19) Severe Pneumonia

In brief

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 mechanical ventilation.

Key facts

Study ID

NCT04412668

Run by

aTyr Pharma, Inc.

People needed

36

Starts

2020-06-04

Expected to finish

2020-10-23

Last updated by the study team

2023-08-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — Manati, Puerto Rico

Full record on ClinicalTrials.gov

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