Study to Evaluate the Safety and Efficacy of ATYR1923 In Patients With Severe Pneumonia Related to COVID-19

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    aTyr Pharma, Inc.
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Updated on 16 February 2024
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Summary

A Phase 2 study to evaluate the safety and preliminary efficacy of ATYR1923, compared to placebo, in hospitalized patients with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation

Details
Condition SARS-CoV-2 (COVID-19) Severe Pneumonia
Age 18years - 70years
Treatment Placebo, ATYR1923 1 mg/kg, ATYR1923 3 mg/kg
Clinical Study IdentifierNCT04412668
SponsoraTyr Pharma, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Confirmation of SARS-CoV2 infection by PCR
Severe pneumonia related to SARS-CoV2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least one of the following
Respiratory rate >30 breaths/min; or
Severe respiratory distress, as determined by the Investigator; or
SpO2 93% on room air

Exclusion Criteria

Requires intubation
In the opinion of the Investigator, patient unlikely to survive for >48 hours from Screening
Treatment with immunosuppressant/immunotherapy drugs, including but not limited to IL-6 inhibitors, TNF- 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
Body mass index >40 kg/m2 or weight >160 kg or <40 kg
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