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

• Status: Completed
• Trial end date: 2020-12-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: aTyr Pharma, Inc.

Criteria

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;

• Oxygen saturation (SpO2) ≤93% on room air.

Exclusion Criteria:

• Patient is intubated/mechanically ventilated.

• In the opinion of the Investigator, patient's progression to death is imminent.

• Treatment with immunosuppressant/immunotherapy drugs, including but not limited to IL-6 inhibitors, 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.