Study to Evaluate the Safety and Efficacy of ATYR1923 In Patients With Severe Pneumonia Related to COVID-19
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
- SARS-CoV-2 (COVID-19) Severe Pneumonia
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be randomized 1:1:1 to a single IV dose of ATYR1923 1 mg/kg, ATYR1923 3 mg/kg, or placebo.
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The Investigator, Sponsor, and patient will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.
ATYR1923 1 mg/kg
|Single dose of ATYR1923 1 mg/kg||
ATYR1923 3 mg/kg
|Single dose of ATYR1923 3 mg/kg||
|Single dose of Placebo||
- Active, not recruiting
- aTyr Pharma, Inc.