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
Drug: ATYR1923 1 mg/kg
1 mg/kg of ATYR1923 administered intravenously
Drug: ATYR1923 3 mg/kg
3 mg/kg of ATYR1923 administered intravenously
Drug: Placebo
Placebo administered intravenously
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
aTyr Investigative Site
Washington, 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
Manatí, Puerto Rico
Gennyne Walker, Study Director
aTyr Pharma, Inc.