Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
SARS-CoV-2 (COVID-19) Severe Pneumonia
About this trial
This is an interventional treatment trial for SARS-CoV-2 (COVID-19) Severe Pneumonia focused on measuring SARS-CoV-2, CoV-2, ATYR1923 (efzofitimod), acute respiratory distress syndrome, ARDS, SARS-CoV-2 Infection, COVID-19, Severe Pneumonia
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham
- aTyr Investigative Site
- University of Miami
- University of Iowa
- Anne Arundel Medical Center
- aTyr Investigative Site
- aTyr Investigative Site
- Inova Fairfax Medical Campus
- Alliance Medical Service, Cardio Pulmonary Research
- Manati Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Efzofitimod 1 mg/kg
Efzofitimod 3 mg/kg
Placebo
Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1.
Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
Participants will receive placebo matched to efzofitimod IV infusion on Day 1.