Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Purpose
To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
Condition
- SARS-CoV-2 (COVID-19) Severe Pneumonia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR). - Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following: - Respiratory rate >30 breaths/minute; - Severe respiratory distress, as determined by the Investigator; - Oxygen saturation (SpO2) ≤93% on room air.
Exclusion Criteria
- Participant is intubated/mechanically ventilated. - In the opinion of the Investigator, participant's progression to death is imminent. - Treatment with immunosuppressant/immunotherapy drugs, including but not limited to interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized 1:1:1 to a single intravenous (IV) dose of efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, or placebo matched to efzofitimod.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The Investigator, Sponsor, and participant will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Efzofitimod 1 mg/kg |
Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1. |
|
|
Experimental Efzofitimod 3 mg/kg |
Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to efzofitimod IV infusion on Day 1. |
|
More Details
- Status
- Completed
- Sponsor
- aTyr Pharma, Inc.