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

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

ArmDescriptionAssigned Intervention
Experimental
Efzofitimod 1 mg/kg
Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1.
  • Drug: Efzofitimod 1 mg/kg
    Concentrate for solution for infusion
Experimental
Efzofitimod 3 mg/kg
Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
  • Drug: Efzofitimod 3 mg/kg
    Concentrate for solution for infusion
Placebo Comparator
Placebo
Participants will receive placebo matched to efzofitimod IV infusion on Day 1.
  • Drug: Placebo
    Concentrate for solution for infusion

More Details

Status
Completed
Sponsor
aTyr Pharma, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.