Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19

aTyr Pharma

Status and phase: Completed; Phase 2

Conditions: SARS-CoV-2 (COVID-19) Severe Pneumonia

Treatments: Drug: Efzofitimod 1 mg/kg; Drug: Placebo; Drug: Efzofitimod 3 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04412668

ATYR1923-C-003

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Efzofitimod 1 mg/kg

Experimental group

Description:

Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1.

Treatment:

Drug: Efzofitimod 1 mg/kg

Efzofitimod 3 mg/kg

Experimental group

Description:

Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1.

Treatment:

Drug: Efzofitimod 3 mg/kg

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to efzofitimod IV infusion on Day 1.

Treatment:

Drug: Placebo