Phase 2
N=36
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
Bottom Line
View on ClinicalTrials.gov: NCT04412668 ↗Enrolled (actual)
36
Serious AEs
15.6%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 8; 7; 7; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Efzofitimod 1 mg/kg (Drug); Efzofitimod 3 mg/kg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- aTyr Pharma, Inc.
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
8; 7; 7; 5; 0; 0 | — |
| SECONDARY Time to Hospital Discharge |
7.0; 5.5; 4.5 | — |
| SECONDARY Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3) |
7.0; 5.5; 4.5 | — |
| SECONDARY Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28 |
4; 9; 7; 5; 11; 9 | — |
| SECONDARY Number of Days With Supplemental Oxygen (O2) |
10.4; 13.7; 10.1 | — |
| SECONDARY Number of Days With Fever (Temperature >100.4ºF [38.0ºC]) |
0.1; 0.1; 0.0 | — |
| SECONDARY Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score |
5.0; 4.0; 3.0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04412668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.