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

NCT04412668 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ATYR1923-C-003
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

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

Keywords

SARS-CoV-2; CoV-2; ATYR1923 (efzofitimod); acute respiratory distress syndrome; ARDS; SARS-CoV-2 Infection; COVID-19; Severe Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.

  Baseline up to Day 60

Secondary Outcomes (7)

• Time to Hospital Discharge

  Baseline up to Day 60

• Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3)

  Baseline up to Day 60

• Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28

  Baseline through Day 14 and Day 28

• Number of Days With Supplemental Oxygen (O2)

  Baseline up to Day 60

• Number of Days With Fever (Temperature >100.4ºF [38.0ºC])

  Baseline up to Day 14

Study Arms (3)

Efzofitimod 1 mg/kg

EXPERIMENTAL

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

Drug: Efzofitimod 1 mg/kg

Efzofitimod 3 mg/kg

EXPERIMENTAL

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

Drug: Efzofitimod 3 mg/kg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Efzofitimod 1 mg/kg DRUG

Concentrate for solution for infusion

Efzofitimod 1 mg/kg

Efzofitimod 3 mg/kg DRUG

Concentrate for solution for infusion

Efzofitimod 3 mg/kg

Placebo DRUG

Concentrate for solution for infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• aTyr Pharma, Inc.: lead

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

aTyr Investigative Site

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

aTyr Investigative Site

Vineland, New Jersey, 08360, United States

Location

aTyr Investigative Site

Toledo, Ohio, 43614, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Alliance Medical Service, Cardio Pulmonary Research

Guaynabo, 00968, Puerto Rico

Location

Manati Medical Center

Manatí, 00674, Puerto Rico

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Study Director
• Organization: aTyR Pharma

clinicaltrials@atyrpharma.com

858 731 8389

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator, Sponsor, and participant will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 2, 2020
• Study Start: June 4, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: August 18, 2023
• Results First Posted: August 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2); US (8)