Clinical trial NCT04412668: Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Official title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of ATYR1923 In Adult Patients With Severe Pneumonia Related to SARS-CoV-2 Infection (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: aTyr Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 60
Secondary outcomes:
measure: Time to Hospital Discharge
timeFrame: Baseline up to Day 60
measure: Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3)
timeFrame: Baseline up to Day 60
measure: Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28
timeFrame: Baseline through Day 14 and Day 28
measure: Number of Days With Supplemental Oxygen (O2)
timeFrame: Baseline up to Day 60
measure: Number of Days With Fever (Temperature >100.4ºF [38.0ºC])
timeFrame: Baseline up to Day 14
measure: Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
timeFrame: Baseline, Day 60
measure: Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score
timeFrame: Baseline up to Day 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Washington
country: United States
facility: aTyr Investigative Site
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Vineland
country: United States
facility: aTyr Investigative Site
state: New Jersey
city: Toledo
country: United States
facility: aTyr Investigative Site
state: Ohio
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Guaynabo
country: Puerto Rico
facility: Alliance Medical Service, Cardio Pulmonary Research
city: Manatí
country: Puerto Rico
facility: Manati Medical Center
Study officials:
References: