Purpose

A Phase 2 study to evaluate the safety and preliminary efficacy of ATYR1923, compared to placebo, in hospitalized patients with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmation of SARS-CoV2 infection by PCR.
  • Severe pneumonia related to SARS-CoV2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least one of the following:
  • Respiratory rate >30 breaths/min; or
  • Severe respiratory distress, as determined by the Investigator; or;
  • SpO2 ≤93% on room air.

Exclusion Criteria

  • Requires intubation.
  • In the opinion of the Investigator, patient unlikely to survive for >48 hours from Screening.
  • Treatment with immunosuppressant/immunotherapy drugs, including but not limited to IL-6 inhibitors, 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.
  • Body mass index >40 kg/m2 or weight >160 kg or <40 kg.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Patients will be randomized 1:1:1 to a single IV dose of ATYR1923 1 mg/kg, ATYR1923 3 mg/kg, or placebo.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The Investigator, Sponsor, and patient will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ATYR1923 1 mg/kg
Single dose of ATYR1923 1 mg/kg
  • Drug: ATYR1923 1 mg/kg
    1 mg/kg of ATYR1923 administered intravenously
Experimental
ATYR1923 3 mg/kg
Single dose of ATYR1923 3 mg/kg
  • Drug: ATYR1923 3 mg/kg
    3 mg/kg of ATYR1923 administered intravenously
Placebo Comparator
Placebo
Single dose of Placebo
  • Drug: Placebo
    Placebo administered intravenously

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Steve Duncan, MD
205-934-5018
srduncan@uabmc.edu

More Details

Status
Recruiting
Sponsor
aTyr Pharma, Inc.

Study Contact

aTyr Pharma Clinical Research
877-215-5731
clinicaltrials@atyrpharma.com

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.