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)
Brief Summary

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

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

Drug: ATYR1923 1 mg/kg

1 mg/kg of ATYR1923 administered intravenously

Drug: ATYR1923 3 mg/kg

3 mg/kg of ATYR1923 administered intravenously

Drug: Placebo

Placebo administered intravenously

Eligibility Criteria

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;

- Oxygen saturation (SpO2) ≤93% on room air.

Exclusion Criteria:

- Patient is intubated/mechanically ventilated.

- In the opinion of the Investigator, patient's progression to death is imminent.

- 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.

- Weight >165 kg or <40 kg.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Puerto Rico
United States
Locations

University of Alabama at Birmingham
Birmingham, Alabama, United States

aTyr Investigative Site
Washington, District of Columbia, United States

University of Miami
Miami, Florida, United States

University of Iowa
Iowa City, Iowa, United States

Anne Arundel Medical Center
Annapolis, Maryland, United States

aTyr Investigative Site
Vineland, New Jersey, United States

aTyr Investigative Site
Toledo, Ohio, United States

Inova Fairfax Medical Campus
Falls Church, Virginia, United States

Alliance Medical Service, Cardio Pulmonary Research
Guaynabo, Puerto Rico

Manati Medical Center
Manatí, Puerto Rico

Gennyne Walker, Study Director
aTyr Pharma, Inc.

aTyr Pharma, Inc.
NCT Number
Keywords
SARS-CoV-2
CoV-2
ATYR1923
Acute Respiratory Distress Syndrome
ARDS
SARS-CoV-2 infection
Covid-19
severe pneumonia
MeSH Terms
COVID-19
Pneumonia