Study to Evaluate the Safety and Efficacy of ATYR1923 In Patients With Severe Pneumonia Related to COVID-19

• ClinicalTrials.gov Identifier: NCT04412668
• Recruitment Status: Active, not recruiting
• First Posted: June 2, 2020
• Last Update Posted: November 19, 2020
• Sponsor: aTyr Pharma, Inc.
• Information provided by (Responsible Party): aTyr Pharma, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2 (COVID-19) Severe Pneumonia	Drug: ATYR1923 1 mg/kg; Drug: ATYR1923 3 mg/kg; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• 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.
• 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.
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: June 12, 2020
• Estimated Primary Completion Date: December 21, 2020
• Estimated Study Completion Date: December 21, 2020

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline through Day 60 ]

Secondary Outcome Measures :

1. Time to hospital discharge [ Time Frame: Baseline through Day 60 ]
2. Time to recovery (World Health Organization [WHO] Ordinal Scale score ≤3) [ Time Frame: Baseline through Day 60 ]
3. Proportion of patients achieving recovery by Day 14 and Day 28 [ Time Frame: Baseline through Day 14 and Day 28 ]
4. Duration of supplemental oxygen (O2) requirement [ Time Frame: Baseline through Day 60 ]
5. Number of days with fever (temperature >100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
6. Change from baseline in World Health Organization (WHO) Ordinal Scale score on Days 5, 7, 14, 28, and 60 [ Time Frame: Baseline through Day 60 ]
7. Time to improvement from inpatient hospital admission based on at least a 1 point reduction in WHO Ordinal Scale score [ Time Frame: Baseline through Day 60 ]
8. All-cause mortality at Days 14, 28, and 60 [ Time Frame: Baseline through Day 60 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, District of Columbia

aTyr Investigative Site

Washington, District of Columbia, United States, 20010

United States, Florida

University of Miami

Miami, Florida, United States, 33125

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Maryland

Anne Arundel Medical Center

Annapolis, Maryland, United States, 21401

United States, New Jersey

aTyr Investigative Site

Vineland, New Jersey, United States, 08360

United States, Ohio

aTyr Investigative Site

Toledo, Ohio, United States, 43614

United States, Virginia

Inova Fairfax Medical Campus

Falls Church, Virginia, United States, 22042

Puerto Rico

Alliance Medical Service, Cardio Pulmonary Research

Guaynabo, Puerto Rico, 00968

Manati Medical Center

Manatí, Puerto Rico, 00674

Sponsors and Collaborators

aTyr Pharma, Inc.

Investigators

• Study Director: Gennyne Walker; aTyr Pharma, Inc.

More Information

• Responsible Party: aTyr Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT04412668
• Other Study ID Numbers: ATYR1923-C-003
• First Posted: June 2, 2020
• Last Update Posted: November 19, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by aTyr Pharma, Inc.:

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

Additional relevant MeSH terms:

Pneumonia; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections