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

• ClinicalTrials.gov Identifier: NCT04412668
• Recruitment Status: Recruiting
• First Posted: June 2, 2020
• Last Update Posted: June 18, 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: October 31, 2020
• Estimated Study Completion Date: October 31, 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 normalization of oxygen saturation (SpO2) (>93% on room air sustained for at least 24 hours) [ Time Frame: Baseline through Day 14 or discharge ]
2. Duration of supplemental oxygen (O2) requirement [ Time Frame: Baseline through Day 14 or discharge ]
3. Number of days with fever (temperature >100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
4. Time to normalization of temperature (≤100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
5. 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 ]
6. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 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;
  • 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.

Contacts and Locations

Contacts

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

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Contact: Steve Duncan, MD 205-934-5018 srduncan@uabmc.edu

Principal Investigator: Steve Duncan, MD

United States, District of Columbia

aTyr Investigative Site; Recruiting

Washington, District of Columbia, United States, 20010

Contact clinicaltrials@atyrpharma.com

United States, Iowa

University of Iowa; Recruiting

Iowa City, Iowa, United States, 52242

Contact: Alejandro Comellas, MD 319-353-8862 alejandro-comellas@uiowa.edu

Principal Investigator: Alejandro Comellas, MD

United States, New Jersey

aTyr Investigative Site; Recruiting

Vineland, New Jersey, United States, 08360

Contact clinicaltrials@atyrpharma.com

United States, Virginia

Inova Fairfax Medical Campus; Recruiting

Falls Church, Virginia, United States, 22042

Contact: Shambhu Aryal, MD shambhu.aryal@inova.org

Principal Investigator: Shambhu Aryal, MD

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: June 18, 2020
• Last Verified: June 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