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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412668
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
aTyr Pharma, Inc.

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

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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


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




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412668


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

Locations
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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
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Study Director: Gennyne Walker aTyr Pharma, Inc.
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Responsible Party: aTyr Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04412668    
Other Study ID Numbers: ATYR1923-C-003
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections