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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412668
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
aTyr Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2020
First Posted Date  ICMJE June 2, 2020
Last Update Posted Date January 29, 2021
Actual Study Start Date  ICMJE June 12, 2020
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline through Day 60 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • Time to hospital discharge [ Time Frame: Baseline through Day 60 ]
  • Time to recovery (World Health Organization [WHO] Ordinal Scale score ≤3) [ Time Frame: Baseline through Day 60 ]
  • Proportion of patients achieving recovery by Day 14 and Day 28 [ Time Frame: Baseline through Day 14 and Day 28 ]
  • Duration of supplemental oxygen (O2) requirement [ Time Frame: Baseline through Day 60 ]
  • Number of days with fever (temperature >100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
  • 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 ]
  • 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 ]
  • All-cause mortality at Days 14, 28, and 60 [ Time Frame: Baseline through Day 60 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
  • 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 ]
  • Duration of supplemental oxygen (O2) requirement [ Time Frame: Baseline through Day 14 or discharge ]
  • Number of days with fever (temperature >100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
  • Time to normalization of temperature (≤100.4ºF [38.0ºC]) [ Time Frame: Baseline through Day 14 or discharge ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of ATYR1923 In Patients With Severe Pneumonia Related to COVID-19
Official Title  ICMJE 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE SARS-CoV-2 (COVID-19) Severe Pneumonia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: ATYR1923 1 mg/kg
    Single dose of ATYR1923 1 mg/kg
    Intervention: Drug: ATYR1923 1 mg/kg
  • Experimental: ATYR1923 3 mg/kg
    Single dose of ATYR1923 3 mg/kg
    Intervention: Drug: ATYR1923 3 mg/kg
  • Placebo Comparator: Placebo
    Single dose of Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2021)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2020)
30
Actual Study Completion Date  ICMJE December 21, 2020
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04412668
Other Study ID Numbers  ICMJE ATYR1923-C-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party aTyr Pharma, Inc.
Study Sponsor  ICMJE aTyr Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gennyne Walker aTyr Pharma, Inc.
PRS Account aTyr Pharma, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP