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Trial record 1 of 1 for:    SAIL-004
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Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT04321993
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : July 24, 2020
Sponsor:
Collaborators:
Nova Scotia Health Authority
Dalhousie University
Information provided by (Responsible Party):
Lisa Barrett, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE March 24, 2020
First Posted Date  ICMJE March 26, 2020
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE April 17, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
Clinical status of subject at day 15 (on a 7 point ordinal scale). [ Time Frame: Up to 15 days ]
  1. Not hospitalized, no limitations on activities
  2. Not hospitalized, limitation on activities;
  3. Hospitalized, not requiring supplemental oxygen;
  4. Hospitalized, requiring supplemental oxygen;
  5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
  6. Hospitalized, on invasive mechanical ventilation or ECMO;
  7. Death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180. [ Time Frame: Up to 180 days ]
    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or ECMO;
    7. Death.
  • Length of time to clinical improvement [ Time Frame: Up to 29 days ]
    Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.
  • Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29 [ Time Frame: Up to 29 days ]
  • Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment [ Time Frame: Up to 24 weeks ]
  • Length of time to clinical progression [ Time Frame: Up to 29 days ]
    Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission
  • Cause of death (if applicable) [ Time Frame: Up to 24 weeks ]
  • Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean) [ Time Frame: Up to 29 days ]
  • Length of time to normalization of fever [ Time Frame: Up to 29 days ]
    Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours
  • Length of time to normalization of oxygen saturation [ Time Frame: Up to 29 days ]
    Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.
  • Duration of supplemental oxygen (if applicable) [ Time Frame: Up to 29 days ]
  • Duration of mechanical ventilation (if applicable) [ Time Frame: Up to 29 days ]
  • Duration of hospitalization [ Time Frame: Up to 29 days ]
  • Adverse events [ Time Frame: Up to 180 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2020)
  • Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm [ Time Frame: Up to 180 days ]
  • Percent of subjects with SARS-CoV-2 detectable in blood at days 3, 5, 8, 11, 15, 29 and 180. [ Time Frame: Up to 180 days ]
  • Quantitative SARS-CoV-2 viral load in blood at days 3, 5, 8, and 11, 15, 29, and 180. [ Time Frame: Up to 180 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Official Title  ICMJE Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Brief Summary Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Baricitinib (janus kinase inhibitor)
Baricitinib 2 mg po daily for 10 days
Study Arms  ICMJE
  • Experimental: Baricitinib
    Intervention: Drug: Baricitinib (janus kinase inhibitor)
  • No Intervention: Clinical standard of care
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2020)
800
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
1000
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Moderate to severe COVID-19 associated disease as defined by the WHO
  • Hospitalized patient
  • Willing and able to provide written informed consent prior to performing study procedures
  • Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay
  • Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen.
  • Febrile defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal documented within 48 hours of consent

Exclusion Criteria:

  • Participation in any other clinical trial of an experimental treatment for COVID-19
  • Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation
  • SOFA >10
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
  • Pregnant women or women who are breastfeeding
  • Immunocompromised patients taking medication upon screening
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barbara Goodall (902) 292-0132 barbara.goodall@nshealth.ca
Contact: Lisa Barrett (902) 473-6446 lisa.barrett@nshealth.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04321993
Other Study ID Numbers  ICMJE SAIL-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Barrett, Nova Scotia Health Authority
Study Sponsor  ICMJE Lisa Barrett
Collaborators  ICMJE
  • Nova Scotia Health Authority
  • Dalhousie University
Investigators  ICMJE Not Provided
PRS Account Nova Scotia Health Authority
Verification Date July 2020

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