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Trial record 2 of 2 for:    Covid | Immunotherapy | Canada

Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial (CIRCA-19 RCT)

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ClinicalTrials.gov Identifier: NCT04865107
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE April 27, 2021
First Posted Date  ICMJE April 29, 2021
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE April 27, 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
Number of days free of oxygen by NIV/HFNC or mechanical ventilation at Day 28 [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
  • Biomarkers of systemic inflammatory response [ Time Frame: Change from Baseline to 24 hours after each MSC infusion ]
    Interleukin levels change from Baseline to 24 hours after each MSC infusion
  • Biomarkers of endothelial function [ Time Frame: Change from Baseline to 24 hours after each MSC infusion ]
    Angiopoietin levels change from Baseline to 24 hours after each MSC infusion
  • ICU mortality [ Time Frame: Day 28 ]
    Number of deaths at day 28
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2021)
Safety events (SAEs, AEs) [ Time Frame: At time of infusion until one year post-infusion ]
allergic reactions, infusion related reactions, and venous and arterial thrombotic events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
Official Title  ICMJE Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
Brief Summary

This is a Phase 2 multicenter randomized (2:1), placebo-controlled trial to evaluate early signs of efficacy of allogeneic, umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in patients with COVID-19 and Acute Respiratory Distress Syndrome (ARDS).

Randomized participants (N=54) will receive 3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs) or blinded placebo. The MSC product will be provided as 2.5 million cells/ml suspended in PlasmaLyte A containing 5% Human Albumin. The appearance-matched placebo product contains the same excipients, PlasmaLyte A and 5% Human Albumin, as the UC-MSCs.

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:
Randomized (2:1) placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Biological: UC-MSCs
    3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
  • Biological: Placebo
    PlasmaLyte A and 5% Human Albumin
Study Arms  ICMJE
  • Experimental: MSCs Arm
    3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
    Intervention: Biological: UC-MSCs
  • Placebo Comparator: Placebo Arm
    3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
    Intervention: Biological: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2021)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age of ≥18 years
  • Laboratory-confirmed SARS-CoV-2 infection during the current admission
  • On invasive, non-invasive mechanical ventilation (NIV) (PEEP ≥5 cmH20) or high-flow nasal canula (HFNC) oxygen therapy (minimum total flow rate of 40 lpm)
  • ARDS (onset <96h) as per the international consensus definition (P/F ratio < 300 with PEEP ≥5cm H20 or on HFNC), not due primarily to cardiac causes.

Exclusion Criteria:

  • No consent/inability to obtain consent
  • Rockwood Clinical Frailty Score > 4
  • Moribund patient not expected to survive 24 hours
  • Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  • Currently receiving extracorporeal life support
  • Pregnant or lactating
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Moderate to severe chronic liver disease (Childs-Pugh Score > 12)
  • Severe chronic respiratory disease with a baseline PaCO2 > 50 mm Hg or the use of home oxygen
  • Documented deep venous thrombosis or pulmonary embolism within the preceding 3 months
  • Inability/contra-indications to receiving local standard of care thromboprophylaxis
  • Chronic immunosuppression (any chronic immunotherapy including daily oral steroid use >6months)
  • Known HIV, Hep B/C positive, or active tuberculosis
  • Multisystem shock (SOFA score change from baseline of >2 in >2 systems)
  • Patient, surrogate, or physician not committed to full support including intubation (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
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: Duncan J Stewart, MD 613-798-5555 ext 7917 djstewart@ohri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04865107
Other Study ID Numbers  ICMJE CIRCA-19 RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Duncan J Stewart, MD The Ottawa Hospital
PRS Account Ottawa Hospital Research Institute
Verification Date May 2021

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