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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

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.


Condition or disease Intervention/treatment Phase
Covid19 Acute Respiratory Distress Syndrome Biological: UC-MSCs Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
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
Official Title: Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: MSCs Arm
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
Biological: UC-MSCs
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million 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)
Biological: Placebo
PlasmaLyte A and 5% Human Albumin




Primary Outcome Measures :
  1. Number of days free of oxygen by NIV/HFNC or mechanical ventilation at Day 28 [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. ICU mortality [ Time Frame: Day 28 ]
    Number of deaths at day 28


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT04865107


Contacts
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Contact: Duncan J Stewart, MD 613-798-5555 ext 7917 djstewart@ohri.ca

Locations
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Canada, Ontario
Lakeridge Health Recruiting
Oshawa, Ontario, Canada, ON L1G 2B9
Contact: Karim Soliman, MD       ksoliman@lh.ca   
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Duncan J Stewart, MD    +1 613-737-8899 ext 75083    djstewart@toh.ca   
Sub-Investigator: Shane English, MD         
Sub-Investigator: Dean Fergusson, PhD         
Sub-Investigator: Manoj Lalu, MD         
Sub-Investigator: Bernard Thebaud, MD         
Sub-Investigator: David Courtman, PhD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Claudia Dos Santos, MD       Claudia.DosSantos@unityhealth.to   
Sub-Investigator: Kim Connelly, MD         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Not yet recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: Michaël Chassé, MD       michael.chasse@umontreal.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Duncan J Stewart, MD The Ottawa Hospital
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04865107    
Other Study ID Numbers: CIRCA-19 RCT
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury