Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
NCT ID: NCT04865107
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2021-04-27
2022-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MSCs Arm
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
UC-MSCs
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
Placebo Arm
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
Placebo
PlasmaLyte A and 5% Human Albumin
Interventions
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UC-MSCs
3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
Placebo
PlasmaLyte A and 5% Human Albumin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Duncan J Stewart, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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Lakeridge Health
Oshawa, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CIRCA-19 RCT
Identifier Type: -
Identifier Source: org_study_id
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