Status:
COMPLETED
Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Covid19
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04865107
Start Date
April 27 2021
End Date
April 1 2022
Last Update
July 31 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Lakeridge Health
Oshawa, Ontario, Canada, ON L1G 2B9
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
3
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
4
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4