Status:
COMPLETED
Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Stem Cell Network
Ontario Research Fund
Conditions:
Acute Respiratory Distress Syndrome
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission ...
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 on fraction of inspired oxygen (FiO2)≥0.5, with PEEP ≥5cm H2O or on HFNC), not due to cardiac causes.
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this trial:
- No consent/inability to obtain consent
- 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
- Lung transplant patient
- Documented deep venous thrombosis or pulmonary embolism within the past 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 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 :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04400032
Start Date
May 15 2020
End Date
April 22 2021
Last Update
April 26 2021
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6