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Trial - NCT04865107


Column Value
Trial registration number NCT04865107
Full text link
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04865107

First author
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Duncan J Stewart, MD

Contact
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

djstewart@ohri.ca

Registration date
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

2021-04-29

Recruitment status
Last imported at : May 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

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
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

- 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)

Number of arms
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Ottawa Hospital Research Institute

Inclusion age min
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

54

primary outcome
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Number of days free of oxygen by NIV/HFNC or mechanical ventilation at Day 28

Notes
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : April 30, 2021, 7:54 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]