Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With CO… (NCT04615429) | Clinical Trial Compass
CompletedPhase 2
Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS
Spain20 participantsStarted 2020-09-15
Plain-language summary
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible.
✓. Adult patients ≥18 years of age at the time of enrolment.
✓. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigenic tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor.
✓. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
✓. Patients requiring invasive ventilation are eligible within 72 hours from intubation.
✓. Eligible for ICU admission, according to the clinical team.
Exclusion criteria
✕. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
✕. "Do Not Attempt Resuscitation" order in place.
✕. Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
✕. History of a moderate/severe lung disorder requiring home-based oxygen therapy.
What they're measuring
1
Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration