Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stem Cells (NCT04361942) | Clinical Trial Compass
CompletedPhase 2
Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stem Cells
Spain24 participantsStarted 2020-05-01
Plain-language summary
Novel coronavirus disease COVID-19, produced by SARS-CoV-2, has become a health emergency around the world. Since first patients were detected in Wuhan (China), in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem/stromal cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the double-blind, placebo-controlled, randomized, phase I/II clinical trial to evaluate safety and efficacy of allogeneic MSCs for treatment of severe COVID-19 pneumonia.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women or men of ≥ 18 years of age
✓. SARS-CoV-2 infection confirmed by molecular testing.
✓. Admitted to the Intensive Care Unit with pneumonia by COVID-19 infection and intubated in the last 48 hours, that meet at least one of these criteria:
✓. Respiratory distress.
✓. Respiratory rate (RR) ≥ 30 rpm.
✓. Basal oxygen saturation at rest ≤ 93%.
✓. Arterial partial pressure of oxygen (PaO2) / inspiratory fraction of oxygen (FiO2) ≤ 300 mmHg.
✓. Consent of the patient or his/her legal representative for participation in the study.
Exclusion criteria
✕. Active tumor disease.
✕. Pregnancy.
✕. Participation in another active clinical trial.
What they're measuring
1
Proportion of patients in whom removal of invasive mechanical ventilation (IMV) has been achieved