Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19 (COVIDMES)
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|ClinicalTrials.gov Identifier: NCT04390139|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : July 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV 2 Adult Respiratory Distress Syndrome||Drug: XCEL-UMC-BETA Other: Placebo||Phase 1 Phase 2|
This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.
The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.
Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19|
|Actual Study Start Date :||May 13, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Treatment A
Wharton-Jelly mesenchymal stromal cells on D1 and D3
Administration on top of the standard administered treatment
Other Name: WJ-MSC
Placebo Comparator: Treatment B
Placebo on D1 and D3
Administration on top of the standard administered treatment
- All-cause mortality at day 28 [ Time Frame: Day 28 ]Number of patients who died, by treatment group
- Safety of WJ-MSC [ Time Frame: Day 28 ]Number of patients with treatment-emergent adverse events, by treatment group
- Need for treatment with rescue medication [ Time Frame: Day 28 ]Number of patients who, after the start of treatment, required rescue medication, by treatment group
- Need and duration of mechanical ventilation [ Time Frame: Day 28 ]Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28, by treatment group
- Ventilator free days [ Time Frame: Day 28 ]Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, per treatment group.
- Evolution of PaO2 / FiO2 ratio [ Time Frame: Day 28 ]Variation of the oxygenation index (PaO2 / FiO2) with respect to the baseline value, by treatment group.
- Evolution of the SOFA index [ Time Frame: Day 28 ]Variation of the score of the Sequential Organ Failure Assessment (SOFA) Index with respect to the baseline value, by treatment group.
- Evolution of the APACHE II score [ Time Frame: Day 28 ]Variation of Acute Physiology and Chronic Health disease Classification System II (APACHE II) score, by treatment group.
- Duration of hospitalization [ Time Frame: Day 28 ]Days of stay in the ICU from the day of admission until discharge to day 28, or date of death if earlier, by treatment group.
- Evolution of markers of immune response (leucocyte count, neutrophils) [ Time Frame: Day 28 ]Variation in the count and percentage of leukocytes and neutrophils, by treatment group.
- Feasibility of WJ-MSC administration [ Time Frame: Day 28 ]Feasibility will be evaluated by the time elapsed from the request of the treatment by the hospital center until the delivery date
- Feasibility of WJ-MSC administration [ Time Frame: Day 28 ]Feasibility will be evaluated by the number of patients treated within 2 days of the request for treatment.
- Evolution of disease biomarker: polymerase chain reaction (RT-PCR) [ Time Frame: Day 28 ]Variation in the values of the biomarker, by treatment group.
- Evolution of disease biomarker: lactate dehydrogenase (LDH) [ Time Frame: Day 28 ]Variation in the values of the biomarker, by treatment group.
- Evolution of disease biomarker: D-dimer [ Time Frame: Day 28 ]Variation in the values of the biomarker, by treatment group.
- Evolution of disease biomarker: Ferritin [ Time Frame: Day 28 ]Variation in the values of the biomarker, by treatment group.
- Analysis of subpopulations of lymphocytes and immunoglobulins [ Time Frame: Day 28 ]Blood sample analysis
- Evaluation of the in vitro response of the receptor lymphocytes [ Time Frame: Day 28 ]In vitro response will be assessed using commercial viral antigens (Miltenyi Biotech)
- Study of reactivity against SARS-CoV-2 peptides [ Time Frame: Day 28 ]Reactivity will be assessed using ELISPOT
- Immunophenotypic study of memory cells in response to SARS-CoV-2 peptides [ Time Frame: Day 28 ]Blood sample analysis
- Genetic variability of patient's genotype in response to treatment [ Time Frame: Day 28 ]Blood sample analysis for the patient's genomic sequencing
- Genetic variability of the SARS-CoV-2 genotype in response to treatment [ Time Frame: Day 28 ]Genomic sequencing of the SARS-CoV-2 in a nasopharyngeal sample
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390139
|Hospital de Bellvitge|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Mútua de Terrassa|
|Terrassa, Barcelona, Spain, 08221|
|Hospital del Mar|
|Barcelona, Spain, 08003|
|Hospital Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Clínic de Barcelona|
|Barcelona, Spain, 08036|
|Study Chair:||Antoni Torres, MD, PhD||Hospital Clinic of Barcelona|