Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
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|ClinicalTrials.gov Identifier: NCT04615429|
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome COVID-19 Pneumonia||Biological: Mesenchymal stromal cells Other: Placebo||Phase 2|
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.
All trial participants will receive SOC*.
Randomization will be 1:1 between:
- Treatment arm: allogenic MSC.
Control arm: Placebo (solution with the same composition as the experimental treatment, without the MSC).
- SOC can include any medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind, Randomized, Controlled, Clinical Trial to Assess the Efficacy of Allogenic Mesenchymal Stromal Cells in Patients With Acute Respiratory Distress Syndrome Due to COVID-19|
|Actual Study Start Date :||September 15, 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Mesenchymal Stromal cells
Approximately 1x10E6 MSC/kg
Biological: Mesenchymal stromal cells
Administration of one single dose of allogenic Mesenchymal stromal cells
Placebo Comparator: Control group
Solution identical to experimental treatment, without the MSC
Administration of placebo (solution identical to experimental treatment, without the MSC)
- Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration [ Time Frame: 7 days ]Primary endpoint
- All-cause mortality [ Time Frame: Days 7, 14, and 28 after treatment ]Secondary endpoint
- Time to PaO2/FiO2 ratio greater than 200 mmHg [ Time Frame: 12 months ]Secondary endpoint
- Clinical status on the World Health Organization ordinal scale [ Time Frame: Baseline, daily until day 14, and on day 28 after treatment ]
- Not hospitalized, no limitations on activities.
- Not hospitalized, limitation on activities.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, on non-invasive ventilation or high flow oxygen devices.
- Hospitalized, on invasive mechanical ventilation or ECMO .
- PaO2/FiO2 ratio [ Time Frame: Baseline and days 2, 4, 14 and 28 after treatment ]Secondary endpoint
- SOFA score [ Time Frame: Baseline and days 2, 4, 7, 14 and 28 after treatment ]Secondary endpoint Sequential Organ Failure Assessment score (0-24)
- Oxygen therapy-free days [ Time Frame: Day 28 ]Secondary endpoint
- Duration of hospitalization [ Time Frame: 12 months ]Secondary endpoint
- Duration of ICU admission [ Time Frame: 12 months ]Secondary endpoint
- Incidence of non-invasive ventilation [ Time Frame: Day 28 ]Secondary endpoint Proportion of patients with non-invasive ventilation
- Incidence of invasive mechanical ventilation [ Time Frame: Day 28 ]Secondary endpoint Proportion of patients with invasive mechanical ventilation
- Duration of non-invasive ventilation [ Time Frame: Day 28 ]Secondary endpoint (number of days)
- Duration of invasive mechanical ventilation [ Time Frame: Day 28 ]Secondary endpoint (number of days)
- Mechanical ventilation-free days [ Time Frame: Day 28 ]Secondary endpoint
- Survival rate [ Time Frame: 3 and 12 months. ]Secondary endpoint
- Cumulative incidence SAEs, Grade 3 and 4 AEs, ADR and AEs of special interest. [ Time Frame: 12 months ]Secondary endpoint
- Analytical endpoints [ Time Frame: Baseline and days 2, 4, 7, 14 and 28 after treatment ]Exploratory endpoint Analytical markers (e.g., neutrophil and lymphocyte counts). Changes from baseline to set time points will be calculated.
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): NCT04615429
|Contact: Cristina Avendano-Sola, MD, PhDfirstname.lastname@example.org|
|Contact: Maria C Payares, MD, PhDemail@example.com|
|Hospital Universitario Puerta de Hierro-Majadahonda||Recruiting|
|Majadahonda, Madrid, Spain, 28222|
|Contact: Rafael F Duarte, MD, PhD +34911916662 firstname.lastname@example.org|
|Principal Investigator: Rafael F Duarte, MD, PhD|
|Principal Investigator: Juan J Rubio, MD, PhD|
|Principal Investigator: Rosa Malo, MD|
|Study Chair:||Rafael F Duarte, MD, PhD||Hematology Department. Hospital Universitario Puerta de Hierro|
|Study Chair:||Cristina Avedano-Sola, MD, PhD||Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro|
|Principal Investigator:||Juan J Rubio, MD, PhD||ICU. Hospital Universitario Puerta de Hierro|
|Principal Investigator:||Rosa Malo, MD||Respiratory Medicine Department|