Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- COVID 19 Pneumonia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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: Treatme...
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.).
Tracking Information
- NCT #
- NCT04615429
- Collaborators
- Not Provided
- Investigators
- 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
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