Back to resultsClinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
Primary Purpose
Acute Respiratory Distress Syndrome, COVID-19 Pneumonia
Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Mesenchymal stromal cells
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, Mesenchymal stromal cells, Coronavirus, SARS-CoV-2
Eligibility Criteria
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.
- Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
- Current diagnosis of pulmonary embolism.
- Active neoplasm, except carcinoma in situ or basalioma.
- Known allergy to the products involved in the allogenic MSC production process.
- Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
- Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
- Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.
Sites / Locations
- Hospital Universitario Puerta de Hierro-MajadahondaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mesenchymal Stromal cells
Control group
Arm Description
Approximately 1x10E6 MSC/kg
Solution identical to experimental treatment, without the MSC
Outcomes
Primary Outcome Measures
Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration
Primary endpoint
Secondary Outcome Measures
All-cause mortality
Secondary endpoint
Time to PaO2/FiO2 ratio greater than 200 mmHg
Secondary endpoint
Clinical status on the World Health Organization ordinal scale
Secondary endpoint.
Categories:
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 .
Death.
PaO2/FiO2 ratio
Secondary endpoint
SOFA score
Secondary endpoint Sequential Organ Failure Assessment score (0-24)
Oxygen therapy-free days
Secondary endpoint
Duration of hospitalization
Secondary endpoint
Duration of ICU admission
Secondary endpoint
Incidence of non-invasive ventilation
Secondary endpoint Proportion of patients with non-invasive ventilation
Incidence of invasive mechanical ventilation
Secondary endpoint Proportion of patients with invasive mechanical ventilation
Duration of non-invasive ventilation
Secondary endpoint (number of days)
Duration of invasive mechanical ventilation
Secondary endpoint (number of days)
Mechanical ventilation-free days
Secondary endpoint
Survival rate
Secondary endpoint
Cumulative incidence SAEs, Grade 3 and 4 AEs, ADR and AEs of special interest.
Secondary endpoint
Full Information
NCT ID
NCT04615429
First Posted
October 25, 2020
Last Updated
November 9, 2021
Sponsor
Cristina Avendaño Solá
1. Study Identification
Unique Protocol Identification Number
NCT04615429
Brief Title
Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Avendaño Solá
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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:
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, COVID-19 Pneumonia
Keywords
Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, Mesenchymal stromal cells, Coronavirus, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal Stromal cells
Arm Type
Experimental
Arm Description
Approximately 1x10E6 MSC/kg
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Solution identical to experimental treatment, without the MSC
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stromal cells
Intervention Description
Administration of one single dose of allogenic Mesenchymal stromal cells
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administration of placebo (solution identical to experimental treatment, without the MSC)
Primary Outcome Measure Information:
Title
Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration
Description
Primary endpoint
Time Frame
7 days
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Secondary endpoint
Time Frame
Days 7, 14, and 28 after treatment
Title
Time to PaO2/FiO2 ratio greater than 200 mmHg
Description
Secondary endpoint
Time Frame
12 months
Title
Clinical status on the World Health Organization ordinal scale
Description
Secondary endpoint.
Categories:
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 .
Death.
Time Frame
Baseline, daily until day 14, and on day 28 after treatment
Title
PaO2/FiO2 ratio
Description
Secondary endpoint
Time Frame
Baseline and days 2, 4, 14 and 28 after treatment
Title
SOFA score
Description
Secondary endpoint Sequential Organ Failure Assessment score (0-24)
Time Frame
Baseline and days 2, 4, 7, 14 and 28 after treatment
Title
Oxygen therapy-free days
Description
Secondary endpoint
Time Frame
Day 28
Title
Duration of hospitalization
Description
Secondary endpoint
Time Frame
12 months
Title
Duration of ICU admission
Description
Secondary endpoint
Time Frame
12 months
Title
Incidence of non-invasive ventilation
Description
Secondary endpoint Proportion of patients with non-invasive ventilation
Time Frame
Day 28
Title
Incidence of invasive mechanical ventilation
Description
Secondary endpoint Proportion of patients with invasive mechanical ventilation
Time Frame
Day 28
Title
Duration of non-invasive ventilation
Description
Secondary endpoint (number of days)
Time Frame
Day 28
Title
Duration of invasive mechanical ventilation
Description
Secondary endpoint (number of days)
Time Frame
Day 28
Title
Mechanical ventilation-free days
Description
Secondary endpoint
Time Frame
Day 28
Title
Survival rate
Description
Secondary endpoint
Time Frame
3 and 12 months.
Title
Cumulative incidence SAEs, Grade 3 and 4 AEs, ADR and AEs of special interest.
Description
Secondary endpoint
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Analytical endpoints
Description
Exploratory endpoint Analytical markers (e.g., neutrophil and lymphocyte counts). Changes from baseline to set time points will be calculated.
Time Frame
Baseline and days 2, 4, 7, 14 and 28 after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
Current diagnosis of pulmonary embolism.
Active neoplasm, except carcinoma in situ or basalioma.
Known allergy to the products involved in the allogenic MSC production process.
Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Avendano-Sola, MD, PhD
Phone
+34911916479
Email
cavendano@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maria C Payares, MD, PhD
Email
concepcion.payares@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael F Duarte, MD, PhD
Organizational Affiliation
Hematology Department. Hospital Universitario Puerta de Hierro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina Avedano-Sola, MD, PhD
Organizational Affiliation
Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juan J Rubio, MD, PhD
Organizational Affiliation
ICU. Hospital Universitario Puerta de Hierro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa Malo, MD
Organizational Affiliation
Respiratory Medicine Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro-Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael F Duarte, MD, PhD
Phone
+34911916662
Email
rduarte.work@gmail.com
First Name & Middle Initial & Last Name & Degree
Rafael F Duarte, MD, PhD
First Name & Middle Initial & Last Name & Degree
Juan J Rubio, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rosa Malo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33407777
Citation
Payares-Herrera C, Martinez-Munoz ME, Vallhonrat IL, de Molina RM, Torres MP, Trisan A, de Diego IS, Alonso R, Zafra R, Donaire T, Sanchez R, Rubio JJ, Duarte Palomino RF, Sola CA. Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 6;22(1):9. doi: 10.1186/s13063-020-04964-1.
Results Reference
derived
Learn more about this trial
Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
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