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Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia (CELMA)

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ClinicalTrials.gov Identifier: NCT04429763
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Collaborators:
Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose
Hospital Infantil Universitario de San Jose
Information provided by (Responsible Party):
Trustem

Brief Summary:

The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world.

There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people.

It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Umbilical cord derived mesenchymal stem cells Biological: Placebo Phase 2

Detailed Description:

Objetive:

Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the clinical progresion and mortality of hospitalized COVID-19 patients.

Metodology:

Fase II, controled clinical trial, double blinded, compared with placebo, with paralel groups, and one to one asignation. It will be included patients between 18 and 79 years old, hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis. It will be excluded those who have indication for management in Intensive Care Unit, have any condition that seriusly affect their survival, pregnant whomen or breast feeding, those who have an advanced hearth failure, HIV infected, those who have a bacterial or fungal uncontroled infection, those who require permanent immunosupresive therapy or have had an organ trasplant, those who have no possibility to sign the informed consent format or are involved in another clinical trial with drugs or interventions.

It will vinculate 30 patients randomly assigned, by centralized electronic assignation sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human umbilical cord or to placebo group.

The primary result it will be a composed point of time to the occurrence of the clinical detriment or the death (the first that occurs) and the secondary result will be the components of each primary point, the clinical recovery, the time to the time to the discharge from the hospital, and the clinical follow-up, including respiratory function, and markers of inflammation, haematological and kidney, in addition of the safety markers.

It will be done a comparison of the incidence rates, by ratio of incidence rates and their respective confidence interval. It will be construct Kaplan-Meier curves that will compared by the statics of logaritmic rank (log-rank test).

It will be developed a multivariate analysis, with the Cox proportional risks methodology, estimating the Hazard Ratio epidemiologic.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It will be included 30 patients, randomly assigned by centralized electronic sequence of assignation, for the application of a single dosis of 1*10^6 cells/Kg or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Experimental
Usual tratment for COVID-19 plus MSC
Biological: Umbilical cord derived mesenchymal stem cells
One dosis of 1*10^6 cells/Kg

Placebo Comparator: Control
Usual treatment for COVID-19
Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Clinical deterioration or death [ Time Frame: 4 weeks ]
    Change in two or more degrees in the NEWS scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe COVID-19.
  • Infection confirmed by PCR test.
  • Hospitalized in general room (respiratory isolation area).

Exclusion Criteria:

  • Shock or multiorgan disfunction that require continous vital signs monitorization
  • Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
  • Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
  • Pregnant women or breast feeding.
  • Advanced hearth failure.
  • VIH/AIDS.
  • Bacterial or fungical uncontroled infection.
  • Permanente use of immunosupresants or have had received an organ trasnplanted in the past six months.
  • Imposibility to sign the informent consent format.
  • Patients involved in another clinical trial with drugs or interventions.

Information from the National Library of Medicine

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): NCT04429763


Contacts
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Contact: Jhon Jaime Sprockel Díaz, MD, Esp +573538000 jjsprockel@fucsalud.edu.co
Contact: Carolina Araque, MD, Esp +574377540 caroaraque@gmail.com

Sponsors and Collaborators
Trustem
Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose
Hospital Infantil Universitario de San Jose
Investigators
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Study Chair: Guillermo Sánchez-Vanegas, MD, PhD Fundación Universitaria de Ciencias de la Salud
Study Director: Carlos Escobar-Soto, MD, PhD Trustem
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Responsible Party: Trustem
ClinicalTrials.gov Identifier: NCT04429763    
Other Study ID Numbers: 202001
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Trustem:
Mesenchymal Stem Cells
Umbilical Cord