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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429763
Recruitment Status : Unknown
Verified June 2020 by Trustem.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE June 10, 2020
First Posted Date  ICMJE June 12, 2020
Last Update Posted Date June 12, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
Clinical deterioration or death [ Time Frame: 4 weeks ]
Change in two or more degrees in the NEWS scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia
Official Title  ICMJE Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Umbilical cord derived mesenchymal stem cells
    One dosis of 1*10^6 cells/Kg
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Experimental
    Usual tratment for COVID-19 plus MSC
    Intervention: Biological: Umbilical cord derived mesenchymal stem cells
  • Placebo Comparator: Control
    Usual treatment for COVID-19
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04429763
Other Study ID Numbers  ICMJE 202001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Trustem
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Trustem
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Fundación Universitaria de Ciencias de la Salud
  • Hospital de San Jose
  • Hospital Infantil Universitario de San Jose
Investigators  ICMJE
Study Chair: Guillermo Sánchez-Vanegas, MD, PhD Fundación Universitaria de Ciencias de la Salud
Study Director: Carlos Escobar-Soto, MD, PhD Trustem
PRS Account Trustem
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP