Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT04445454

Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

Led by University of Liege · Updated on 2024-05-09

20

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

CONDITIONS

Official Title

Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 to 70 years
  • Diagnosed with COVID-19 pneumonia confirmed by microbiological or radiological tests
  • Extensive interstitial pneumonia shown on CT scan within 10 days before randomization
  • Positive COVID-19 PCR test within 14 days before inclusion or positive SARS-CoV2 PCR or serology within 14 days after inclusion
  • Require oxygen support with SpO2 ≤ 93% on room air, either in standard or intensive care unit, including mechanical ventilation for less than or equal to 7 days or 7 to 14 days with persistent high inflammation
  • Patient or legal representative provides written informed consent
Not Eligible

You will not qualify if you...

  • Current pregnancy or women of childbearing potential not using effective contraception
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • Limitations to intensity of care or life expectancy under 24 hours
  • Known allergy to investigational medicinal product components
  • Active secondary infection
  • Any malignancy (except non-melanoma skin cancer) within 2 years before inclusion
  • Pre-existing thrombo-embolic disease
  • Signs of active drug or alcohol dependence, serious illness, mental illness, or other factors interfering with study compliance
  • Serious medical conditions or abnormal lab tests judged unsafe for study participation
  • Participation in another clinical trial (compassionate use of COVID-19 drugs allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Liège

Liège, Belgium, 4000

Actively Recruiting

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Research Team

Y

Yves Beguin, MD,PhD

CONTACT

A

Audrey Janssen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection | DecenTrialz