Clinical trial of administration of MSC to patients with respiratory distress type COVID-19

Phase 1

• Conditions: Respiratory distress secondary to SARS-Cov-2 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001266-11-ES
• Lead Sponsor: Fundación Instituto de Investigación Sanitaria Fundación Jiménez Diaz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-16
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Patients of both sexes.
-Over 18 years.
-Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
-Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
-Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg.
-Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
-Written or verbal informed consent from the patient or the legal representative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
-RT-PCR of SARS-Cov-2 negative.
Mult Multi-organ failure (more than three organs)
-Severe respiratory failure requiring extracorporeal support (ECMO)
-Moderate- severe COPD requiring chronic home oxygen therapy.
-Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
-Active tumor disease.
-Previous immunosuppressive treatment.
-Allergy or hypersensitivity to the administered products.
-History of deep vein thrombosis or pulmonary embolism in the last 3 years.
-Participation in other clinical trials during the 3 months prior to the initial visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified