MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

Covid19 Clinical Trial

Official title:

Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04525378
• Other study ID #: PCL02/2020
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: August 2020
• Source: D'Or Institute for Research and Education
• Contact: Bruno SF Souza, MD PHD
• Phone: +557132816455
• Email: bruno.souza[@]hsr.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of COVID-19 confirmed by RT-PCR;

• Thorax CT image suggestive of viral pneumonia;

• Respiratory failure (SaO2 <93% with O2 at 5L / min)

• Tracheal intubation (first 48 h);

Exclusion Criteria:

• Pregnancy or breastfeeding;

• Patients with a history of cancer, chemotherapy in the past 2 years;

• Life expectancy less than 6 months or in exclusive palliative care;

• Severe liver failure, with Child-Pugh score> 12;

• High probability of death in the following 48 h;

• Previous renal failure: patients who were already on dialysis or patients with RFG <30ml / min / 1.73 m2;

• Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Covid19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Mesenchymal stromal cell-based therapy
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

Locations

Country	Name	City	State
Brazil	Hospital São Rafael	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrahospital mortality		28 days
Secondary	Length of stay in the ICU and Hospital		28 days
Secondary	Days without mechanical ventilation in 28 days		28 days
Secondary	PaO2 / FiO2 ratio		Day 1, Day 2 and Day 7 after cell infusion
Secondary	Incidence of secondary infections		28 days
Secondary	Incidence of adverse events		28 days
Secondary	Quantification of inflammatory response markers	Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry	Day 1, Day 3 and Day 7 after cell infusion