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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 ARDS, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Patients will receive standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

MSC - low dose (2.5x10ˆ7)

Patients will receive standard care plus cell therapy.

Group Type EXPERIMENTAL

Mesenchymal stromal cell-based therapy

Intervention Type OTHER

Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

MSC - intermediate dose (5x10ˆ7)

Patients will receive standard care plus cell therapy.

Group Type EXPERIMENTAL

Mesenchymal stromal cell-based therapy

Intervention Type OTHER

Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

MSC - high dose (10x10ˆ7)

Patients will receive standard care plus cell therapy.

Group Type EXPERIMENTAL

Mesenchymal stromal cell-based therapy

Intervention Type OTHER

Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No