ARDS, COVID-19
Conditions
Brief summary
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Interventions
BIOLOGICALMSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COVID-19-positive subject * Horowitz index ≤ 200 * Bilateral opacities on frontal chest radiograph, and * requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation * no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg. * Subject's Age ≥ 18 years
Exclusion criteria
* COVID-19-negative subject * Subject's Age \< 18 years * More than 7 days since initiation of mechanical ventilation * Patient, surrogate or physician not committed to full intensive care support. * Positive Pregnancy test at the time of screening. * Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lung injury score | day 10 | improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| phenotype | day 0, 1, 2, 3, 10 and 15 | distribution of phenotypes of immune cells |
| pro-resolving lipid mediators | day 0, 1, 2, 3, 10 and 15 | Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage |
| cytokines | day 0, 1, 2, 3, 10 and 15 | Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions |
| chemokines | day 0, 1, 2, 3, 10 and 15 | Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions |
| D-dimers | day 0, 1, 2, 3, 10 and 15 | D-dimers blood levels |
| extubation | day 28 | Time to removal of endotracheal tube |
| lymphocyte subpopulations | day 0, 3, 5 and 10 | lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10) |
| SARS-CoV-2-specific antibody titers | day 0, 5 and 10 | evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion. |
| complement molecules (C5-C9) | day 0, 5 and 10 | evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion |
| Survival | day 10 and 28 | Survival at 10 days and 28 days |
Countries
Germany
Contacts
Primary ContactPeter Rosenberger, Prof.
Outcome results
None listed