hCT-MSCs for COVID19 ARDS
COVID, Corona Virus Infection, COVID19
About this trial
This is an interventional treatment trial for COVID focused on measuring COVID, Coronavirus infection, COVID19, Covid ARDS, Acute Respiratory Distress Syndrome, ARDS
Eligibility Criteria
Inclusion Criteria:
- The patient or legally authorized representative (LAR) must have the ability to understand and the willingness to provide a signed and dated informed consent form.
- Age 18 years and over
- The patient agrees to use adequate contraception for the duration of the treatment protocol and for 6 months post treatment.
- Positive RT- PCR testing for COVID-19 nucleic acid using nasopharyngeal swabbing or any other site
Patient meets ARDS criteria and is on non-invasive or mechanical ventilation or high flow nasal cannula
- bilateral opacities on chest imaging consistent with pulmonary edema
- A need for positive pressure ventilation or high flow nasal cannula
- PaO2/FiO2 ratio ≤ 300 mmHg by arterial blood gas or SpO2/FiO2 imputation.
- Infiltrates not fully explained by cardiac failure or fluid overload in the physician's best clinical judgement
- Subjects requiring dialysis as a result of a COVID-19 infection will not be excluded.
Exclusion Criteria:
Evidence of multiorgan failure involving one or more organs, excluding the lungs as defined below:
- Presence of shock, defined as MAP < 65 mmHg with signs of peripheral hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents to maintain MAP ≥ 65 mmHg.
- Serum bilirubin > 10 mg/dl
- Platelet count < 50,000/ml
- Subjects requiring dialysis as a result of anything other than a COVID-19 infection will be excluded
- Evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy excluding steroid use for treatment of COVID-19 acute respiratory failure, HIV, previous treatment for cancer, etc.)
- History of metastatic cancer diagnosis or treatment in the past 1 year
- History of previous treatments with MSCs or other cell therapies
- Patient is co-enrolled in any other IND-sponsored clinical trials for COVID-19 or ARDs. Drugs that are administered under emergency use authorizations (EUA) by the FDA are permitted.
- Evidence of pregnancy or lactation
- Moribund patient not expected to survive >24 hours
- Unable/unwilling to deliver lung protective ventilation
- Patient is receiving Extracorporeal Membrane Oxygenation (ECMO)
Sites / Locations
- Boca Raton Regional Hospital
- Jackson Memorial Hospital
- University of Miami Hospital
- New York Medical College
- Duke Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Open Label infusion of hCT-MSC
Randomized infusion of hCT-MSC
Randomized infusion of Placebo
The first 10 consecutive patients will all receive investigational product.
An interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo. The investigational product will be further randomized to the MSCs manufactured by Duke or University of Miami. These products are considered to be comparable.
An interim analysis, for safety will be conducted and reviewed by the Data Safety and Monitoring Board (DSMB) after the first 10 patients have completed treatment and reached the 28 day endpoint. If there are no safety concerns, the trial will proceed with enrollment on the phase 2 portion of the study where the subsequent 40 patients will be randomized in a 1:1 fashion between treatment with MSCs and placebo