ARDS
Conditions
Brief summary
The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients
Interventions
BIOLOGICALMesenCure
Enhanced mesenchymal cell-based product
OTHERPlacebo
Saline
Sponsors
BonusBio Group Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are able and agree to sign informed consent form before any study-specific procedure. 2. Males or females, age range 18-80. 3. Documented ARDS 4. RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography 5. Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)
Exclusion criteria
General: 1. Pregnant or breast-feeding females. 2. History of drug abuse. 3. Heavy smokers (above 2 packages a day). 4. Subjects incapable of giving consent. Background medical conditions: 1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation. 2. History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C). 3. Known autoimmune diseases. 4. Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 month | — |
| CRP reduction | 14 days | Blood CRP is measured in mg/dL |
| Invasive ventilation | 1 month | — |
Outcome results
None listed