A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
ConditionARDS
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBonusBio Group Ltd
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients are able and agree to sign informed consent form before any study-specific procedure.
Males or females, age range 18-80.
Documented ARDS
RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
Disqualifiers
Pregnant or breast-feeding females.
History of drug abuse.
Heavy smokers (above 2 packages a day).
Subjects incapable of giving consent.
Trial design
Design model
Parallel
Treatments tested in this trial
MesenCure
Biological/VaccineEnhanced mesenchymal cell-based product
Placebo
Other interventionSaline
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: treatmentExperimental treatment 1 intervention
Group B: controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Time frame
1 month2
CRP reduction
Blood CRP is measured in mg/dL
Time frame
14 days3
Invasive ventilation
Time frame
1 monthLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: