NCT05497401Not yet recruitingPhase 3
A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- BonusBio Group Ltd
- Enrollment
- 300
- Primary Endpoint
- CRP reduction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients are able and agree to sign informed consent form before any study-specific procedure.
- •Males or females, age range 18-
- •Documented ARDS
- •RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
- •Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
Exclusion Criteria
- •Pregnant or breast-feeding females.
- •History of drug abuse.
- •Heavy smokers (above 2 packages a day).
- •Subjects incapable of giving consent.
- •Background medical conditions:
- •Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
- •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).
- •Known autoimmune diseases.
- •Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
- •Immunocompromised condition from any reason, at screening.
- •Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
- •Poorly controlled diabetic subjects (HbA1c > 9%).
- •Known active lung malignancy.
- •Concomitant treatment:
- •Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID
- •Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.
- •Hypersensitivity:
- •Known history of hypersensitivity to Dextran-
- •Known history of hypersensitivity to Human Serum Albumin.
Arms & Interventions
treatment
Experimental
Intervention: MesenCure (Biological)
control
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
CRP reduction
Time Frame: 14 days
Blood CRP is measured in mg/dL
Mortality
Time Frame: 1 month
Invasive ventilation
Time Frame: 1 month
Secondary Outcomes
No secondary outcomes reported
Investigators
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