Back to resultsSafety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
MesenCure
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Patients are able and agree to sign informed consent form before any study-specific procedure.
- Males or females, age range 18-80.
- Female subjects are eligible only if of non-child bearing potential.
- Documented COVID19
- O2 Saturation of ≤93%
- Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
- Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.
Exclusion Criteria:
General:
- 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 significant heart diseases, 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 COVID19.
- Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.
Hypersensitivity:
- Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
- Known history of hypersensitivity to Human Serum Albumin.
Sites / Locations
- Rambam Health campus
- Kaplan Medical Center
- BARUCH PADEH Medical Center, Poriya
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MesenCure treatment
Arm Description
Clinical interventions: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, x-ray. Blood tests: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
Outcomes
Primary Outcome Measures
Safety of Mesencure
No treatment-related adverse reactions
Secondary Outcome Measures
Improvement in RA-O2 saturation
Elevation to 94% and above
Elevation of lymphocytes level
Elevation compared to day 0
Reduction of CRP
Reduction compared to day 0
Improvement of health questionnaire
Improvement compared to day 0
Reduced hospitalization duration
Reduced compared to clinical site matching historical data
improvement in pulmonary infiltrates/ pulmonary congestion
Improvement compared to day 0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04716998
Brief Title
Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
Official Title
A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BonusBio Group Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients
Detailed Description
Primary endpoint: The IV administration of MesenCure is safe under the following conditions: in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical situation and radiologic findings.
Secondary endpoint: The IV administration of MesenCure is efficacious under the following conditions:
Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, hospitalization duration.
______________________________________________________ Laboratory findings: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
______________________________________________________ Radiologic findings: pulmonary infiltrates, pleural effusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MesenCure treatment
Arm Type
Experimental
Arm Description
Clinical interventions:
Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, x-ray.
Blood tests: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.
Intervention Type
Biological
Intervention Name(s)
MesenCure
Intervention Description
Three administrations of MesenCure in addition to standard care
Primary Outcome Measure Information:
Title
Safety of Mesencure
Description
No treatment-related adverse reactions
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Improvement in RA-O2 saturation
Description
Elevation to 94% and above
Time Frame
14 days
Title
Elevation of lymphocytes level
Description
Elevation compared to day 0
Time Frame
14 days
Title
Reduction of CRP
Description
Reduction compared to day 0
Time Frame
14 days
Title
Improvement of health questionnaire
Description
Improvement compared to day 0
Time Frame
21 days
Title
Reduced hospitalization duration
Description
Reduced compared to clinical site matching historical data
Time Frame
30 days
Title
improvement in pulmonary infiltrates/ pulmonary congestion
Description
Improvement compared to day 0
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are able and agree to sign informed consent form before any study-specific procedure.
Males or females, age range 18-80.
Female subjects are eligible only if of non-child bearing potential.
Documented COVID19
O2 Saturation of ≤93%
Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.
Exclusion Criteria:
General:
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 significant heart diseases, 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 COVID19.
Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.
Hypersensitivity:
Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
Known history of hypersensitivity to Human Serum Albumin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadi Hamoud, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
BARUCH PADEH Medical Center, Poriya
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
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