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Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716998
Recruitment Status : Unknown
Verified January 2021 by BonusBio Group Ltd.
Recruitment status was:  Recruiting
First Posted : January 20, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
BonusBio Group Ltd

Study Description
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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

Condition or disease Intervention/treatment Phase
Covid19 Biological: MesenCure Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19
Actual Study Start Date : January 14, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MesenCure treatment

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.

 Biological: MesenCure
Three administrations of MesenCure in addition to standard care


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Mesencure [ Time Frame: 30 days ]
    No treatment-related adverse reactions


Secondary Outcome Measures :
  1. Improvement in RA-O2 saturation [ Time Frame: 14 days ]
    Elevation to 94% and above

  2. Elevation of lymphocytes level [ Time Frame: 14 days ]
    Elevation compared to day 0

  3. Reduction of CRP [ Time Frame: 14 days ]
    Reduction compared to day 0

  4. Improvement of health questionnaire [ Time Frame: 21 days ]
    Improvement compared to day 0

  5. Reduced hospitalization duration [ Time Frame: 30 days ]
    Reduced compared to clinical site matching historical data

  6. improvement in pulmonary infiltrates/ pulmonary congestion [ Time Frame: 30 days ]
    Improvement compared to day 0


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Female subjects are eligible only if of non-child bearing potential.
  4. Documented COVID19
  5. O2 Saturation of ≤93%
  6. Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
  7. Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.

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 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).
  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 exclusion criteria).
  5. Immunocompromised condition from any reason, at screening.
  6. Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
  7. Poorly controlled diabetic subjects (HbA1c > 9%).
  8. Known active lung malignancy.

Concomitant treatment:

  1. Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
  2. Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.

Hypersensitivity:

  1. Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
  2. Known history of hypersensitivity to Human Serum Albumin.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716998


Contacts
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Contact: Vered Kivity, PhD, MBA 972-73-2067154 veredki@bonus-bio.com

Locations
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Israel
Rambam Health campus Recruiting
Haifa, Israel, 3109601
Contact: Shadi Hamoud, MD    972-4-7773097    s_hamoud@rmc.gov.il   
Sponsors and Collaborators
BonusBio Group Ltd
Investigators
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Principal Investigator: Shadi Hamoud, MD Rambam Health Care Campus
More Information
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Responsible Party: BonusBio Group Ltd
ClinicalTrials.gov Identifier: NCT04716998    
Other Study ID Numbers: CP-MCS-01
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases