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

Covid19 Clinical Trial

Official title:

A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716998
• Other study ID #: CP-MCS-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 14, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2021
• Source: BonusBio Group Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Health campus	Haifa
Israel	Kaplan Medical Center	Rehovot
Israel	BARUCH PADEH Medical Center, Poriya	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
BonusBio Group Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Mesencure	No treatment-related adverse reactions	30 days
Secondary	Improvement in RA-O2 saturation	Elevation to 94% and above	14 days
Secondary	Elevation of lymphocytes level	Elevation compared to day 0	14 days
Secondary	Reduction of CRP	Reduction compared to day 0	14 days
Secondary	Improvement of health questionnaire	Improvement compared to day 0	21 days
Secondary	Reduced hospitalization duration	Reduced compared to clinical site matching historical data	30 days
Secondary	improvement in pulmonary infiltrates/ pulmonary congestion	Improvement compared to day 0	30 days