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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Biological: MesenCure

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Vered Kivity, PhD, MBA; Phone Number: 972-73-2067154; Email: veredki@bonus-bio.com

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Campus
  • Rehovot, Israel, 7661041
    • Kaplan Medical Center
  • Tiberias, Israel, 15208
    • Baruch Padeh Medical center, Poriya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Mesencure	No treatment-related adverse reactions	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in RA-O2 saturation	Elevation to 94% and above	14 days
Elevation of lymphocytes level	Elevation compared to day 0	14 days
Reduction of CRP	Reduction compared to day 0	14 days
Improvement of health questionnaire	Improvement compared to day 0	21 days
Reduced hospitalization duration	Reduced compared to clinical site matching historical data	30 days
improvement in pulmonary infiltrates/ pulmonary congestion	Improvement compared to day 0	30 days

Collaborators and Investigators

• Sponsor: BonusBio Group Ltd
• Investigators: Principal Investigator: Shadi Hamoud, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CP-MCS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No