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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: MesenCure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MesenCure treatment<br>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<br>* Three administrations of MesenCure in addition to standard care<br>|

What is the study measuring?
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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 |