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

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.

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.