Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
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|ClinicalTrials.gov Identifier: NCT04716998|
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : July 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: MesenCure||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: MesenCure treatment
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.
Three administrations of MesenCure in addition to standard care
- Safety of Mesencure [ Time Frame: 30 days ]No treatment-related adverse reactions
- Improvement in RA-O2 saturation [ Time Frame: 14 days ]Elevation to 94% and above
- Elevation of lymphocytes level [ Time Frame: 14 days ]Elevation compared to day 0
- Reduction of CRP [ Time Frame: 14 days ]Reduction compared to day 0
- Improvement of health questionnaire [ Time Frame: 21 days ]Improvement compared to day 0
- Reduced hospitalization duration [ Time Frame: 30 days ]Reduced compared to clinical site matching historical data
- improvement in pulmonary infiltrates/ pulmonary congestion [ Time Frame: 30 days ]Improvement compared to day 0
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
|Contact: Vered Kivity, PhD, MBAfirstname.lastname@example.org|
|Rambam Health campus||Recruiting|
|Haifa, Israel, 3109601|
|Contact: Shadi Hamoud, MD 972-4-7773097 email@example.com|
|Principal Investigator:||Shadi Hamoud, MD||Rambam Health Care Campus|