Clinical trial NCT04716998: Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
Official title: A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: BonusBio Group Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of Mesencure
timeFrame: 30 days
Secondary outcomes:
measure: Improvement in RA-O2 saturation
timeFrame: 14 days
measure: Elevation of lymphocytes level
timeFrame: 14 days
measure: Reduction of CRP
timeFrame: 14 days
measure: Improvement of health questionnaire
timeFrame: 21 days
measure: Reduced hospitalization duration
timeFrame: 30 days
measure: improvement in pulmonary infiltrates/ pulmonary congestion
timeFrame: 30 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health campus
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tiberias
country: Israel
facility: BARUCH PADEH Medical Center, Poriya
Study officials:
affiliation: Rambam Health Care Campus
name: Shadi Hamoud, MD
role: PRINCIPAL_INVESTIGATOR
References: