Covid19
Conditions
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.
Interventions
BIOLOGICALMesenCure
Three administrations of MesenCure in addition to standard care
Sponsors
BonusBio Group Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The treatment group consisted of 50 patients, treated with MesenCure in addition to the standard of care (SoC). A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SoC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Mesencure | 30 days | No treatment-related adverse reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in RA-O2 saturation | 14 days | Elevation to 94% and above |
| Elevation of lymphocytes level | 14 days | Elevation compared to day 0 |
| Reduction of CRP | 14 days | Reduction compared to day 0 |
| Reduced hospitalization duration | 30 days | Reduced compared to clinical site matching historical data |
| improvement in pulmonary infiltrates/ pulmonary congestion | 30 days | Improvement compared to day 0 |
| Improvement of health questionnaire | 21 days | Improvement compared to day 0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality rate | 30 days | The morality rate (%) was monitored in the treatment group and compared with the the mortality rate of retrospective control group |
| Progressing to invasive ventilation | The latest of: four (4) weeks or until patient release from hospital. | The proportion of the patients progressing to invasive ventilation was measured in the treatment group and compared to the proportion of retrospective control group patient progressing to invasive ventilation |
Countries
Israel
Outcome results
None listed