Cell therapy in patients with COVID-19
Phase 2
Recruiting
- Conditions
- COVID-19.COVID-19U07.1
- Registration Number
- IRCT20190717044241N3
- Lead Sponsor
- Barakat Pharmaceutical Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Persistent hypoxemia despite receiving less than 93% Saturation oxygen
Respiratory failure requires a Ventilator
Chest has multilobar infiltrates
Exclusion Criteria
Patient dissatisfaction
Pregnant patient
Age under 18 years and over 65 years
Patient with known active malignancy
Shock
Organ failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response. Timepoint: 28 days-From the time of cell injection until the 28th day. Method of measurement: clinical observation by Infectious Diseases Specialist.;O2 saturation. Timepoint: Since the injection of the cell; 0,3,6 days. Method of measurement: ventilator.
- Secondary Outcome Measures
Name Time Method Inflammation cytokines. Il-6 & Il-10. Timepoint: On days 0,3,6,14 - from the time of cell injection. Method of measurement: Assay by the Elisa.;CD4 and CD8 markers. Timepoint: On days 0,3,6,14 - from the time of cell injection. Method of measurement: Flow Cytometry.;Evaluation of lung function. Timepoint: On days 0,14 - from the time of cell injection. Method of measurement: CT scan of the lungs.