MedPath

Cell therapy in patients with COVID-19

Phase 2
Recruiting
Conditions
COVID-19.
COVID-19
U07.1
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
NameTimeMethod
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
NameTimeMethod
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.
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