severe covid-19 patients. COVID-19, virus identified
Conditions
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Aged 40-65 years Voluntarily participate in this clinical trial and sign off "informed consent form" Chest imaging confirm COVID-19 featured lesions in the lung The SARS-CoV-2 nucleic acid test was positive Diagnosed with severe pneumonia of COVID-19: respiratory distress, Respiratory rate (RR) = 30 times/min; resting oxygen saturation of 90% or less; arterial pressure of oxygen/the fraction of inspired oxygen= 300 mmHg; pulmonary imaging of focus within 24-48 hours > 50% progression
Exclusion criteria
Exclusion criteria: History of drug reactions or allergies Pneumonia caused by bacteria, Mycoplasma, Chlamydia, Legionella, fungi, or other viruses Airway obstruction due to lung cancer or unknown factors Carcinoid syndrome History of epilepsy and long-term use of anticonvulsant drugs during the last 3 years History of long-term use of immunosuppressive drugs History of chronic respiratory illness that requires long-term oxygen therapy The patient is on blood or peritoneal dialysis Creatinine clearance 12) History of deep vein thrombosis (DVT) or pulmonary embolism over the past 3 years Being under ECMO or high-frequency oscillatory ventilation support Diagnostic of HIV, hepatitis B, and syphilis Pregnant or lactating women Lack of consciousness and inability to provide informed consent by the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the number of CD4 + and CD8 + T cells. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Evaluation of allergic reaction to infusion of secretome derived from menstrual blood-derived allogeneic stem cells in patients with severe pneumonia caused by Covid-19. Timepoint: Simultaneously with each intervention, 24 hours after each intervention, Day 7 after the first intervention. Method of measurement: Clinical evaluation of this adverse effect according to CTCAE Version4 form.;Decrease in serum CRP levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in serum levels of lactate dehydrogenase. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in serum Ferritin levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in serum D-Dimer levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Increase in interleukin-10 levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Decrease in interleukin-10 levels. Timepoint: On days 0, 3, 5, 7, 10, 14, 21, 28 after the first intervention. Method of measurement: Laboratory evaluation.;Reduce the size of the lesion on CT scan of the lungs. Timepoint: On days 0, 5, 10, 28 after the first intervention. Method of measurement: CT Scan.;Evaluation of injection site reaction of secretome derived from menstrual blood-derived allogeneic stem cells in patients with severe pneumonia caused by Covid-19. Timepoint: Simultaneously with each intervention, 24 hours after each intervention, Day 7 after the first intervention. Method of measurement: Number of participants with t | — |
Secondary
| Measure | Time frame |
|---|---|
| Improving respiratory efficiency. Timepoint: Before the intervention until the one month after the first intervention on a daily basis. Method of measurement: Measuring PaO2 / FiO2 ratio or percentage of blood oxygenation.;Increasing the number of patients weaning from mechanical ventilation. Timepoint: Daily for one month after the first injection. Method of measurement: Observation.;Reduce the number of days hospitalized in the ICU. Timepoint: Daily for one month after the first injection. Method of measurement: Observation.;Reducing the incidence of failure of various organs. Timepoint: Daily for one month after the first injection. Method of measurement: Observation.;Reduce mortality rate. Timepoint: Daily for one month after the first injection. Method of measurement: Counting people. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Dehghan Manshadi
Tehran University of Medical Sciences
Outcome results
None listed