COVID-19 trials registries data warehouse

http://en.irct.ir/trial/54971

Mohammad-Reza Sadeghi

sadeghi@ari.ir

2021-04-01

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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 <15 ml / min Moderate to severe liver disease (Child-Pugh score> 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

2

Iranian academic center for education culture and research

40

65

Iran

Severe disease at enrollment

6: Severe disease at enrollment

30

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 Increase in the number of CD4 + and CD8 + T cells Decrease in serum CRP levels Decrease in serum levels of lactate dehydrogenase Decrease in serum Ferritin levels Decrease in serum D-Dimer levels Increase in interleukin-10 levels Decrease in interleukin-10 levels Reduce the size of the lesion on CT scan of the lungs Evaluation of injection site reaction of secretome derived from menstrual blood-derived allogeneic stem cells in patients with severe pneumonia caused by Covid-19

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 598, "treatment_name": "Human menstrual blood-derived stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]