COVID-19 trials registries data warehouse

http://en.irct.ir/trial/57961

Mohammad-Reza Sadeghi

sadeghi@ari.ir

2021-08-12

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 Patients with a diagnosis of moderate pneumonia caused by Covid-19: 1- Presence of respiratory symptoms (including shortness of breath, feeling of pain and pressure in the chest, ...) with or without fever equal to / greater than 38 ° C 2- Percentage of blood oxygen saturation in Room air at rest between 90 to 93% 3-Pulmonary infiltration less than 50%

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

20

75

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

90

Decrease in serum CRP levels Decrease in serum levels of lactate dehydrogenase Decrease in serum D-Dimer levels Decrease in lymphopenia percentage Reduce the size of the lesion on CT scan of the lungs

Phase 3

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