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IRCT20170609034406N8 IRCT 2021-08-26 Tabriz University of Medical Sciences Investigation of the effect of pentoxifylline on Covid-19 Evaluation of the effect of pentoxifylline in reducing the complications of Covid _19 2021-09-23 anticipated 100 Complete https://irct.ir/trial/53999 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Permuted Block Randomization method will be used for entering patients into control and treatment groups. There will exist 25 blocks with equal number of patients from each group in this study. Random numbers will be generated by using the Microsoft Excel Spreadsheet Software to randomize blocks and patients allocation. 3 COVID _19. Intervention 1: Intervention group (Pentoxifylline recipient + standard care): 100 patients with COVID-19 diagnosis will be included in the study according to the inclusion and exclusion criteria and will receive 400mg pentoxifylline tablet (produced by Amin pharmaceutical company in Iran) three times daily for 1 month along with the standard care of the Ministry of Health protocol. Intervention 2: Control group: In this clinical study, the control group will receive only the standard care of the Ministry of Health protocol for COVID-19 patients for 1 month. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Dr Afshin Gharekani
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3337 2250 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr Afshin Gharekani
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5766414766 +98 41 3337 2250 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Positive PCR test for nasopharyngeal sample or certain evidence indicating Covid-19 disease Moderate to mild symptoms onset of symptoms within 7 days Ability to swallow Age between 18 and 75 18 years 75 years Both Shock state or multi-organ failure Chronic liver disease Chronic kidney disease Pregnancy and lactation Participation in other clinical studies Receiving drugs with severe interaction with pentoxifylline U10.9 Multisystem inflammatory syndrome associated with COVID_19 Treatment - Drugs Treatment - Drugs Intervention group (Pentoxifylline recipient + standard care): 100 patients with COVID-19 diagnosis will be included in the study according to the inclusion and exclusion criteria and will receive 400mg pentoxifylline tablet (produced by Amin pharmaceutical company in Iran) three times daily for 1 month along with the standard care of the Ministry of Health protocol. Control group: In this clinical study, the control group will receive only the standard care of the Ministry of Health protocol for COVID-19 patients for 1 month. Serum Procalcitonin level. Timepoint: At the beginning and end of the study. Method of measurement: Procalcitonin kit. Serum Ferritin level. Timepoint: At the beginning and end of the study. Method of measurement: Ferritin kit. Serum NT_ProBNP level ( Brain natriuretic peptide ). Timepoint: At the beginning and end of the study. Method of measurement: Nt_ProBNP ELISA Kit. Serum D_dimer level. Timepoint: At the beginning and end of the study. Method of measurement: D_dimer ELISA kit. ُُSerum LDH (Lactate Dehydrogenase) level. Timepoint: At the beginning and end of the study. Method of measurement: DGKC Kit. Partial Thromboplastin Time ( PTT) and prothrombin Time (PT). Timepoint: At the beginning and end of the study. Method of measurement: PTT and PT Kit. Saturation of Peripheral Oxygen in arterial blood ( SPO2 ). Timepoint: At the beginning and end of the study. Method of measurement: Arterial Blood Gas (ABG Test). Serum C_ reactive protein (CRP) level. Timepoint: At the beginning and end of the study. Method of measurement: CRP ELISA Kit. Reducing the length of hospital stay of patients. Timepoint: At the end of study. Method of measurement: Comparing the number of hospitalization days between the intervention group and control group. Improving the quality of lung lesions. Timepoint: At the beginning and end of the study. Method of measurement: CT_Scan of lungs. Change in the sense of smell. Timepoint: At the beginning and end of the study. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2021-02-14 Ethics committee of Tabriz University of Medical Sciences Research Vice-Chancellor, Third floor, No 2 central building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)