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IRCT20110425006280N11 IRCT 2021-01-27 Vice President of Research Guilan university of medical sciences The effect of pentoxifylline in the treatment of Covid-19 disease Evaluation of pentoxifylline effect in treatment of patients with COVID-19, hospitalized in an intensive care unit, A randomized clinical trial 2021-01-19 anticipated 20 Complete https://irct.ir/trial/53644 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be randomly admitted to each of the two treatment groups using the randomization method with a ratio of 1:1. 20 patients with Covid-19 disease will be divided into 2 groups of 10 intervention and control. The intervention group will be named A and the control group will be named B. Random blocking will be such that the patients will be assigned numbers 1 to 20, respectively. Then a table will be considered with 6 rows called blocks and each block with 4 parts and each part will be named A and B. In the next step, the numbers will be placed in each cell in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the intervention medicine and the people who had the number in house B will be considered as the control group. The website https://www.sealedenvelope.com will be used for randomization, Blinding description: Each patient's group therapy will be determined only after randomization. Participants and health care providers responsible for patients' health will not go blind and will be informed about group therapy. Radiologists, research evaluators, and statisticians will be blind to patients' group therapy. The Sequentially numbered opaque, sealed envelopes: Envelopes method is used to hide random allocation. 2 The effect of pentoxifylline in the treatment of covid-19 disease. Intervention 1: Intervention group: This study is performed in critically ill patients with COVID-19 admitted to Razi Hospital after obtaining informed consent from the patient or their companions.The 10 eligible patients randomly selected will receive the national standard COVID-19 treatment regimen with pentoxifylline. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.The dose of pentoxifylline is 400 milligrams, which is determined based on creatinine clearance of the patient as follows: Creatinine clearance above 50 milliliters per minute: three times a day, creatinine clearance 10 to 50 milliliters per minute: twice a day, Creatinine clearance less than 10 milliliters per minute: once daily. The treatment period for patients is 14 days. For 14 days, they will be monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups will be compared in terms of treatment effectiveness and possible side effects of treatment. Intervention 2: Control group: 10 patients receive the standard COVID-19 treatment regimen based on national protocol. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.For 14 days, patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups are compared in terms of treatment effectiveness and possible side effects of treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Mohammad Haghighi
Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 4193713194 +98 13 1322 3970 manesthesist@gmail.com Guilan University of Medical Sciences scientific Mohammad Haghighi
Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 4193713194 +98 13 1322 3970 manesthesist@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Patients with a clinical diagnosis of respiratory distress and dyspnea with SPAO2 less than 93% or positive PCR and radiographic test on CT SCANNING or Chest X-Ray admitted to the intensive care unit 18 years 75 years Both pregnant patients patients who get under therapy for less than 3 days U07.1 COVID-19, virus identified Treatment - Drugs Other Intervention group: This study is performed in critically ill patients with COVID-19 admitted to Razi Hospital after obtaining informed consent from the patient or their companions.The 10 eligible patients randomly selected will receive the national standard COVID-19 treatment regimen with pentoxifylline. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.The dose of pentoxifylline is 400 milligrams, which is determined based on creatinine clearance of the patient as follows: Creatinine clearance above 50 milliliters per minute: three times a day, creatinine clearance 10 to 50 milliliters per minute: twice a day, Creatinine clearance less than 10 milliliters per minute: once daily. The treatment period for patients is 14 days. For 14 days, they will be monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups will be compared in terms of treatment effectiveness and possible side effects of treatment. Control group: 10 patients receive the standard COVID-19 treatment regimen based on national protocol. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.For 14 days, patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups are compared in terms of treatment effectiveness and possible side effects of treatment. Clinical signs of COVID-19 disease. Timepoint: Daily in the morning visit for 14 days. Method of measurement: Observe, measure and record fever, cough, shortness of breath, olfactory and taste disorders, headache, gastrointestinal symptoms, chills and . Percentage of oxygen saturation. Timepoint: Daily in the morning visit for 14 days. Method of measurement: Based on measurements with pulse oximetery. Patient`s recovery. Timepoint: Daily in the morning visit for 14 days. Method of measurement: No need for supplemental oxygen or mechanical ventilation and ICU discharge. Vice President of Research Guilan university of medical sciences Approved 2021-01-06 Ethical Comeetee of Guilan University of Medical Sciences Namjoo Avenue, Deputy department OF Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)