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IRCT20200426047212N2 IRCT 2021-11-11 Ahvaz University of Medical Sciences Effect of Tofacitinib in treatment of Covid-19 Efficacy of Tofacitinib/Remdesivir combination therapy compared to Remdesivir treatment on clinical status and laboratory findings of patients with severe Covid-19: A double-blind randomized clinical trial study 2021-11-06 anticipated 60 Complete https://irct.ir/trial/59636 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of samples to each of the intervention and control groups will be done by random block method and using 4 blocks. Random chains and concealment codes will be generated by www.sealedenvelope.com. To hide the random chain, the method of envelopes in opaque packages is also used, Blinding description: Participants and researchers in this study are blinded to the specialization of study groups, and an independent person from the research team, along with the Intensive Care Fellowship, prescribes the assigned codes to each patient. To ensure the similarity between the drug and the placebo, the placebo will be made by the same drug company and the study drugs will be placed in similar envelopes. 2-3 Coronavirus. Intervention 1: Intervention group: Depending on the response to treatment, group 1 will receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) in addition to the 5-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously four days later). Group 2, depending on the response to treatment, will receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) along with a 10-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously on the next nine days) . Intervention 2: Control group: Group 3, depending on the response to treatment, receives a 5-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously four days later) with placebo, which will be given twice a day for 5 days. Group 4 will also receive a 10-day Remdesivir course (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously on the next nine days) with a placebo that will be given twice daily for 5 days. 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 There is no more information
public Mehrdad Dargahi-Malamir
Razi Hospital, Felestin Ave., Ahvaz, Amanieh Ave
Ahvaz Iran (Islamic Republic of) 61965-14941 +98 61 3333 3050 Dargahi-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mandana Pouladzadeh
Razi Hospital, Felestin Ave., Ahvaz, Amanieh Ave
Ahvaz Iran (Islamic Republic of) 61965-14941 +98 61 3333 3050 mandanapouladzadeh@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) informed written desire and consent to participate in the study Age 18 years or older Hospitalization Severe disease Positive polymerase chain reaction (PCR) test Lung involvement based on CT scan 18 years no limit Both Death of the patient Physician's diagnosis of not participating in the study History of thrombosis or current thrombosis Suppression of the known immune system Pregnancy and lactation Use of angiotensin converting inhibitors Severe renal, hepatic, respiratory and cardiovascular insufficiency Consumption of cytotoxic drugs Transfer to another hospital U07. 1 COVID19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Depending on the response to treatment, group 1 will receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) in addition to the 5-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously four days later). Group 2, depending on the response to treatment, will receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) along with a 10-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously on the next nine days) . Control group: Group 3, depending on the response to treatment, receives a 5-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously four days later) with placebo, which will be given twice a day for 5 days. Group 4 will also receive a 10-day Remdesivir course (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously on the next nine days) with a placebo that will be given twice daily for 5 days. Lactate Dehydrogenase. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Blood Urea Nitrogen. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Creatinine. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Alanine Aminotransferease. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Aspartate Aminotransferase. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Alkaline Phosphatase. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. C-Reactive Protein. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. White Blood Cell. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Neutrophil. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Lymphocytus. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Red Blood Count. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Erythrocyte Sedimentation Rate. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test. Respiratory Rate. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Count the respiratory rate per minute. Percentage of oxygen saturation. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Pulse oximeter. Heart Rate. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Count the number of heart pumps per minute. Systolic blood pressure. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Calculate the pressure when the heart contracts. Body temperature. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Based on thermometer. Performance status. Timepoint: Before the intervention and one day after the intervention. Method of measurement: According to PRIEST checklist. State of consciousness. Timepoint: Before the intervention and one day after the intervention. Method of measurement: According to PRIEST checklist. Ahvaz University of Medical Sciences Approved 2021-10-09 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran Ahvaz Khouzestan Iran (Islamic Republic of)