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IRCT20131115015405N4 IRCT 2020-10-03 Shahid Beheshti University of Medical Sciences Effect of fluvoxamine on cytokine in COVID-19 patients Effect of fluvoxamine medicine on cytokine level of COVID-19 patients, hospitalized in ICU ward 2020-07-22 anticipated 40 Complete https://irct.ir/trial/50977 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization method is applied, which the written names of the participants are placed in a container, separately. Then one of the members of research team choose 20 of them randomly, as the intervention group, without the possibility of seeing the names. The rest of 20 names are allocated to control group. 2-3 COVID-19. Intervention 1: Intervention group: This group will be treated by Fluvoxamine drug. The drug dosage will be increased up to 300 mg daily depending on the patients tolerance to the drug. At first, 50 mg will be prescribed per night. after 2 days, 100 mg will be prescribed per night. After 4 days, 100 mg will be prescribed per afternoon and 100 mg will be prescribed per night. After 4 days, 100 mg will be prescribed per morning, 100 mg will be prescribed per afternoon and 100 mg will be prescribed per night. Pharmaceutical companies including Abidi and Sobhan produce Fluvoxamine drug in Iran. Thus, the Fluvoxamine produced by each of the mentioned pharmaceutical companies will be used in the current project. Intervention 2: Control group: This group will not receive Fluvoxamine drug. But all of the members undergo COVID-19 treatment in Intensive Care Unit under the supervision of the specialist physician, like the intervention group. Yes - There is a plan to make this available What will be shared: All participants data will be presented as article, when finalizing the work, because their data does not contain identification information. When: Accessing to data would be possible after publication of the article. To whom: All academic researchers can access to data. Conditions: When the article is published, all academic researchers can send a request for accessing the data, then the results will be announced after some considerations. Where to obtain: The corresponding author and his/her email address will be determined in published article, which every one who needs the data can use it. How to obtain: When the applicant send a request through email address, the results will be announced in a week. Comments:
public Mitra Safa
Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2607 mitra.safa@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mitra Safa
Massih Daneshvari hospital, Daar-Abad, Niavaran, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2607 mitra.safa@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Informed consent Being conscious Definite diagnosis of COVID-19 in medical records of the patient Age over 18 years old Normal serum level of Creatinine, Blood Ureh Nitrogen, White Blood Cell, Potassium, Sodium and Fasting Blood Sugar 18 years no limit Both Being pregnant. Existence of ASA, Warfarin, MAOI, Lithium, Clomipramine, NSAIDs, Methadone, Capropril, Diltiazem and Zolpidem drugs in medical files of the patient. Simultaneous consumption of any kind of alcohol or substance. U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: This group will be treated by Fluvoxamine drug. The drug dosage will be increased up to 300 mg daily depending on the patients tolerance to the drug. At first, 50 mg will be prescribed per night. after 2 days, 100 mg will be prescribed per night. After 4 days, 100 mg will be prescribed per afternoon and 100 mg will be prescribed per night. After 4 days, 100 mg will be prescribed per morning, 100 mg will be prescribed per afternoon and 100 mg will be prescribed per night. Pharmaceutical companies including Abidi and Sobhan produce Fluvoxamine drug in Iran. Thus, the Fluvoxamine produced by each of the mentioned pharmaceutical companies will be used in the current project. Control group: This group will not receive Fluvoxamine drug. But all of the members undergo COVID-19 treatment in Intensive Care Unit under the supervision of the specialist physician, like the intervention group. Interlukine - 6 (IL-6) level will be measured in COVID-19 patients. Timepoint: The Interlukine - 6 level will be measured both before the consumption of Fluvoxamine drug and when discharging from the ICU ward. Method of measurement: Measuring kit of Interlukine - 6 by blood test. Erythrocyte Sedimentation Rate (ESR) level will be measured in COVID-19 patients. Timepoint: The Erythrocyte Sedimentation Rate (ESR) level will be measured both before the consumption of Fluvoxamine drug and when discharging from the ICU ward. Method of measurement: Measuring kit of Erythrocyte Sedimentation Rate (ESR) by blood test. C-Reactive Protein (CRP) level will be measured in COVID-19 patients. Timepoint: The C-Reactive Protein (CRP) level will be measured both before the consumption of Fluvoxamine drug and when discharging from the ICU ward. Method of measurement: Measuring kit of C-Reactive Protein (CRP) by blood test. Shahid Beheshti University of Medical Sciences Approved 2020-09-16 National Research Institute of Tuberculosis and Lung Diseases Massih Daneshvari Hospital, Daar-Abad, Niavaran, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)