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IRCT20220526054990N1 IRCT 2022-06-01 Artesh University of Medical Sciences Fluvoxamine in Long COVID Evaluation of the effect of fluvoxamine in preventing neuropsychiatric symptoms of Long COVID syndrome 2022-03-01 anticipated 96 Complete https://irct.ir/trial/63831 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done by the simple randomization method. In Excel software, a randomization table is created according to the sample size, and the letter A or B is assigned to each number from 1 to the sample size. Each letter indicates a treatment, fluvoxamine or placebo, of which the study designer and the doctor who prescribes the treatment are unaware. The drugs are placed in opaque envelopes by another person who has no other role in the analysis of the study. Patients receive one of the two diets based on the enrollment number, Blinding description: The principal investigator, analyzer, and patients are unaware of the drug given or taken. A third-person unaware of the analysis and the results prepares the placebo and the drug into identical packages. 3 Long or Post COVID syndrome. Intervention 1: Intervention group: The drug fluvoxamine maleate 50 mg fc tablet made by Jalinous Pharmaceutical Company, every 12 hours for 10 days, after 4 weeks, patients are contacted and asked about the symptoms of Long COVID based on the questionnaire. Intervention 2: Control group: placebo 1 tablet for every 12 hours for 10 days, after 4 weeks, patients are contacted and asked about the symptoms of long quiescence based on a questionnaire. Yes - There is a plan to make this available What will be shared: Part of the information about the final outcome after being unidentifiable can be shared When: Access period starts 6 months after the results are published To whom: Accessible to all academic and scientific researchers Conditions: The analysis is allowed on the delivered data Where to obtain: Ali Ajam, ali.ajam1374@gmail.com How to obtain: The request will be answered within one week after the request Comments:
public Ali Ajam
No. 46 30th Str. Asad Abadi Blvd.
Tehran Iran (Islamic Republic of) 1431946151 +98 21 8835 6498 a-ajam@alumnus.tums.ac.ir Tehran University of Medical Sciences scientific Ali Ajam
No. 46 30th Str. Asad Abadi Blvd.
Tehran Iran (Islamic Republic of) 1431946151 +98 21 8835 6498 a-ajam@alumnus.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Confirmed COVID infection by infectious disease specialist Age over 15 years 15 years no limit Both History of epilepsy History of mania History of depression Use of other antidepressants Pregnancy and lactationK Kidney dysfunction Liver dysfunction History of cardiac arrhythmia Any drug allergy to fluvoxamine, including skin allergies Severe side effects of fluvoxamine, including malignant neuroleptic syndrome Drug interactions with other drugs consumed by the patient U09.9 Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis. Treatment - Drugs Placebo Intervention group: The drug fluvoxamine maleate 50 mg fc tablet made by Jalinous Pharmaceutical Company, every 12 hours for 10 days, after 4 weeks, patients are contacted and asked about the symptoms of Long COVID based on the questionnaire. Control group: placebo 1 tablet for every 12 hours for 10 days, after 4 weeks, patients are contacted and asked about the symptoms of long quiescence based on a questionnaire. Frequency of any of the neuropsycological symptoms of Long COVID in patients. Timepoint: 4 weeks after COVID symptoms onset. Method of measurement: history taking based on a questionnaire prepared by the researcher. Artesh University of Medical Sciences Approved 2022-02-21 AJA University of Medical Sciences 13th Floor, Block A, Farahzadi Blvd, Headquarters of the Ministry of Health and Medical Education, Simaye Azadi Str., Shahrak-e Gharb Tehran Tehran Iran (Islamic Republic of)