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IRCT20220827055798N1 IRCT 2022-10-07 Fasa University of Medical Sciences The effect of ivermectin and fluoxetine on the amelioration of mild covid-19 patients The effect of combined regimen of ivermectin and fluoxetine on the prevention of hospitalization and amelioration of symptoms in mild covid-19 patients 2022-09-23 anticipated 144 Complete https://irct.ir/trial/65778 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are assigned to four treatment groups A, B, C, and D using Balance block randomization in an online source, https://www.randomizer.org/. the size of each block is 9 and the total number of blocks is 16. The balanced randomization allocation method will be used for the participants in the randomized controlled clinical trial study to investigate the effect of ivermectin (group A), fluvoxamine (group B), the combination of ivermectin and fluvoxamine (group C), and placebo (group D), Blinding description: Capsules containing the original drug and placebo (similar in appearance, smell, and taste to the original drug) are blinded only with completely random coding that only the person responsible for data protection and grouping is aware of. In this way, none of the people who participate in the study, the project researchers, and those who are communicating and evaluating the patients will know how to allocate groups and drugs. Finally, for analysis, the groups are only numbered based on numbers, which are only available to the data protection officer. The analyst does not know which of the studied groups will be the intervention and which will be the witnesses. 3 Covid-19. Intervention 1: Ivermectin group: in this group, in addition to the standard treatment, participants in this group will receive daily doses of ivermectin according to their weight range (48 to 50 kg, 9 mg; 51 to 80 kg, 12 mg; and >80 kg, 0.2 mg/kg). Intervention 2: Fluoxetine intervention group: in this group, in addition to the standard treatment, the participants in this group will receive 20mg capsules daily. Intervention 3: ivermectin + fluoxetine intervention group: in this group, in addition to the standard treatment, the participants in this group will receive 20 mg of fluoxetine capsules daily and ivermectin (48 to 50 kg, 9 mg; 51 to 80 kg, 12 mg; and >80 kg, 0.2 mg/kg) daily. Intervention 4: Control group: Participants in this group will receive only standard treatment according to the guidelines of the Ministry of Health. Yes - There is a plan to make this available What will be shared: The study will be uploaded as a protocol and preprint When: at the end of the statistical analysis To whom: Judicial officers and licensed researchers Conditions: People who intend to conduct research in an official voice and according to international conventions have received an official letter of cooperation from the ethics committee center. Where to obtain: academic email How to obtain: Refer to the ethics committee and obtain the necessary permission to provide data Comments:
public Majid Damiri
Ebn Sina square
Fasa Iran (Islamic Republic of) 7157847513 +98 71 5335 0994 fahimeaasadi@gmail.com Fasa University of Medical Sciences scientific Majid Damiri
Ebn Sina square
Fasa Iran (Islamic Republic of) 7157847513 +98 71 5335 0994 fahimeaasadi@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) positive covid-19 PCR Completion of the informed consent questionnaire 18 years 65 years Both Taking any SSRI for 10 days before the onset of clinical symptoms and going to the clinic History of mental illnesses Inability or unwillingness to continue studying The need for oxygen therapy or a history of home oxygen therapy History of chronic kidney and liver diseases Use of warfarin, ACE inhibitor, angiotensin II receptor antagonists Acquired immune system deficiency diseases Pregnancy or breastfeeding9- Malnutrition diseases Use of macrocyclic lactone drug family Use of ivermectin for 7 days before the symptoms of covid-19 Dialysis Participants who have participated in another trial study in the last six months. J06 Acute upper respiratory infections of multiple and unspecified sites Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Ivermectin group: in this group, in addition to the standard treatment, participants in this group will receive daily doses of ivermectin according to their weight range (48 to 50 kg, 9 mg; 51 to 80 kg, 12 mg; and >80 kg, 0.2 mg/kg) Fluoxetine intervention group: in this group, in addition to the standard treatment, the participants in this group will receive 20mg capsules daily. ivermectin + fluoxetine intervention group: in this group, in addition to the standard treatment, the participants in this group will receive 20 mg of fluoxetine capsules daily and ivermectin (48 to 50 kg, 9 mg; 51 to 80 kg, 12 mg; and >80 kg, 0.2 mg/kg) daily Control group: Participants in this group will receive only standard treatment according to the guidelines of the Ministry of Health. Hospitalization. Timepoint: before the start of the study and 5 days after the start of the study. Method of measurement: questionnaire. Development of symptoms. Timepoint: before the start of the study and 5 days after the start of the study. Method of measurement: questionnaire. Fasa University of Medical Sciences Approved 2022-08-24 Fasa university of medical science ethics committee Ebn Sina square Fasa Fars Iran (Islamic Republic of)