The effect of combined regimen of ivermectin and fluoxetine on the prevention of hospitalization and amelioration of symptoms in mild covid-19 patients

Determining the effect of a combined treatment regimen of fluoxetine and ivermectin on the prevention of hospitalization and improvement of symptoms of mild covid-19 patients Providing an available and practical treatment to prevent exacerbation of symptoms and hospitalization in mild covid-19 patients

This study will be conducted in parallel with the control group, in a three-way blind and randomized manner. Patients will be randomly divided into four groups, which will include 1 control group and three intervention groups that will receive combinations of ivermectin and fluoxetine.

This project will be carried out on eligible patients who refer to Fasa clinics and hospitals and are diagnosed with mild severity of Covid-19. None of the patients, caregivers, researchers, and analysts will have any information on how patients are assigned to groups or the use of drugs. In addition to the beginning of the study, the patient's symptoms will be followed daily until the end of the study and the results will be reported based on statistical analysis.

Patients have a definite diagnosis of Covid-19 and the severity of symptoms is mild. Currently, they do not have confounders such as the use of therapeutic drugs, special health conditions, or special chronic diseases.

1- Control group will receive standard treatment. 2- Ivermectin group, in addition to the standard treatment, will receive daily doses of ivermectin based on weight range (48-50 kg, 9 mg; 51-80 kg, 12 mg; and >80 kg, 0.2 mg/kg) 3- Fluoxetine group, in addition to the standard treatment, will receive 20mg daily. 4- ivermectin + fluoxetine group, in addition to the standard treatment, will receive 20 mg fluoxetine daily and ivermectin like group 2.

hospitalization and development of symptoms

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).

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.

The study will be uploaded as a protocol and preprint

at the end of the statistical analysis

Judicial officers and licensed researchers

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.

academic email

Refer to the ethics committee and obtain the necessary permission to provide data