Investigation of the Effectiveness of Ivermectin on Outpatient Treatment of Covid-19 Patients, Shiraz City, Southern Iran, 2020: A Randomized Controlled Trial Study (RCT)

Investigation of the Effectiveness of Ivermectin in Covid Positive Patients Referred to Selected Outpatient Treatment Centers in Shiraz

Study participants are divided into three groups, including; 1) Single-dose intervention group 2) Double-dose intervention group 3) Control group: receiving placebo, n = 125 patients were calculated for each of the groups included in the study. In each group, patients are stratified according to age and blood oxygen level. Phase 3 studies are considered and the dice throwing function and Excel software are used for randomization.

The study was performed in selected outpatient treatment centers of Covid-19 in Shiraz among patients who have mild clinical manifestations, using a randomized trial method with a control group by stratification method and double-blind. Health care providers and study participants will be completely unaware of the type of drug treatment intervention method.

Inclusion criteria: Clients to selected outpatient treatment centers in Shiraz, which have only mild symptoms and clinical manifestations of Covid-19 disease in the age group of 18 to 80 years. Exclusion criteria: Patients with severe clinical signs and symptoms of Covid-19, patients with HIV, patients with severe disease; liver, kidney, lung, and with chronic obstructive pulmonary disease (COPD).

Group 1, Single dose; (4 tab ivermectin on the first day) Group 2, Double dose; (4 tab ivermectin on the first and second day) Group 3, Placebo dose; (4 tab ivermectin on the first day)

Clinical manifestations, need for hospitalization, length of hospital stay, need for oxygen therapy, need to done intubation, and death

Using a Randomized Controlled Trial (RCT) study, with double-blind method and stratified random allocation, is defined for two intervention groups receiving Ivermectin (single dose and double dose) and control group (receiving placebo). Randomization is defined as blocking, person-centered, and stratified random layers. Prior to random allocation, due to the presence of two important factors in the prognosis of the disease, one is age and the other is the severity of the disease, study participants are placed in two age stratify under 55 years and above or equal to 55 years. Then, in each age group, they are divided into two other stratify in terms of disease severity; severe (O2 sat between 93 to 95%) and non-severe (O2 sat above 95%). After determining these four stratify, in each strata, random allocation with Permuted Block Random Allocation will be used to prevent inequality (Imbalance) in number of two intervention groups (single dose and double dose) and a control group (placebo) The blocks are in the form of three therapies (single dose, double dose and placebo) and three rooms. At each stage when a new block is selected, we randomly select one of the 6 blocks by rolling the dice. 1 A B C 2 A C B 3 B A C 4 B C A 5 C A B 6 C B A Single-dose intervention of Ivermectin is marked with (A) Intervention of two doses of Ivermectin is marked with (B) The control group (placebo) is marked with (C) Drug allocation interventions are unknown to the patient and therapist (allocation concealment). The order of administration of the drug to patients by another person, preferably by an epidemiologist.

Using a Randomized Controlled Trial (RCT) study, with double-blind method, Ivermectin and placebo, which are the same in shape, color, size and number, are labeled in similar packages with the letters B, A and C. According to the researcher's design, labeled drug packages are assigned to patients by physicians and health care providers of selected Covid-19 outpatient treatment centers. Therefore, none of the service providers and patients will be aware of the type of drug prescribed.

1- Random allocation table 2- Patients stratification table based on prognostic factors of age and O2 saturation 3- Excel data table

3 months after the publication of the final report / article

People who work in infectious disease management, medical management, and reputable scientific and research centers

In order to prepare results separate from the results obtained from this research and the relevant article, as well as conducting another analysis and research

1- Via the postal address: Zand St., In front of Palestine St., The central building of Shiraz University of Medical Sciences. Postal code: 14336 - 71348 2- By sending an email to: semati.epid77@gmail.com 3-Through direct follow-up with Mr. Ali Semati, Expert in charge of technical deputy of Shiraz University of Medical Sciences (contact number: 09177131825- 07132122368)

By conducting official correspondence with a numbered and stamped letter from a reputable scientific center / a university center, to the president or Vice Chancellor for Research of Shiraz University of Medical Sciences and after approval: Dean of the University / Vice Chancellor for Research of Shiraz University of Medical Sciences, Approval of the ethics committee and security of Shiraz University of Medical Sciences.

If the researcher intends to receive the data for a new research and analysis, through; 1- Concluding a memorandum / agreement with the Vice Chancellor for Health of Shiraz University of Medical Sciences 2- Full observance of the principles and standards of ethics in research 3- Personal data and information of individuals "only without disclosing important personal information" including; name, national number and ID number will be provided 4- Considering the intellectual rights of the research and development team of this research in Shiraz University of Medical Sciences