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IRCT20210213050344N1 IRCT 2021-04-06 Shiraz University of Medical Sciences Effectiveness of Ivermectin on Outpatient Treatment of Covid-19 Patients SHIE Investigation of the Effectiveness of Ivermectin on Outpatient Treatment of Covid-19 Patients, Shiraz City, Southern Iran, 2020: A Randomized Controlled Trial Study (RCT) 2021-04-10 anticipated 375 Complete https://irct.ir/trial/54710 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Covid-19 disease. Intervention 1: Intervention group 1: As a single dose, receive 4 tablets of Ivermectin 3 mg on the first day of treatment. M.A. Holder: Jam Tadbir Kala / Tehran, Iran - Manufactured by: Europhartec / France. Intervention 2: Intervention group 2: As a double dose, receiving 4 tablets of 3 mg Ivermectin on the first day and 4 tablets of 3 mg Ivermectin on the second day of treatment. M.A. Holder: Jam Tadbir Kala / Tehran, Iran - Manufactured by: Europhartec / France. Intervention 3: Control group: Receiving 4 placebo tablets on the first day of treatment (made in the laboratory of combined drugs of Shiraz School of Pharmacy). Yes - There is a plan to make this available What will be shared: 1- Random allocation table 2- Patients stratification table based on prognostic factors of age and O2 saturation 3- Excel data table When: 3 months after the publication of the final report / article To whom: People who work in infectious disease management, medical management, and reputable scientific and research centers Conditions: 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 Where to obtain: 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) How to obtain: 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. Comments: 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
public Ali Semati
Zand St., In front of Palestine St., The central building of Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ +98 71 3212 2368 semati.epid77@gmail.com Shiraz University of Medical Sciences scientific Dr. Ali Reza Mirahmadizadeh
Zand St., In front of Palestine St., The central building of Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ +98 71 3212 2368 reza13441@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Clients to selected outpatient treatment centers in Shiraz Only mild symptoms and clinical manifestations (including: fever less than 38 degrees, sore throat with or without dry cough, chills, headache, loss of taste and smell, nausea, vomiting, anorexia, diarrhea, body aches, weakness and Excessive fatigue, persistent yard symptoms) Positive RT-PCR test result Age between 18 and 80 years People with underlying disease (to evaluate the effectiveness of the drug on people with underlying disease) Individuals who have completed and signed the written consent to participate in the project Blood oxygen level 93% and above (O2 sat ≥ 93%) 18 years 80 years Both Pregnant mothers Breastfeeding mothers Severe liver disease Severe kidney disease Severe lung disease HIV Positive patients Chronic obstructive pulmonary disease (COPD) Participate in another RCT Dissatisfaction with participating in the study U07.1 Covid-19 Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: As a single dose, receive 4 tablets of Ivermectin 3 mg on the first day of treatment. M.A. Holder: Jam Tadbir Kala / Tehran, Iran - Manufactured by: Europhartec / France Intervention group 2: As a double dose, receiving 4 tablets of 3 mg Ivermectin on the first day and 4 tablets of 3 mg Ivermectin on the second day of treatment. M.A. Holder: Jam Tadbir Kala / Tehran, Iran - Manufactured by: Europhartec / France Control group: Receiving 4 placebo tablets on the first day of treatment (made in the laboratory of combined drugs of Shiraz School of Pharmacy) The trend of clinical symptoms of Covid-19 disease. Timepoint: Seven time periods on days: Zero, 1, 3, 7, 14, 21 and 28. Method of measurement: Clinical information by completing a qualitative questionnaire and conduct interviews and observations. Blood oxygen level (O2 Saturation). Timepoint: Seven Time Periods on Days: Zero, 1, 3, 7, 14, 21 and 28. Method of measurement: Pulse oximeter device. Hospitalization. Timepoint: Seven time periods on days: Zero, 1, 3, 7, 14, 21 and 28. Method of measurement: Clinical information by completing a qualitative questionnaire and observation. Requires intubation or ICU. Timepoint: Seven time periods on days: Zero, 1, 3, 7, 14, 21 and 28. Method of measurement: Clinical information by completing a qualitative questionnaire and observation. Death. Timepoint: Seven time periods on days: Zero, 1, 3, 7, 14, 21 and 28. Method of measurement: Clinical information by completing a qualitative questionnaire and observation. Shiraz University of Medical Sciences Approved 2021-02-07 Ethics committee of Shiraz University of Medical Sciences Zand St., In front of Palestine St., The central building of Shiraz University of Medical Sciences, Shiraz Shiraz Fars Iran (Islamic Republic of)