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IRCT20180612040068N1 IRCT 2021-04-19 Shiraz University of Medical Sciences To study the effect of Metronidazole and Ivermectin in hospitalized patients with COVID-19. To study the effect of Metronidazole and Ivermectin in the recovery of the infected patients with COVID-19 compared with protocol treatment: triple-blind randomized clinical trial 2021-03-05 anticipated 135 Complete https://irct.ir/trial/54625 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block random allocation Three therapies and six houses blocks In each step when a new block is selected, we select one of the 6 blocks by rolling the dice, Blinding description: Both Ivermectin and Metronidazole, and the control group's drug are labeled as A, B and C, and are unknown to the patient and therapist (Allocation Concealment). Prescription of the medicine to the patients in each group will be ordered by a third person, preferably an epidemiologist. 3 Coronavirus infection. Intervention 1: The first intervention group is the patients that will intake 0.2 mg / kg body weight daily Ivermectin orally (3 mg tablets) as a single dose. Intervention 2: Control group will receive only standard treatment. ( protocol-based drugs) Medication does not interfere with meals. Intervention 3: The second intervention group is the patients that will intake 8 mg/kg body weight of metronidazole up to a maximum of 500 mg every 12 hours for 7 days. Yes - There is a plan to make this available What will be shared: Some of the information, such as the consequences of the study after coding and printing the article, can be shared When: The second half of the year 2021 To whom: Researchers from other medical universities Conditions: Use for joint studies Where to obtain: Deputy for Research, Shiraz University of Medical Sciences How to obtain: Sending a request letter to the Deputy for Research of Shiraz University of Medical Sciences, then deputy order Comments:
public Hassan Joulaei
School of Medicine, Zand Blvd., Health policy Research Center
Shiraz Iran (Islamic Republic of) 14336-71348 +98 71 3230 5410 joulaei_h@yahoo.com Shiraz University of Medical Sciences scientific Alireza Mirahmadizadeh
School of Public Health, Al-Zahra Street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71348-14336 00987137251001-9 reza13441@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Hospitalized patient with positive corona test 18 years no limit Both Allergic history to Metronidazole or Ivermectin or hypersensitivity reaction to them during trial. pregnant patients COPD Patients suspected to ILD long history of diabetes cirrhotic patients Epileptic patients patients with sever renal failure ang GFR below 20 participating in another RCT B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group is the patients that will intake 0.2 mg / kg body weight daily Ivermectin orally (3 mg tablets) as a single dose. Control group will receive only standard treatment. ( protocol-based drugs) Medication does not interfere with meals. The second intervention group is the patients that will intake 8 mg/kg body weight of metronidazole up to a maximum of 500 mg every 12 hours for 7 days. The main consequences of this trial including; the time of disappearance of shortness of breath, the need for oxygen, the reduction of CRP, the normalization of lymphopenia that will be measured by specialists. Also, the effectiveness of each treatment method will be measured based on the length of hospital stay, the likelihood of hospitalization in the ICU, and the likelihood of mortality. Timepoint: Before starting treatment and at the time of discharge, which should not be less than 5 days. Method of measurement: Blood factors with laboratory methods. Temperature with digital thermometer. Blood pressure with mercury sphygmomanometer or digital pulse oximeter. Other cases with direct observation. Shiraz University of Medical Sciences Approved 2020-06-20 Ethics committee of Shiraz University of Medical Sciences Zand Blvd., Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)