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IRCT20190417043295N2 IRCT 2021-09-20 Ahvaz University of Medical Sciences Evaluation of the effect of ivermectin in intubated patients 19 Evaluation of the effect of adding ivermectin to standard therapies on the outcome of intubated Covid-19 patients under ventilator 2021-09-23 anticipated 40 Complete https://irct.ir/trial/57603 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method : Block randomization with blocks with size 4, Randomization unit: Individual, Randomization tool: Random, Allocation Software How to make a random sequence: Random sequence is generated using the software, Hide method: (allocation concealment) The matte envelope method is used to hide the random sequence, Blinding description: The patient is not conscious due to the condition and does not know the type of medication received and the statistical analyzer will analyze the information under the headings of groups A and B and will be unaware of which group received which medication. 3 COVID-19, virus not identified. Intervention 1: Intervention group:In addition to the drugs prescribed according to the national protocol, Receiving Ivermectin, 6 mg twice daily on the first day and 3 mg twice daily on the second to fifth day, Gavage every 12 hours, 6 mg tablet (Alborz Daru). Intervention 2: Control group: In addition to the drugs prescribed according to the national protocol, placebo is taken orally in the form of a drug similar to ivermectin (starch tablets), By gavage every 12 hours, the equivalent volume of the ivermectin group for 5 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the nature of Covid disease, a decision is made after submitting the final report to the research deputy of AJUMS
public Reza Baghbanian
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 3985 baghbanian.r@ajums.ac.ir Ahvaz University of Medical Sciences scientific Reza Baghbanian
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 3985 baghbanian.r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Covid PCR test 19 positive Intubated patient No increase in liver enzymes 18 years no limit Both History of drug allergy Pregnant Women Withdrawal of the patient's family from continuing to participate in the study U07.2 COVID-19, virus not identified Treatment - Drugs Treatment - Drugs Intervention group:In addition to the drugs prescribed according to the national protocol, Receiving Ivermectin, 6 mg twice daily on the first day and 3 mg twice daily on the second to fifth day, Gavage every 12 hours, 6 mg tablet (Alborz Daru) Control group: In addition to the drugs prescribed according to the national protocol, placebo is taken orally in the form of a drug similar to ivermectin (starch tablets), By gavage every 12 hours, the equivalent volume of the ivermectin group for 5 days Mortality rate. Timepoint: 30 days range, Daily from the time the patient enters the study. Method of measurement: Vital sign check in 30 days range. Intubation period. Timepoint: in 30 day range, Daily from the time the patient enters the study. Method of measurement: Visual Observation. Lung Compliance. Timepoint: Daily from the time the patient enters the study. Method of measurement: Calculated based on ventilator data. Ahvaz University of Medical Sciences Approved 2021-07-04 Ethics committee of ŮŽAhvaz jundishapur University of Medical Sciences Azadegan street, Imam khomeini Hospital Ahvaz Khouzestan Iran (Islamic Republic of)