The goal of this study was to evaluate the effect of adding ivermectin to standard treatments on the outcome of intubated patients under 19-ventilator.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 per 100 patients. Random Allocation Software will be used to randomize the random block method
Settings and conduct
Intubated patients in COVID-ICU , Ahvaz hospitals, after entering the study, are placed in one of two groups receiving ivermectin or control. Patients become blind due not know the type of gavage drug.
Participants/Inclusion and exclusion criteria
All patients who have been admitted to COVID-ICU and have been intubated will be admitted to the study if they meet the conditions for admission and sign a written informed consent form from the patient's relatives. Inclusion criteria: Covid 19 PCR test, intubated patient, no increase in liver enzymes, at least 18 years old. Exclusion criteria: history of drug allergy, pregnant women, patient's refusal to continue participating in the study
Intervention groups
In addition to receiving the drugs prescribed in accordance with the national protocol, ivermectin for patients in the intervention group is started and continues for 5 days from the time the patient enters the intensive care unit (the first day 6 mg twice a day and the second day until Fifth 3 mg twice a day)
In the placebo group, they receive standard treatment with starch gavage
Main outcome variables
30 days Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043295N2
Registration date:2021-09-20, 1400/06/29
Registration timing:prospective
Last update:2021-09-20, 1400/06/29
Update count:0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Reza Baghbanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
baghbanian-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding ivermectin to standard therapies on the outcome of intubated Covid-19 patients under ventilator
Public title
Evaluation of the effect of ivermectin in intubated patients 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid PCR test 19 positive
Intubated patient
No increase in liver enzymes
Exclusion criteria:
History of drug allergy
Pregnant Women
Withdrawal of the patient's family from continuing to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َAhvaz jundishapur University of Medical Sciences
Street address
Azadegan street, Imam khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
61936673111
Approval date
2021-07-04, 1400/04/13
Ethics committee reference number
IR.AJUMS.REC.1400.234
Health conditions studied
1
Description of health condition studied
COVID-19, virus not identified
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
intubation period
Timepoint
in 30 day range, Daily from the time the patient enters the study
Method of measurement
Visual Observation
2
Description
Lung Compliance
Timepoint
Daily from the time the patient enters the study
Method of measurement
Calculated based on ventilator data
Intervention groups
1
Description
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)
Category
Treatment - Drugs
2
Description
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