Evaluating the efficacy of ivermectin in the treatment of COVID-19 patients
Design
Randomized open label clinical trial, with two arms with 1: 1 allocation ratio
Settings and conduct
This study will performe on patients with severe COVID-19 patients admitted to Labbafinejad Hospital in 1401. Patients are divided into groups A and B and receive medication according to the protocol.
Vital signs and laboratory tests of the patients will evaluate by medical team on the first visit. The medical team will then evaluate vital signs, laboratory tests, and overall outcomes by the fifth day of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Laboratory confirmation of COVID-19 virus by RT-PCR or imaging findings consistent with COVID-19, Severe disease (respiratory rate more than 30 per minute, oxygen saturation less than 94%, or pulmonary infiltration more than 50% in both lungs), Age above 18 years, Willingness to participate in this study. This study has no exclusion criteria.
Intervention groups
Group A, in addition to standard treatment, receives oral ivermectin 200 micrograms per kilogram of body weight for the first and third days of treatment. Group B, in addition to standard treatment, receive oral ivermectin at the same dose for the first, third, and fifth days of treatment.
Main outcome variables
Mortality and intubation requirement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210901052358N4
Registration date:2022-04-13, 1401/01/24
Registration timing:prospective
Last update:2022-04-13, 1401/01/24
Update count:0
Registration date
2022-04-13, 1401/01/24
Registrant information
Name
Amirreza Keyvanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4483 1899
Email address
amirrezakeyvanfar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy of Ivermectin in the Treatment of COVID-19 Patients
Public title
Efficacy of Ivermectin in the treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmation of COVID-19 virus by RT-PCR or imaging findings consistent with COVID-19
Severe disease (respiratory rate more than 30 per minute, oxygen saturation less than 94%, or pulmonary infiltration more than 50% in both lungs)
Age above 18 years
Willingness to participate in this study
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Ethics in Biomedical Research, Shahid Beheshti University of Medical Sci
Street address
Shahid Beheshti University of medical sciences, Arabi St., Daneshjoo Blvd,. Yaman St,. Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.701
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Mortality
Timepoint
5th day of hospitalization
Method of measurement
Patient medical record
2
Description
Intubation requirement
Timepoint
5th day of hospitalization
Method of measurement
Patient medical record
Secondary outcomes
1
Description
Oxygen saturation
Timepoint
First and fifth days of hospitalization
Method of measurement
Pulse oximeter
2
Description
Respiratory rate
Timepoint
First and fifth days of hospitalization
Method of measurement
Physical examination by physician
3
Description
Serum CRP level
Timepoint
First and fifth days of hospitalization
Method of measurement
Laboratory report
4
Description
Lymphocyte count
Timepoint
First and fifth days of hospitalization
Method of measurement
Laboratory report
Intervention groups
1
Description
Intervention group: Group A, in addition to standard treatment, receives oral ivermectin 200 micrograms per kilogram of body weight for the first and third days of treatment. Standard treatments include serum therapy, vitamins, supplemental oxygen, and remdesivir (200 mg intravenously for first day and 100 mg daily intravenously for the next 4 days).
Category
Treatment - Drugs
2
Description
Intervention group: Group B, in addition to standard treatment, receives oral ivermectin 200 micrograms per kilogram of body weight for the first, third, and fifth days of treatment. Standard treatments include serum therapy, vitamins, supplemental oxygen, and remdesivir (200 mg intravenously for first day and 100 mg daily intravenously for the next 4 days).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Amirreza Keyvanfar
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
amirrezakeyvanfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?