Study of Ivermectin effectiveness in the treatment of COVID-19 patients
Design
Double-blind, randomized clinical trial with parallel control group, phase 2-3 on 60 patients.
Settings and conduct
The study will be conducted in the coronavirus ward of Razi Hospital in Rasht from April to July 2021. Sealed envelope web-page is used to allocate treatments to the two arms A and B. 60 patients will be placed in 15 blocks of 4. In intervention group (A) they will receive Ivermectin 12 mg/day (Four 3 mg Tablets) orally for 2 days + standard care for 10 days and in control group (B) they will receive (Four 3 mg Placebo tablets) orally for 2 days + standard care for 10 days. Concealment is done using the sealed envelope method.
Participants/Inclusion and exclusion criteria
All Covid-19 patients admitted to the coronavirus ward of Razi Hospital in Rasht for period of April to July 2021.
Conditions for not entering the study: Lack of informed consent, Lack of patient cooperation.
Intervention groups
Intervention group: Ivermectin (Alborz-Daru) 12 mg/day (Four 3 mg Tablets) orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first)
Control group: Four 3 mg Tablets orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first)
Main outcome variables
The time required to improve clinical symptoms and paraclinical measures within 10 days of starting treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200329046892N3
Registration date:2021-03-29, 1400/01/09
Registration timing:prospective
Last update:2021-03-29, 1400/01/09
Update count:0
Registration date
2021-03-29, 1400/01/09
Registrant information
Name
Nematollah Ahangar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0099
Email address
n.ahangar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Ivermectin Effectiveness in treatment process, survival and cure rate of COVID-19 patients: a randomized clinical trial
Public title
Effect of ivermectin in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Covid-19 patients admitted to the coronavirus ward of Razi Hospital in Rasht for period of April to July 2021
Age greater than or equal to 18 years
Patients admitted with the following criteria: fever (oral temperature greater than 37.2 ° C), dry cough, severe tiredness or dyspnea
At least one of the following criteria : positive PCR OR lung involvement on chest X-ray / CT scan
Exclusion criteria:
Lack of informed consent
Lack of patient cooperation
Having pulmonary embolism or intravascular thrombosis
Any major drug interaction between routine patient's drugs with any of the study drugs
Pregnancy and lactation
Simultaneous presence in other research study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
It is a block randomization type and the block with size of 4.
Randomization tool: sealedenvelope.com.
60 patients will be assigned in 15 blocks of 4. In intervention group (A) they will receive Ivermectin 12 mg/day (Four 3 mg Tablets) orally for 2 days + standard care for 10 days and in control group (B) they will receive (Four 3 mg Placebo tablets) orally for 2 days + standard care for 10 days. Concealment is done using the sealed envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants (patients) and medical staff are kept blind to the specificity of study groups (Double-blinded). For this purpose, an independent person from the research team and an Infectious Diseases specialist prescribes the assigned codes to each patient. Efforts will be made to make the drug and placebo by one company to ensure the similarity. Study drugs will be placed in similar packages, and patients will receive pre-arranged interventions in the order in which they enter the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
School of Medicine, Guilan University Complex, 7th Km Tehran Road
City
Rasht
Province
Guilan
Postal code
4199613769
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.GUMS.REC.1399.624
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
virus identified
2
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
virus not identified; Clinically-epidemiologically diagnosed COVID-19; Probable COVID-19; Suspected COVID-19
Primary outcomes
1
Description
The time required to improve clinical symptoms within 10 days of treatment start
Timepoint
Daily from the first day of intervention
Method of measurement
Physical examination
Secondary outcomes
1
Description
Body temperature
Timepoint
Daily from the first day of intervention
Method of measurement
Thermometer
2
Description
Heart rate
Timepoint
Daily from the first day of intervention
Method of measurement
Pulse oxymeter
3
Description
Blood pressure
Timepoint
Daily from the first day of intervention
Method of measurement
Barometer
4
Description
Respiration rate
Timepoint
Daily from the first day of intervention
Method of measurement
Count
5
Description
SPO2
Timepoint
Daily from the first day of intervention
Method of measurement
Pulse-oxy mete
6
Description
Duration of hospitalization
Timepoint
Daily from the first day of intervention
Method of measurement
Record in the patient file
7
Description
Mortality
Timepoint
Daily from the first day of intervention
Method of measurement
Record in the patient file
8
Description
Creatine phosphokinase
Timepoint
Before intervention, Day 5 and Day 10
Method of measurement
International Federation of Clinical Chemistry (IFCC)
9
Description
C reactive protein
Timepoint
Before intervention, Day 5 and Day 10
Method of measurement
Turbidometry
10
Description
Erythrocyte sedimentation rate
Timepoint
Before intervention, Day 5 and Day 10
Method of measurement
Westergren method
Intervention groups
1
Description
Intervention group: Ivermectin (Alborz-Daru) 12 mg/day (Four 3 mg Tablets) orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first)
Category
Treatment - Drugs
2
Description
Control group: Four 3 mg Tablets orally for 2 days + standard care for 10 days or hospital discharge (whichever comes first)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Tofigh Yaghubi
Street address
Sardar Jangal Ave.
City
Rasht
Province
Guilan
Postal code
4199613769
Phone
+98 13 3354 1001
Email
tofigh_yaghubi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Naghipour
Street address
Shahid Siadati Ave.. Namju St.
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Nematollah Ahangar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
School of Medicine, Guilan University Complex, 7th Km Tehran road
City
Rasht
Province
Guilan
Postal code
4199613769
Phone
+98 13 3369 0099
Fax
Email
n.ahangar@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Nematollah Ahangar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
School of Medicine, Guilan University Complex, 7th Km Tehran road
City
Rasht
Province
Guilan
Postal code
4199613769
Phone
+98 13 3369 0099
Fax
Email
n.ahangar@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Nematollah Ahangar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
School of Medicine, Guilan University Complex, 7th Km Tehran road
City
Rasht
Province
Guilan
Postal code
4199613769
Phone
+98 13 3369 0099
Fax
Email
n.ahangar@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data about primary outcome
When the data will become available and for how long
2 months after results published
To whom data/document is available
Researchers
Under which criteria data/document could be used
Requested by authenticated scientific centers and universities
From where data/document is obtainable
Dr. Nematollah Ahangar School of Medicine Email: n.ahangar@gums.ac.ir
What processes are involved for a request to access data/document
Official request signed by highest executive is mandatory. Moreover, acceptable reasons should be noted