Protocol summary

Study aim
Evaluating the efficacy and safety of Ivermectin in the treatment of COVID-19 patients: A double-blind randomized controlled trial, phase II
Design
Randomize double blind clinical trial, with control group, with a sample size of 60 people, with parallel groups, Phase 2 of Clinical trial
Settings and conduct
The place of the study is Razi hospital and Sina hospital, Ahvaz university of medical science, simple sampling of patients with random allocation , double blind clinical trial, used drug and placebo, supervisor and participants are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age ≥18 years, Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19, Hospitalized, Satisfaction to participate in the study, Acceptance of non-participation in another study before the 28th day of the study. Exclusion criteria: Patients with a history of allergic reaction to Ivermectin Renal dysfunction Liver dysfunction Pregnancy or deciding to get pregnant or breastfeeding
Intervention groups
Intervention group: Receive medication. One ivermectin 14 mg tablet every 12 hours for up to three doses. Control group: placebo received a pill quite similar to Ivermectin every 12 hours up to 3 doses
Main outcome variables
virus polymerase reaction chain, Number of hospitalization days, hospitfever, dyspnea, , cough, chest CT scan, cell blood count, C-reactive protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200404046937N4
Registration date: 2020-08-06, 1399/05/16
Registration timing: registered_while_recruiting

Last update: 2020-08-06, 1399/05/16
Update count: 0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Mehran Varnaseri ghandali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7446
Email address
varnaseri-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-30, 1399/05/09
Expected recruitment end date
2020-08-30, 1399/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy and safety of Ivermectin in the treatment of COVID-19 patients: A double-blind randomized controlled trial, phase II
Public title
Evaluating the effect of Ivermectin on covid 19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19 Hospitalized Satisfaction to participate in the study Acceptance of non-participation in another study before the 28th day of the study
Exclusion criteria:
Patients with a history of allergic reaction to Ivermectin Renal dysfunction Liver dysfunction Pregnancy or deciding to get pregnant or breastfeeding
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit and randomization tools are statistical software, make a random sequence is by using statistical software allocation concealment is by assigning unique codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: Supervisor and the participants are blind to the prescription drug of the target group and the control group.The drug in both groups is exactly the same in pill form and is in exactly the same packages. The packages are distinguished only by mentioning the number and the list of numbers will be at the disposal of the statistical consultant and then the data will be analyzed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ethics committee, main building, Ahvaz jundishapur university of medical science, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6133744151
Approval date
2020-06-26, 1399/04/06
Ethics committee reference number
IR.AJUMS.REC.1399.322

Health conditions studied

1

Description of health condition studied
COVID 19
ICD-10 code
U07.1
ICD-10 code description
Corona virus infection, unspecified

Primary outcomes

1

Description
Viral diagnostic test
Timepoint
The first day of the study
Method of measurement
Polymerase chain reaction

2

Description
Duration of hospitalization
Timepoint
Time of dyscharge
Method of measurement
Patient file

Secondary outcomes

1

Description
Fever
Timepoint
Daily
Method of measurement
Thermometer

2

Description
Respiratory rate
Timepoint
Daily
Method of measurement
Patient file

3

Description
Dyspnea
Timepoint
Daily
Method of measurement
Patients interview and patient file

4

Description
Cough
Timepoint
Daily
Method of measurement
Patients interview and patient file

5

Description
Cell blood count
Timepoint
The first day of the study and the end of the study (7th day)
Method of measurement
Lab test

6

Description
C_reactive protein
Timepoint
The first day of the study and the end of the study (7th day)
Method of measurement
Lab test

7

Description
CT scan
Timepoint
The first day of the study and the end of the study (7th day)
Method of measurement
CT scan set

Intervention groups

1

Description
Intervention group: Patients in the main group will receive the drug of this study after treatment with routine drugs of the disease. Ivermectin tablet is 14 mg, so that the patient will receive one Ivermectin tablet every 12 hours for 3 time and then on the seventh day. Patient symptoms and laboratory data and CT scan will be reviewed
Category
Treatment - Drugs

2

Description
Control group: Patients in the control group will receive placebo after treatment with routine medication, which is quite similar to ivermectin in that the patient will receive one placebo tablet every 12 hours for 3 time, and then on the seventh day the patient's symptoms and Laboratory data and CT scan will be reviewed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital, Ahvaz
Full name of responsible person
Mehran Varnasseri
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnaseri.m@gmail.com

2

Recruitment center
Name of recruitment center
Sina hospital, Ahvaz
Full name of responsible person
Mehran Varnaseri
Street address
Sina hospital, 5th Gandomkar st, Koot abdollah Ave
City
Ahvaz
Province
Khouzestan
Postal code
6155819953
Phone
+98 61 3555 0592
Email
drvarnaseri.m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Main building, Ahvaz jundishapur university of medical science, Golstan
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3311 3815
Email
Badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnasseri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasei.m@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnasseri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnaseri.m@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehran Varnasseri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Razi hospital, Felestin Ave, Amanieh Ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 7446
Email
drvarnasei.m@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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