Reducing the incidence of the COVID-19 disease and reducing the hospitalization by taking hydroxychloroquine drug
Design
Clinical trial with control group, with parallel, and randomized groups
Settings and conduct
This study is performed on people who came in close contact with infected patients with COVID-19 who were admitted to medical centers affiliated with Iran University of Medical Sciences. This study is a randomized clinical trial with parallel groups which is done under the supervision of trained nursing experts located in the Endocrine Research Institute of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
People over the age of 40 who have been in contact with a person with COVID-19 disease
Exclusion Criteria:
Pregnancy; Enzymatic disorders caused by certain drugs result in red blood cell lysis (G6PD) ; The history of Retinopathy; Cardiac Arrhythmia
Intervention groups
Experimental group( taking hydroxychloroquine ) and Control group
Main outcome variables
Reducing the incidence of COVID-19; Reducing the hospitalization time in Medical Center ; Decreasing the number of acute symptomatic respiratory patients; Reducing the number of patients with COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042450N4
Registration date:2020-04-16, 1399/01/28
Registration timing:prospective
Last update:2020-04-16, 1399/01/28
Update count:0
Registration date
2020-04-16, 1399/01/28
Registrant information
Name
Mohammad Ebrahim Khamseh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5246
Email address
khamseh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevention of COVID-19 disease after contact with an infected patient with coronavirus after taking hydroxychloroquine in the community
Public title
The effect of hydroxychloroquine to prevent coronavirus disease
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical symptoms including: Fever
Shortness of breath
Cough
Positive Covide test
Typical symptoms on a CT scan
Exclusion criteria:
Hypersensitivity reaction to Hydroxychloroquine
Already taking Chloroquine or Hydroxychloroquine
Cardiac Arrhythmia
Already taking drugs that prolong QT
Decreased renal function in stages 4 and 5.(GFR <30)
The history of enzymatic disorders caused by some drugs that result in red blood cell lysis (G6PD).
The history of Retinopathy
Pregnancy
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using random block method with variable block size. In this method, a number is randomly selected from the numbers 2, 4, 6, and 8. Then, according to the size of the selected block, a random combination of 2 studied treatments is selected. This process is repeated to the extent that a sequence of 1000 of 1 and 2 treatments is created, provided that the number of each of the two treatments is 500. At the time of performance, for each patient, by referring to this list, it is decided which of the two treatments to be assigned to him.
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
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway. Next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.IUMS.REC.1399.076
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
Reduction of incubation time
Timepoint
Daily for 14 days
Method of measurement
Participants' clinical status
2
Description
Reducing the incidence of Symptomatic respiratory disease
Timepoint
14 days after taking hydroxychloroquine
Method of measurement
CT-scan test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: hydroxychloroquine Ruzdarou 200mg; This group take 2 hydroxychloroquine tablet (400 mg) for the first day and From the second day, take one tablet (200 mg) daily for two weeks.
Category
Prevention
2
Description
Control group: Domestic quarantine for 14 days
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Iran University of Medical Science
Full name of responsible person
Mohammad Ebrahim Khamseh
Street address
Firouzeh Street
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۱۶۶۱۵
Phone
+98 21 8894 5246
Email
erc@iums.ac.ir
Web page address
https://ercc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas Motavallian
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2030
Fax
+98 21 8862 2692
Email
ivco@iums.ac.ir
Web page address
https://iums.ac.ir/fa?sid=120
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
The Institute of Endocrinology and Metabolism Research and Training Center
Full name of responsible person
Mohammad Ebrahim Khamseh
Position
The head of Institute
Latest degree
Subspecialist
Other areas of specialty/work
glandulae endocrinae
Street address
Firoozeh Alley, Vali-asr Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8894 5171
Fax
+98 21 8894 5173
Email
khamseh.m@iums.ac.ir
Web page address
https://iem.iums.ac.ir/page/8501/home-page
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Institute of Endocrinology and Metabolism Research and Training Center
Full name of responsible person
Mohammad Ebrahim Khamseh
Position
The Head of Institute
Latest degree
Subspecialist
Other areas of specialty/work
glandulae endocrinae
Street address
Firoozeh Alley, Vali-asr Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
+98 21 8894 5173
Email
khamseh.m@iums.ac.ir
Web page address
https://iem.iums.ac.ir/page/8501/home-page
Person responsible for updating data
Contact
Name of organization / entity
The Institute of Endocrinology and Metabolism Research and Training Center
Full name of responsible person
Fereshteh Abdolmaleki
Position
Research Assistance
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
Firoozeh Alley, Vali-asr Sq,
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
+98 21 8894 5173
Email
fe.abdolmaleki@gmail.com
Web page address
https://ercc.iums.ac.ir/
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