Evaluation the efficacy and safety of Hydroxychloroquine administration for COVID-19 post exposure prophylaxis
Design
Randomized clinical trial with control group
Settings and conduct
Loghman Hakim Hospital
Participants/Inclusion and exclusion criteria
In this study, patients who are over 18 years old and had a close contact with a COVID-19 case at least in past 4 days and signed the informed consent form included. Also, pervious cases of COVID-19 and who had flu like symptoms or those with travel history excluded.
Intervention groups
In intervention group, participants receive Hydroxychloroquine (Amin Pharmaceutical company, Isfahan) at dose of 200 mg TDS up to 7 days. In control group, participants receive no medicines. At first of study and at 7 days later, nasopharyngeal specimen will be collect to detect COVID-19.
Main outcome variables
Fever; cough; dyspnea; get infected with COVID-19; death
General information
Reason for update
Acronym
HOPEC
IRCT registration information
IRCT registration number:IRCT20130917014693N10
Registration date:2020-04-08, 1399/01/20
Registration timing:registered_while_recruiting
Last update:2020-04-08, 1399/01/20
Update count:0
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-06-08, 1399/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy and safety of Hydroxychloroquine administration for COVID-19 post exposure prophylaxis
Public title
Evaluation the effects of Hydroxychloroquine administration for COVID-19 prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Close contact with COVID-19 patient at least in past 4 days
sign the informed consent form to participate in study
Exclusion criteria:
Pervious case of COVID-19
Current case of COVID-19
Presenting influenza like symptoms (fever, cough, and sore throat) in last 30 days
Travel history in last 14 days
Lactation and pregnancy
History of arrhythmia
Drug allergy history
Favism history
Chronic liver disease
Chronic kidney disease
Retinopathy history
Weight under 40 kg
Patients who are receiving arritmogenica medicines
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used. A randomized list will be generated by online randomization site. Households will be allocated to case or control group according to the generated list. Then cluster sampling will be done in each group.
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
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.026
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Fever
Timepoint
Daily
Method of measurement
Thermometer
2
Description
Cough
Timepoint
Daily
Method of measurement
Questionnaire
3
Description
Dyspnea
Timepoint
Daily
Method of measurement
Questionnaire
4
Description
Sore throat
Timepoint
Daily
Method of measurement
Questionnaire
5
Description
Myalgia
Timepoint
Daily
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Disease severity
Timepoint
At end of the study
Method of measurement
Clinical scoring for disease severity
2
Description
Death
Timepoint
Day 7, day 14, and day 28
Method of measurement
Observation
3
Description
Adverse reactions
Timepoint
Daily
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Participants receive Hydroxychloroquine (Amin Pharmaceutical company, Isfahan) at dose of 200 mg TDS up to 7 days.
Category
Prevention
2
Description
Control group: Participants receive no medicines.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Minoosh Shabani
Street address
Loghman Hakim Hospital, Kamali St, Makhsoos St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
meinoosh53@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Omidvar Rezaiemirghaed
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Loghman Hakim Hospital, Kamali St, Makhsoos St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
alisaffaei.ss@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
zahra.sahraei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Saffaei
Position
Clinical Pharmacy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
alisaffaei.ss@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after results published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and further analysis
From where data/document is obtainable
Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, Makhsoos St, Tehran
What processes are involved for a request to access data/document