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The prophylactic effect of oral hydroxy-chloroquine in close contacts of COVID-19 patients

Protocol summary

Study aim
Evaluation of the preventive effect of oral administration of hydroxychloroquine tablets in people who were in close contact with patients with COVID-19 disease hospitalized in Bushehr hospitals.
Design
Study group: Cases of this group are treated with preventive treatment of hydroxychloroquine as follows. The control group also uses vitamin B1 tablets, which, in terms of drug form, color and odor, are similar to hydroxychloroquine.
Settings and conduct
After obtaining the consent of the person, he will undergo a clinical trial. In this phase, the clinical trial performer has no knowledge of type of pills(drugs) given to individuals, as well as the individuals themselves, whether they are hydroxychloroquine or a placebo.
Participants/Inclusion and exclusion criteria
Close contact with a person with COVID-19 who has been diagnosed positive with a definitive test.
Intervention groups
After obtaining the consent of the person, he will undergo a clinical trial. In this phase, the clinical trial performer has no knowledge of type of pills(drugs) given to individuals, as well as the individuals themselves, whether they are hydroxychloroquine or a placebo. Control group: The cases of this group are treated with preventive treatment of placebo for 6 days, which are used orally once a day at 22:00. Study group: Cases of this group are treated with preventive treatment of hydroxychloroquine as follows. 1-hydroxychloroquine 400 mg tablet once on the first night at 22:00 2- hydroxychloroquine 200 mg tablet once a night for 5 nights at 22:00 It should be noted that patients will be monitored directly to prevent the effects of disruptive factors. The control group also uses vitamin B1 tablets, which, in terms of drug form, color and odor, are similar to hydroxychloroquine.
Main outcome variables
The prophylactic effect of oral hydroxy-chloroquine in close contacts of COVID-19 patients

General information

Reason for update
Acronym
COVID
IRCT registration information
IRCT registration number: IRCT20200513047426N1
Registration date: 2020-06-27, 1399/04/07
Registration timing: registered_while_recruiting

Last update: 2020-06-27, 1399/04/07
Update count: 0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Ramin Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3424 5286
Email address
drrezaee.ramin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of oral hydroxy-chloroquine in close contacts of COVID-19 patients
Public title
The prophylactic effect of oral hydroxy-chloroquine in close contacts of COVID-19 patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Close contact with a person with COVID-19 who has been diagnosed positive with a definitive test. Close contact: contact, hand shake and talking at least once in the last 2 days for less than 2 meters with COVID-19 patient who have been diagnosed positive with a definitive test. Family, friends, relatives who have been in the same place for a period of 4 hours or more in the last 2 days with a COVID-19 patient who have been diagnosed with a definitive test . Medical staff, including physicians, nurses, midwives, and service personnel which have been in contact with COVID-19 patient who has been diagnosed with a definitive test in the past three days.
Exclusion criteria:
Lack of satisfaction from entered persons The presence of diseases or conditions in which the use of hydroxychloroquine is as a contraindication, such as patients with heart failure who take QT prolonging drugs are as contraindications. Existence of distorting factors during the implementation of clinical trial.+ During the study, people should be in home quarantine . + Do not Excessive use of vitamins and medications.+ has Meals like family’s.+has Regular sleep cycle Complications of hydroxychloroquine based on the Iranian rheumatology association include the following:1- Nausea, decreased appetite and diarrhea 2- Skin allergies 3- Skin discoloration 4- Ocular sensitivity 5- Headache 6- Rush
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 500
Randomization (investigator's opinion)
Randomized
Randomization description
Close contact with a person with COVID-19 who has been diagnosed positive with a definitive test can be known.sample size can be measured by following formula: P ̅=(P_1+P_2)/2 n=(z_(1-α/2) √(2P ̅(1-P ̅ ) )+z_(1-β) √(P_1 (1-P_1 )+P_2 (1-P_2 ) ))/(P_1-P_2 )^2 sample size=500 person Restricted randomization by Random allocation rule
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, main researchers, health care personnel (physicians, nurses, students, etc.) who are responsible for patients care, data collection, and those who evaluate the outcome. Of course, the patient is informed consciously, but is not aware of the nature of the medication he is taking, and assumes that all participants are taking the same medication.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Boshehe University of Medical Sciences
Street address
Moallem Ave
City
Boshehr
Province
Boushehr
Postal code
7518759577
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.BPUMS.REC.1399.017

Health conditions studied

1

Description of health condition studied
Covid19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Percentage of people who have not been diagnosed with Covid19 after co-administration of hydroxychloroquine.
Timepoint
The end of study
Method of measurement
Diagnostic COVID-19 Kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cases of this group are treated with preventive treatment of hydroxychloroquine as follows.1-hydroxychloroquine 400 mg tablet once on the first night at 22:002- hydroxychloroquine 200 mg tablet once a night for 5 nights at 22:00It should be noted that patients will be monitored directly to prevent the effects of disruptive factors.
Category
Prevention

2

Description
Control group: The cases of this group are treated with preventive treatment of placebo for 6 days, which are used orally once a day at 22:00.The control group also uses vitamin B1 tablets, which, in terms of drug form, color and odor, are similar to hydroxychloroquine.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Persian gulf hospital
Full name of responsible person
Dr.Ramin Rezaee
Street address
Moallem Ave
City
Boshehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0235
Email
Drrezaee.ramin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Vice chancellery for research and technology
Street address
Moallem Ave
City
Boshehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
Drrezaee.ramin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Ramin Rezaee
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Moallem Ave
City
Boshehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
Drrezaee.ramin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr.Ramin Rezaee
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Moallem Ave
City
Boshehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
Drrezaee.ramin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr.Ramin Rezaee
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Moallem Ave
City
Boshehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
Drrezaee.ramin@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
not
When the data will become available and for how long
not
To whom data/document is available
not
Under which criteria data/document could be used
not
From where data/document is obtainable
not
What processes are involved for a request to access data/document
not
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