The comparisson of the prevalence and the severity of COVID-19 in staff with encounter to the COVID patients in the case and control groups
Design
Two arm parallel-group phase-2 clinical trial with outcome assessment in 320 volunteer staff who encounter with COVID-19 patients divided into case group( use 400 mg/week hydroxychloroquine as prophylaxis) and control group (without any drug)
Settings and conduct
In this study, the staff of Seyedoshohada, Isabnemaryam, Khorshid, and Amin hospitals in Isfahan city who are an encounter with COVID-19 patients divided into the case (weekly use of Hydroxychrolokin for 3 months) or control( without any drugs) groups and follow-up during 6 months. The prevalence of affection or the severity of illness will be compared in the two groups.
Participants/Inclusion and exclusion criteria
Exclusion Criteria
1- Treatment with other antiviral drugs at the same time, except for the drugs prescribed in the national protocol
2 - Concomitant diseases: malignancy, advanced heart failure, cirrhosis, people under dialysis, stroke, Alzheimer's, progressive chronic neurological diseases
3- Evidence of multiorgan failure
4- Pregnancy or lactation
Intervention groups
Case group: the volunteer staff encounter with COVID-19 patients who use the hydroxychloroquine as prophylaxis in the dose of 400 milligrams per week for 3 months
Control group: The staff who encounter with COVID-19 patients without any prophylaxis treatment
Main outcome variables
prevalence of COVID-19 onset; the severity of COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200414047076N1
Registration date:2020-08-01, 1399/05/11
Registration timing:registered_while_recruiting
Last update:2020-08-01, 1399/05/11
Update count:0
Registration date
2020-08-01, 1399/05/11
Registrant information
Name
Elahe Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8006
Email address
elahe.nasri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the efficacy of hydroxychloroquine in the prevention of SARS-COV2 infection in high risk health care workers
Public title
Evaluate the efficacy of hydroxychloroquine in the prevention of SARS-COV2 infection in high risk health care workers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Signing the consent form of high-risk personnel and exposed to the virus
Exclusion criteria:
Treatment with other antiviral drugs at the same time, except for the drugs prescribed in the national protocol
Concomitant diseases: malignancy, advanced heart failure, cirrhosis, people under dialysis, stroke, Alzheimer's, progressive chronic neurological diseases
Evidence of multi-organ failure
Pregnancy or lactation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research Chancelor, Isfahan University of Medical Sciences, Hezarjerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2020-03-29, 1399/01/10
Ethics committee reference number
IR.MUI.MED.REC.1399.0.17
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
covid-19
Primary outcomes
1
Description
The onset of covid-19 infection
Timepoint
Before study and after 3 and 6 months
Method of measurement
Clinical symptoms, Corona PCR, CT scan of the lungs
Secondary outcomes
1
Description
The severity of COVID-19
Timepoint
Before study and after 3 and 6 months
Method of measurement
Clinical feature, CT scan
Intervention groups
1
Description
Case group: The Isfahan educational hospital staff who are at risk of coronavirus receiving 200 mg of hydroxychloroquine tablets (Amin Pharmaceutical Company) orally twice a week for 3 months
Category
Prevention
2
Description
Control group: The Isfahan educational hospital staff who are at risk of corona virus who did not receive hydroxychloroquine tablet
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Elahe Nasri
Street address
Omid hospitl, Farshadi Ave, Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
818491754
Phone
+98 31 3236 8005
Fax
Email
elahe.nasri@yahoo.com
2
Recruitment center
Name of recruitment center
Isabn-e-Maryam hospital
Full name of responsible person
Elahe Nasri
Street address
Shams Abad Ave, Isfehan Town, Isabn-e-Mryam Hospital
City
Isfehan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3233 9012
Email
elahe.nasri@yahoo.com
3
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Elahe Nasri
Street address
Ostandari Ave, Khorshid Haspital
City
Isfehan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3222 2127
Email
elahe.nasri@yahoo.com
4
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Elahe Nasri
Street address
Amin hospital, Ebnesina St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3445 9001
Email
elahe.nasri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Nasri
Street address
Omid Hospital, Motahari street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3233 9873
Email
elahe.nasri@yahoo.com
Grant name
Isfahan Medical Sciences
Grant code / Reference number
199004
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Nasri
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Omid Hospital, Motahari st., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3233 9873
Email
elahe.nasri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
elahe Nasri
Position
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Omid Hospital
City
Isfahan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3236 4131
Email
elahe.nasri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Nasri
Position
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
No. 11, Sajad Ave, Ahmadiye
City
Isfahan
Province
Isfehan
Postal code
8136854691
Phone
+98 31 3233 9873
Email
elahe.nasri@yahoo.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
File
When the data will become available and for how long
6 months later
To whom data/document is available
executor of plan
Under which criteria data/document could be used
Effectiveness of treatment
From where data/document is obtainable
executor of plan
What processes are involved for a request to access data/document
Coordinating with the project manager and the hospital director