Reduce the infection with covid-19 and mortality of staff due to covid-19 with favipiravir treatment during the Covid- 19 epidemic.
Design
Thirty people in the intensive care unit who are in direct contact with COVID-positive patients will enter the study and receive medical treatment.
Settings and conduct
Thirty ICU staff who are in direct contact with Covid-19 positive patients have been studied and given Favipiravir 200 twice a day for three days a week for two weeks, and the serological test will be checked three weeks later.
Participants/Inclusion and exclusion criteria
inclusion criteria: ICU staff of Masih Daneshvari Hospital - over 20 years old
exclusion criteria: Sensitivity to antiviral drugs and unwillingness to participate in the study
Intervention groups
Treatment personnel who are in direct contact with COVID-positive patients will be treated with Favipiravir three times a week for two consecutive weeks for prevention.
Main outcome variables
Infection of COVID_ 19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N30
Registration date:2020-07-10, 1399/04/20
Registration timing:registered_while_recruiting
Last update:2020-07-10, 1399/04/20
Update count:0
Registration date
2020-07-10, 1399/04/20
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
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
Favipiravir prophylactic to reduce the involvement of health care workers in the COVID-19 epidemic
Public title
Prophylactic Favipiravir for Healthcare Workers in COVID-19 Pandemic
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 20 years
Nurses in the intensive care unit
Satisfaction with entering the plan
Exclusion criteria:
Sensitivity to antiviral drugs
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
End of Niavaran, Darabadational , Research and Treatment center.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-03-31, 1399/01/12
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.021
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
covid19 disease
Primary outcomes
1
Description
infection with Covid 19
Timepoint
Three weeks after starting treatment
Method of measurement
Nasal swap prc covid-19
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Thirty people in the intensive care unit who are in direct contact with COVID-positive patients have been studied and given Favipiravir 200 twice a day for three days a week for two weeks,
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti university of medical sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Seyed Mohammad Reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
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
All patient information can be published after deleting the name
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All professors of medical universities in the country
Under which criteria data/document could be used
If the professors present their proposal and letter from their university by sending a message to Dr. Hashemian's e-mail, they will send their e-mail request and the names and numbers of the patients will be deleted and their questionnaires, data and analysis will be sent to their e-mails.
From where data/document is obtainable
professor hashemian in masih daneshvari hospital
What processes are involved for a request to access data/document
The applicant will be emailed to you after emailing your request and after reviewing their circumstances within one month of requesting the information