Evaluation the efficacy and safety of Favipiravir made by Shahid Beheshti University of Medical Sciences in comparison with Lopinavir-ritonavir in COVID-19 patients
Evaluation the efficacy and safety of Favipiravir Administration in comparison with Lopinavir-ritonavir in COVID-19 patients
Design
Prospective clinical trial with parallel randomized groups
Settings and conduct
Dr. Masih Daneshvari Hopital
Participants/Inclusion and exclusion criteria
Patients who diagnosed with COVID-19 by RT-PCR test and are over 18 years old. These patients are included if they have oxygen saturation less than 93%, fever more than 72 hours before admission, and bilateral pulmonary infiltration.
Intervention groups
In this study, patients in Favipiravir group receive Favipiravir (Toliddaru-Sobhan Oncology company, Iran) at dose of 1600 mg BID for one day and then 600 mg BID for totally 7 days. In Lopinavir-ritonavir group, patients receive Lopinavir-ritonavir (Heterd company, India) at dose of 200/50 mg two tablets BID for 7 days. The other standard and supportive treatment will be done for both groups similarly.
Main outcome variables
Fever, cough, dyspnea, hospitalization time, changes on lung radiology findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N14
Registration date:2020-04-10, 1399/01/22
Registration timing:registered_while_recruiting
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-05, 1399/01/17
Expected recruitment end date
2020-07-07, 1399/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy and safety of Favipiravir made by Shahid Beheshti University of Medical Sciences in comparison with Lopinavir-ritonavir in COVID-19 patients
Public title
Evaluation the effects of Favipiravir in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmed COVID-19 with RT-PCR
Age over 18 years old
Oxygen saturation < 93%
Fever more than 72 hours before admission
Bilateral pulmonary infiltration
Exclusion criteria:
Chronic kidney Disease
Acute kidney Injury
Pregnancy or breastfeeding
Drug allergy history
Chronic liver disease
Mild phase of COVID-19
Critical phase of COVID-19
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study. 21 blocks including 4 patients generated with online website. In each block, two patients will be assigned to Favipiravir group and two patients will be assigned to Lopinavir-ritonavir 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
2020-03-28, 1399/01/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.011
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Fever
Timepoint
Daily
Method of measurement
Thermometer
2
Description
Cough
Timepoint
Daily
Method of measurement
Observation
3
Description
Dyspnea
Timepoint
Daily
Method of measurement
Observation
Secondary outcomes
1
Description
Hospitalization duration
Timepoint
At admission time and discharge time
Method of measurement
Clinical records
2
Description
Lung radiology changes
Timepoint
At admission time and seven and 14 days later
Method of measurement
Computed tomography
3
Description
Adverse Drug Reaction
Timepoint
Daily
Method of measurement
Observation
4
Description
Virological clearance
Timepoint
At admission time and seven and 14 days later
Method of measurement
Reverse transcription polymerase chain reaction
5
Description
Death
Timepoint
At end of the study
Method of measurement
Medical Record
6
Description
Needs of mechanical ventilation
Timepoint
Daily
Method of measurement
Medical Record
Intervention groups
1
Description
Intervention group: Favipiravir (Toliddaru-Sobhan Oncology company, Iran) at dose of 1600 mg BID for one day and then 600 mg BID for totally 7 days with the standard and supportive care
Category
Treatment - Drugs
2
Description
Control group: Lopinavir-ritonavir (Heterd company, India) at dose of 200/50 mg two tablets BID for 7 days with the standard and supportive care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Payam Tabarsi
Street address
Daraabad, Shahid Bahonar St. (Niavaran), Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
payamtabarsi@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
3rd 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
Hossein Vahidi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St., Intersection of Niyayesh Highway, Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
h.vahidi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor, Clinical Pharmacy Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St., Intersection of Niyayesh Highway, Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Fax
Email
f_dastan@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
Ali Saffaei
Position
Clinical Pharmacy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway., Valiasr Ave.
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
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
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 publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document