Efficacy of Favipiravir in managemant of patient with COVID-19
Design
This is a double blind clinical trial study in phase 3 with 114 patients with COVID19 that randomly devided into 2 groups.
Settings and conduct
This is a double blind clinical trial study with114 patients with positive PCR for COVID19 that have referred to Khansari and Valiasr hospital and they are in subgroup 3 of hospitalization.They will be devided into 2 groups (Favipiravir and control)randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with COVID19 referred to Khansari and Valiasr hospital
Patients with COVID19 in subgroup 3 of hospitalization(i.e SPO2 less than 80% or PaO2 less than 60 CmH2O, severe respiratory distress and respiratory rate more than 34 per minute, instable hemodynamic, acid base disturmance, similar to moderate to severe cases)
Exclusion criteria:
Pregnancy
Drug reaction
Deterioration of symptoms after drug usage
Renal failure manifestation
Heart failure manifestation
Intervention groups
Patients in Favipiravir group will be received Favipiravir tablet for 7 days.
Patients in control group will be received placebo (flour tablet) for 7 days.
Main outcome variables
severity of COVID19
General information
Reason for update
Acronym
COVID-19
IRCT registration information
IRCT registration number:IRCT20201028049175N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EVALUATION OF THE EFFECT OF FAVIPIRAVIR ON MANAGEMENT PATIENT WITH COVID-19
Public title
EVALUATION OF THE EFFECT OF FAVIPIRAVIR ON MANAGEMENT PATIENT WITH COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of patients with COVID19 referred to Valiasr and Khansari hospital
All of patients in subgroup 3 of hospitalization
Exclusion criteria:
Patients that present allergic reaction to the drug
Patients with deterioration of symptomps after drug usage
Renal failure manifestation in patients
Heart failure manifestation in patients
Pregnancy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients are blind, as one group will receive Favipiravir and control group will receive flour tablet that is similar to Favipiravir.In addition, data analyser is blind about groups of patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-08-02, 1399/05/12
Ethics committee reference number
IR.ARAKMU.REC.1399.179
Health conditions studied
1
Description of health condition studied
Coronavirus disease 2019 (COVID19)
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Severity of coronavirus 2019
Timepoint
Before prescription of drug and then every day until 7 days
Intervention group: Favipiravir tablet of FUJIFILM company will be given to the patients. The dose is 1600 mg twice daily on first day and days 2–7: 600 mg twice daily.
Category
Treatment - Drugs
2
Description
Control group: Placebo drug (flour tablet) will be given to the patients orally twice daily for 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari hospital
Full name of responsible person
Hossein Sarmadian
Street address
The end of Daneshgah street
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
research@arakmu.ac.ir
2
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Behnam Mahmoudieh
Street address
Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Assistance of research and technology of Arak university of medical science-Dr.Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Behnam Mahmoudieh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
behnammahmoodiyeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Position
lecturer
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
alikamaliir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shamim Valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
sh.valibak@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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