Evaluation of the efficacy of Favipiravir in comparison with standard medication on clinical and laboratory findings of COVID-19 patients with moderate severity
Comparison of the therapeutic effect of Favipiravir with Standard medication in COVID-19 patients with moderate-severity referred to the infectious disease clinic of Labbafinejad hospital in 1400
Design
Phase 3 block randomized, open-lable clinical trial with intervention and control groups (allocation ratio 1:1)
The sample size of each group is considered about 40 .
Settings and conduct
This study was performed on patients with moderate COVID-19 referred to the infectious diseases clinic of Labbafinejad hospital in 2021. Eligible patients, they are divided into two groups of intervention and control using a random number table. The intervention group, in addition to supportive and symptomatic treatment, receives oral Favipiravir (according to the order mentioned above). The control group recieves standard medication. A trained clinical evaluator then reports patients' recovery on days 1 (start of treatment), 3, 5, and 7. Blood tests are also taken from the patient on days 1 and 7. This is an open-lable study.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Laboratory confirmation of COVID-19 virus by RT-PCR or COVID-19 compliant imaging evidence; Moderate-severity disease (respiration rate <30 per minute, oxygen saturation> 94%, or pulmonary infiltration <50% in both lungs); and Age over 14 years.
Exclusion criteria are: Immunocomprimised patients; Consumption of effective drugs in the treatment of COVID-19; and History anaphylaxis.
Intervention groups
The intervention group, in addition to supportive and symptomatic treatment, receives oral Favipiravir at a dose of 1600 mg every 12 hours for the first day and then 600 mg every 12 hours for the next four days. The control group also receives standard medication.
Main outcome variables
Trend of clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052664N1
Registration date:2021-10-06, 1400/07/14
Registration timing:prospective
Last update:2021-10-06, 1400/07/14
Update count:0
Registration date
2021-10-06, 1400/07/14
Registrant information
Name
Afshin Bagherzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2554
Email address
dr.bagherzade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-31, 1400/08/09
Expected recruitment end date
2021-12-30, 1400/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Favipiravir in comparison with standard medication on clinical and laboratory findings of COVID-19 patients with moderate severity
Public title
The therapeutic effect of Favipiravir in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory covfirmation of COVID-19 virus by RT-PCR or imaging findings consistent with COVID-19
Moderate-severity disease (respiratory rate <30 per minute, oxygen saturation > 94% or pulmonaru infiltration < 50% in both lungs)
Age above 14 years
Willingness to participate in this study
Exclusion criteria:
Immunocompromised patients
Pregnancy
Consumption of effective drugs in the treatment of COVID-19 in this clinical course
History of severe hypersensitivity or anaphylactic shock
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).
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
Research ethics committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.SBMU.MSP.REC.1399.750
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms
Primary outcomes
1
Description
Body temperature
Timepoint
Days 1 (start of treatment), 3, 5 and 7
Method of measurement
Thermometer
2
Description
Respiratory rate (per minute)
Timepoint
Days 1 (start of treatment), 3, 5 and 7
Method of measurement
Physical examination by physician
3
Description
Oxygen saturation
Timepoint
Days 1 (start of treatment), 3, 5 and 7
Method of measurement
Pulseoxymeter
Secondary outcomes
1
Description
Hospitalization
Timepoint
Seventh day from the beginning of treatment
Method of measurement
Patient medical record
2
Description
Serum CRP level
Timepoint
Days 1 (start of treatment), 3, 5, and 7
Method of measurement
Laboratory report
3
Description
Lymphocyte count
Timepoint
Days 1 (start of treatment), 3, 5, and 7
Method of measurement
Laboratory report
Intervention groups
1
Description
Intervention group: Patients in the intervention group, in addition to standard medication (serum therapy, analgesics, antipyretic, and vitamine), take oral Favipiravir at a dose of 1600 mg every 12 hours for the first day and then 600 mg every 4 hours for 4 days. Favipiravir used is made by Abidi Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive symptomatic and supportive treatment (analgesic, antipyretic and vitamin) according to the national protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Afshin Bagherzade
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2280
Email
dr.bagherzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St., Shahid Abbas Arabi St. (Parvaneh), Next to Taleghani hospital, Shahid Beheshti University of medical sciences and health services, Headquarters building 2, Floor 5, Deputy of research and technology
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@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
Afshin Bagherzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
No. 2, Habibi Ave., Sajjad Ave., Gholhak, Shariati ST.
City
Tehran
Province
Tehran
Postal code
1941936491
Phone
+98 21 2263 2554
Email
dr.bagherzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Bagherzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
No. 2, Habibi Ave., Sajjad Ave., Gholhak, Shariati ST.
City
Tehran
Province
Tehran
Postal code
1941936491
Phone
+98 21 2263 2554
Email
dr.bagherzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Bagherzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
No. 2, Habibi Ave., Sajjad Ave., Gholhak, Shariati ST.
City
Tehran
Province
Tehran
Postal code
1941936491
Phone
+98 21 2263 2554
Email
dr.bagherzade@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