Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra in hospitalized patients with COVID-19
Comparing safety and efficacy of Favipiravir and Kaletra in COVID-19
Design
In this intervention study, 100 patient who have Inclusion criteria will be divided into two groups using block randomization method (n=50 in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen.
Settings and conduct
The design is a clinical trial that will be conducted Emam Khomeini hospital in Ardabil - Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19; Requiring hospitalization; Patient's age between 16 and 100 years; Signed informed consent form; Exclusion criteria: Receiving other antiviral medications; renal failure; HIV; Pregnancy and Lactation.
Intervention groups
Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) followed by Favipiravir 600 mg three times a day for 7 days plus Hydroxychloroquine 200mg two times per day for 7 days. Control group: Group receiving Kaletra plus Hydroxychloroquine regimen. Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by Kaletra(Lopinavir/Ritonavir) 200/50 mg two times a day for 7 days.
Main outcome variables
Mortality, length of stay in hospital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150808023559N20
Registration date:2020-04-11, 1399/01/23
Registration timing:prospective
Last update:2020-04-11, 1399/01/23
Update count:0
Registration date
2020-04-11, 1399/01/23
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra in hospitalized patients with COVID-19
Public title
Efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra in hospitalized patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
Requiring hospitalization
Patient's age between 16 and 100 years
Signed informed consent form
Exclusion criteria:
Receiving other antiviral medications
renal failure
Pregnancy
HIV
Lactation
Age
From 16 years old to 100 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use block randomization methods using variable block size of four stratified .
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
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
ARDABIL
Province
Ardabil
Postal code
5615783134
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.ARUMS.REC.1399.012
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
Death
Timepoint
At the time of discharge from the hospital
Method of measurement
Patient medical records
Secondary outcomes
1
Description
Hospital stay
Timepoint
End of intervention
Method of measurement
Patient medical records
Intervention groups
1
Description
Intervention group: Group receiving Favipiravir (Nafas farmed Co, Iran) plus Hydroxychloroquine (Iran daroo Co, Iran). This group will receive stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) followed by Favipiravir 600 mg three times a day for 7 days plus Hydroxychloroquine 200mg two times per day for 7 days.This regimen could be continued for 10 days if necessary according to clinical response of the patient. Other supportive and routine care will be the same in both groups.
Category
Treatment - Drugs
2
Description
Control group: Group receiving Kaletra (Bakhtar bioshimi Co, Iran) plus Hydroxychloroquine (Iran daroo Co, Iran) regimen. This group will receive Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by Kaletra(Lopinavir/Ritonavir) 50/200 mg two times a day for 7 days,This regimen could be continued for 10 days if necessary according to clinical response of the patient. Other supportive and routine care will be the same in both groups.