Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
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Protocol summary
The design is a multicenter clinical trial that will be conducted in 10 centers all over the country.
The design is a multicenter clinical trial that will be conducted in 14 centers all over the country.
The design is a multicenter clinical trial that will be conducted in 1014 centers all over the country.
این طرح یک کارآزمایی بالینی چند مرکزی میباشد که در ده مرکز در سطح کشور انجام خواهد شد.
این طرح یک کارآزمایی بالینی چند مرکزی میباشد که در 14 مرکز در سطح کشور انجام خواهد شد.
این طرح یک کارآزمایی بالینی چند مرکزی میباشد که در ده14 مرکز در سطح کشور انجام خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Dr Akram Asghari
Full name of responsible person - Persian: دکتر اکرم اصغری
Street address - English: Shahid Beheshti Boulevard
Street address - Persian: بلوار شهید بهشتی
City - English: Ghoum
City - Persian: شهر قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3719964797
Phone: +98 25 3612 2000
Fax:
Email: akramasghari11@yahoo.com
Web page address:
Name of recruitment center - English: Shahid Beheshti Hospital Name of recruitment center - Persian: بیمارستان شهید بهشتی Full name of responsible person - English: Dr Akram Asghari Full name of responsible person - Persian: دکتر اکرم اصغری Street address - English: Shahid Beheshti Boulevard Street address - Persian: بلوار شهید بهشتی City - English: Ghoum City - Persian: شهر قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 3719964797 Phone: +98 25 3612 2000 Fax: Email: akramasghari11@yahoo.com Web page address:
#2
Name of recruitment center - English: Forghani Hospital
Name of recruitment center - Persian: بیمارستان فرقانی
Full name of responsible person - English: Dr Abolfazl Mozafari
Full name of responsible person - Persian: دکتر ابوالفضل مظفری
Street address - English: Taleghani Street
Street address - Persian: خیابان طالقانی
City - English: Ghoum
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 37158
Phone: +98 25 3133 3000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Forghani Hospital Name of recruitment center - Persian: بیمارستان فرقانی Full name of responsible person - English: Dr Abolfazl Mozafari Full name of responsible person - Persian: دکتر ابوالفضل مظفری Street address - English: Taleghani Street Street address - Persian: خیابان طالقانی City - English: Ghoum City - Persian: قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 37158 Phone: +98 25 3133 3000 Fax: Email: biganeh75@gmail.com Web page address:
#3
Name of recruitment center - English: Kamkar Hospital
Name of recruitment center - Persian: بیمارستان کامکار
Full name of responsible person - English: Dr Javad Khodadadi
Full name of responsible person - Persian: دکتر جواد خدادی
Street address - English: 19 Day Street
Street address - Persian: خیابان 19 دی
City - English: Ghoum
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 37759229
Phone: +98 25 3775 9229
Fax:
Email: biganeh75@yahoo.com
Web page address:
Name of recruitment center - English: Kamkar Hospital Name of recruitment center - Persian: بیمارستان کامکار Full name of responsible person - English: Dr Javad Khodadadi Full name of responsible person - Persian: دکتر جواد خدادی Street address - English: 19 Day Street Street address - Persian: خیابان 19 دی City - English: Ghoum City - Persian: قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 37759229 Phone: +98 25 3775 9229 Fax: Email: biganeh75@yahoo.com Web page address:
Protocol summary
Study aim
Comparing safety and efficacy of Favipiravir and Kaletra in COVID-19
Design
Randomized parallel group, clinical trial, open label
Settings and conduct
The design is a multicenter clinical trial that will be conducted in 14 centers all over the country.
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 such as (Kaletra, Ribavirin, Oseltamivir); Chronic liver or renal failure; HIV; GI bleeding; Pregnancy; Lactation; QT interval > 500 ms.
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
Admission to intensive care unit, In-hopital mortality, length of stay in hospital, Radiological Treatment Response (CT scan), Laboratory Treatment Response (return of blood cell count and CRP values to normal) Fever, Dyspnea, Oxygen saturation after discontinuation of supplemental oxygen for 5 minutes, Oxygen therapy maximum flow during the day (lit/min), and Adverse and allergic drug reactions
General information
Reason for update
Actual trial started one day earlier and more centers added
Acronym
IRCT registration information
IRCT registration number:IRCT20200318046812N1
Registration date:2020-04-01, 1399/01/13
Registration timing:registered_while_recruiting
Last update:2020-04-12, 1399/01/24
Update count:6
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Mostafa Ghanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0067
Email address
mghaneister@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-01, 1399/01/13
Expected recruitment end date
2020-06-02, 1399/03/13
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 on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
Public title
Comparison of the safety and efficacy of Favipiravir and kaletra in 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 because of: Patient's oxygen saturation less than 93% OR
Requiring hospitalization because of: GCS score less than 15 OR
Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR
Requiring hospitalization because of: renal failure (creatinine 1.5 times the previous measurement in the last 7 days OR
Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal)
Patient's age between 16 and 100 years
Signed informed consent form.
Exclusion criteria:
Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...)
Chronic liver failure
Chronic Renal Failure
Patients with acute problems whose survival is expected to be less than 48 hours
HIV patients
A history of gastrointestinal bleeding
Pregnancy and lactation
QT interval exceeds 500 ms
Age
From 16 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
324
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use block randomization methods using variable block size of four and six stratified by center. We will use Excel software and rand() function to generate the random sequence. The master randomization list will be kept by the epidemiologist working wit the research team.
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
Iran university of medical sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.IUMS.REC.1399.065
2
Ethics committee
Name of ethics committee
Baqiyatallah university of medical sciences
Street address
Tehran, Vanak Square, Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-03-26, 1399/01/07
Ethics committee reference number
IR.BMSU.REC.1399.017
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
COVID-19
ICD-10 code description
U07.1 COVID-19
Primary outcomes
1
Description
Admission to intensive care unit
Timepoint
Once (when admitted to intensive care unit)
Method of measurement
Hospital records
Secondary outcomes
1
Description
In-hopital mortality
Timepoint
once
Method of measurement
Patient medical records
2
Description
length of stay in hospital
Timepoint
Once at discharge
Method of measurement
Patient medical records
3
Description
Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area
Timepoint
CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one
Method of measurement
Patient CT scan
4
Description
Laboratory Treatment Response; return of blood cell count and CRP values to normal
Timepoint
Daily
Method of measurement
Laboratory kits
5
Description
Fever
Timepoint
Daily
Method of measurement
Patient medical records
6
Description
Dyspnea
Timepoint
Daily
Method of measurement
Patient medical records
7
Description
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Timepoint
4 times a day while in the wards
Method of measurement
Observation
8
Description
Oxygen therapy maximum flow during the day (lit/min)
Timepoint
Daily
Method of measurement
Patient medical records
9
Description
Allergic drug reaction
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms
10
Description
Adverse drug reactions
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms
Intervention groups
1
Description
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. 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 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. 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
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah university of medical sciences
Full name of responsible person
Dr Behzad Einollahi
Street address
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street