Protocol summary
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Study aim
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Comparing safety and efficacy of Favipiravir and Kaletra in COVID-19
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Design
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Randomized parallel group, clinical trial, open label
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Settings and conduct
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The design is a multicenter clinical trial that will be conducted in 20 centers all over the country.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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) , Clinical improvement, 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
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Reason for update
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Announcing the Trial completion date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200318046812N1
Registration date:
2020-04-01, 1399/01/13
Registration timing:
prospective
Last update:
2020-09-19, 1399/06/29
Update count:
6
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Registration date
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2020-04-01, 1399/01/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-01, 1399/01/13
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Expected recruitment end date
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2020-06-02, 1399/03/13
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Actual recruitment start date
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2020-04-02, 1399/01/14
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Actual recruitment end date
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2020-08-03, 1399/05/13
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Trial completion date
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2020-08-20, 1399/05/30
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Scientific title
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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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Public title
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Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 16 years old to 100 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
324
Actual sample size reached:
424
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-30, 1399/01/11
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Ethics committee reference number
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IR.IUMS.REC.1399.065
2
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Ethics committee
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Approval date
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2020-03-26, 1399/01/07
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Ethics committee reference number
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IR.BMSU.REC.1399.017
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Admission to intensive care unit
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Timepoint
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Once (when admitted to intensive care unit)
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Method of measurement
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Hospital records
Secondary outcomes
1
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Description
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In-hopital mortality
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Timepoint
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once
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Method of measurement
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Patient medical records
2
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Description
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length of stay in hospital
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Timepoint
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Once at discharge
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Method of measurement
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Patient medical records
3
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Description
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Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area
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Timepoint
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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
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Method of measurement
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Patient CT scan
4
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Description
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Laboratory Treatment Response; return of blood cell count and CRP values to normal
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Timepoint
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Daily
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Method of measurement
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Laboratory kits
5
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Description
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Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
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Timepoint
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4 times a day while in the wards
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Method of measurement
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Observation
6
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Description
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Oxygen therapy maximum flow during the day (lit/min)
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Timepoint
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Daily
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Method of measurement
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Patient medical records
7
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Description
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Allergic drug reaction
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Timepoint
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Daily
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Method of measurement
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Adverse Drug Reaction forms
8
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Description
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Adverse drug reactions
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Timepoint
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Daily
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Method of measurement
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Adverse Drug Reaction forms
9
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Description
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Clinical improvement
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Timepoint
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Daily
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Method of measurement
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One of the following may happen to the patient: Oxygen saturation reaches above 93% and stays above 93%, the patient does not need oxygen therapy and stays in the same position, discharge by the treating physician
Intervention groups
1
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Description
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Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) and stat dose of two 200mg Hydroxychloroquine tablets (total 400 mg) followed by Favipiravir 600 mg three 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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Deidentified IPD related to outcome will be shared.
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When the data will become available and for how long
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The access period will begin 6 months after publication of the paper
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To whom data/document is available
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The data will be available only for academic researchers.
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Under which criteria data/document could be used
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Only meta-analysis in collaboration with the current study research team will be permitted.
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From where data/document is obtainable
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Researchers can request data by emailing Dr. Mustafa Qanei (mghaneister@gmail.com) or Dr. Mehdi Bagheri (mbagheri.pharm@gmail.com).
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What processes are involved for a request to access data/document
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Requested data will be sent by email after consideration and approval by the relevant authorities from Baghiattallah university.
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Comments
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