Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19

• Register: IRCT
• Last refreshed on: 6 October 2020
• Main ID: IRCT20200318046812N1
• Date of registration: 2020-04-01
• Prospective Registration: Yes
• Primary sponsor: Iran University of Medical Sciences
• Public title: Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19
• 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
• Date of first enrolment: 2020-04-01
• Target sample size: 324
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/46783
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr Mostafa Ghanee
• Affiliation: Bagheiat-allah University of Medical Sciences

• Name: Hossein Biganeh
• Affiliation: Bagheiat-allah University of Medical Sciences

Key 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 minimum: 16 years
Age maximum: 100 years
Gender: Both

Health Condition(s) or Problem(s) studied

U07.1

COVID-19.
COVID-19

Intervention(s)

Intervention 1: 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. Intervention 2: 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.

Primary Outcome(s)

Admission to intensive care unit. Timepoint: Once (when admitted to intensive care unit). Method of measurement: Hospital records.

Secondary Outcome(s)

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.

In-hopital mortality. Timepoint: once. Method of measurement: Patient medical records.

Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits.

Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.

Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records.

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.

Allergic drug reaction. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.

Clinical improvement. Timepoint: Daily. Method of measurement: 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.

Oxygen therapy maximum flow during the day (lit/min). Timepoint: Daily. Method of measurement: Patient medical records.

Source(s) of Monetary Support

Bagheiat-allah University of Medical Sciences

Iran University of Medical Sciences

Secondary Sponsor(s)

Bagheiat-allah University of Medical Sciences

Ethics review

Status: Approved
Approval date: 26/03/2020
Contact:

Baqiyatallah university of medical sciences

Status: Approved
Approval date: 30/03/2020
Contact:

Iran university of medical sciences