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IRCT20200318046812N1 IRCT 2020-04-01 Iran University of Medical Sciences Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19 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 2020-04-01 anticipated 324 Complete https://irct.ir/trial/46783 interventional 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. 3 COVID-19. 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. Yes - There is a plan to make this available What will be shared: Deidentified IPD related to outcome will be shared. When: The access period will begin 6 months after publication of the paper To whom: The data will be available only for academic researchers. Conditions: Only meta-analysis in collaboration with the current study research team will be permitted. Where to obtain: Researchers can request data by emailing Dr. Mustafa Qanei (mghaneister@gmail.com) or Dr. Mehdi Bagheri (mbagheri.pharm@gmail.com). How to obtain: Requested data will be sent by email after consideration and approval by the relevant authorities from Baghiattallah university. Comments: -
public Hossein Biganeh
Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
Tehran Iran (Islamic Republic of) 1435915371 +98 31 5472 3386 Biganeh75@gmail.com Bagheiat-allah University of Medical Sciences scientific Dr Mostafa Ghanee
Vanak, Mulla Sadra Street, Sheikh Bahaee Street, Nosrat Alley
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8860 0067 mghaneister@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 16 years 100 years Both 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 U07.1 COVID-19 Treatment - Drugs Treatment - Drugs 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. 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. Admission to intensive care unit. Timepoint: Once (when admitted to intensive care unit). Method of measurement: Hospital records. In-hopital mortality. Timepoint: once. Method of measurement: Patient medical records. Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records. 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. Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits. 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. Oxygen therapy maximum flow during the day (lit/min). Timepoint: Daily. Method of measurement: Patient medical records. Allergic drug reaction. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms. Adverse drug reactions. 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. Bagheiat-allah University of Medical Sciences Iran University of Medical Sciences Bagheiat-allah University of Medical Sciences Approved 2020-03-30 Iran university of medical sciences Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2020-03-26 Baqiyatallah university of medical sciences Tehran, Vanak Square, Mulla Sadra Street Tehran Tehran Iran (Islamic Republic of)