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IRCT20150808023559N20 IRCT 2020-04-11 Ardabil University of Medical Sciences Efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra in hospitalized patients with COVID-19 Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra in hospitalized patients with COVID-19 2020-04-29 anticipated 100 Complete https://irct.ir/trial/47022 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 stratified . 1-2 COVID-19. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Study results are not yet clear
public Somaieh Matin
Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
ARDABIL Iran (Islamic Republic of) 53141 56198 +98 45 3325 1410 s.matin@arums.ac.ir Ardabil University of Medical Sciences scientific Somaieh Matin
Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
ARDABIL Iran (Islamic Republic of) 5314156198 +98 45 3325 1410 s.matin@arums.ac.ir Ardabil University of Medical Sciences 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 Patient's age between 16 and 100 years Signed informed consent form 16 years 100 years Both Receiving other antiviral medications renal failure Pregnancy HIV Lactation U07.1 COVID-19 Treatment - Drugs Treatment - Drugs 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. 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. Death. Timepoint: At the time of discharge from the hospital. Method of measurement: Patient medical records. Hospital stay. Timepoint: End of intervention. Method of measurement: Patient medical records. Ardabil University of Medical Sciences Approved 2020-04-08 Ethics committee of Ardabil University of Medical Sciences Ardabil University of Medicine Sciences, Daneshgah street, Ardabil ARDABIL Ardabil Iran (Islamic Republic of)