Patients with new type of coronavirus (SARS-CoV-2) infection proven by RT-PCR test with mild pneumonia. MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AVIGAN Tablets 200 mg
Product Name: AVIGAN
Pharmaceutical Form: Tablet
Sponsors
Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 74 years (at the time of informed consent) 2) Gender: Male or female 3) Patients who meet all of the following criteria 1), 2), and 3) at the time of enrolment o Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT-PCR test o Patients with new lung lesions on chest images o Patients with a fever of 37.5°C or more 4) For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug 5) Patients who understand the contents of this study and are able to provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Fever (37.5°C) more than 10 days after the onset of fever 2) Patients with SpO2 less than 95% without oxygen therapy 3) Patients who show increased procalcitonin levels before the start of study drug administration or are suspected to have concurrent bacterial infection 4) Patients with suspected concomitant fungal infections prior to initiation of study drug. 5) Patients with concurrent congestive heart failure (NYHA III-IV) 6) Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification 7) Patients with renal impairment requiring dialysis 8) Patients with disturbed consciousness such as disturbed orientation 9) Pregnant or possibly pregnant patients 10) Female patients who are woman of childbearing potential and unable to consent to the use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation. 11) Male patients who are unable to consent to the use of the barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm from the start up until 90 days after the end of favipiravir administration. 12) Female patients who intend to breastfeed from the start of favipiravir administration until 7 days after discontinuation of favipiravir administration 13) Patients with hereditary xanthinuria 14) Patients who have previously been diagnosed with hyperuricemia (> 1 mg/dL) or xanthine urinary calculi 15) Patients with a history of gout or on treatment for gout or hyperuricemia 16) Patients receiving immunosuppressants 17) Patients who have received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 9 days after fever onset (37.5°C or more) 18) Patients in whom this episode of infection is a recurrence or a reinfection with the SARS-CoV-2 infection 19) Patients who have previously received favipiravir (T-705a) 20) Other patients judged ineligible by the investigator, sub-investigator, or assigned physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify that the efficacy of favipiravir exceeds that of the actual supportive care (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) with mild pneumonia, using the time required to improve clinical symptoms as the primary endpoint;Secondary Objective: Not applicable;Primary end point(s): Time to improvement in body temperature, SpO2, chest imaging findings and negative SARS-CoV-2.;Timepoint(s) of evaluation of this end point: Days 4,7,10,13,16,19,22,25,28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Changes in patient status on a 5-point scale (2) Changes in the level of SARS-CoV-2 viral genome (3) SARS-CoV-2 virus genome clearance rate (4) Duration of pyrexia, (5) Changes in clinical symptoms (6) Changes in NEWS (National Early Warning Score) (7) Changes in chest imaging findings on Days 4,7,10,13,16,19,22,25,28. (8) Percentage of patients requiring adjuvant oxygen therapy and average duration (9) Percentage of patients requiring mechanical ventilation therapy and average duration ;Timepoint(s) of evaluation of this end point: Days 4,7,10,13,16,19,22,25,28. | — |
Countries
Hungary
Contacts
Public ContactCRO
AdWare Research Ltd.
Outcome results
None listed