Created at Source Raw Value Validated value
Oct. 26, 2020, 7:26 a.m. eu

(1) Renal impairment requiring dialysis or haemofiltration (2) Pregnant or breastfeeding (3) Of child bearing potential* (women), or with female partners of child bearing potential (men) who do not agree to use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment (4) History of hereditary xanthinuria (5) Xanthine urinary calculi (6) Other patients judged ineligibleunsuitable by the Principal Investigator or sub-Investigator (7) Known hypersensitivity to favipiravir, its metabolites or any excipients (8) Severe co-morbidities including : patients with severe hepatic impairment defined as: (greater than Child-Pugh grade A- see (Appendix 4) AST or ALT > 5 x ULN AST or ALT > 3x ULN and Total Bilirubin >2xULN) (9) More than 96 hours since swabfirst positive for COVID19 PCRtest was taken. (10) Unable to discontinue contra-indicated concomitant medications (section 6.7) * Non-childbearing potential must be evidenced by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. Documentation of Iirreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation

(1) Renal impairment requiring dialysis or haemofiltration (2) Pregnant or breastfeeding (3) Of child bearing potential* (women), or with female partners of child bearing potential (men) who do not agree to use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment (4) History of hereditary xanthinuria (5) Xanthine urinary calculi (6) Other patients judged ineligibleunsuitable by the Principal Investigator or sub-Investigator (7) Known hypersensitivity to favipiravir, its metabolites or any excipients (8) Severe co-morbidities including : patients with severe hepatic impairment defined as: (greater than Child-Pugh grade A- see (Appendix 4) AST or ALT > 5 x ULN AST or ALT > 3x ULN and Total Bilirubin >2xULN) (9) More than 96 hours since swabfirst positive for COVID19 PCRtest was taken. (10) Unable to discontinue contra-indicated concomitant medications (section 6.7) * Non-childbearing potential must be evidenced by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. Documentation of Iirreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation