COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001904-41/GB

Liz-Anne Lewsley

liz-anne.lewsley@glasgow.ac.uk

2020-04-30

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(1) Age 16 or over at time of consent (2) Exhibiting symptoms associated with COVID-19 (3) Positive for SARS-CoV-2 on valid COVID-19 test (4) Point 1, 2, 3, or 4 on the WHO COVID-19 ordinal severity scale at time of randomisation. (Asymptomatic with postiviepositive COVID19 test, Symptomatic Independent, Symptomatic assistance needed, Hospitalized, with no oxygen therapy) (5) Have >=10% risk of death should they be admitted to hospital as defined by the ISARIC4C risk index: https://isaric4c.net/risk (6) Able to provide written informed consent (7) Negative pregnancy test (women of childbearing potential*) (8) Able to swallow oral medication

(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

2

NHS Greater Glasgow and Clyde ; The University of Glasgow

16

100

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

302

(1) Assess the efficacy of favipiravir in addition to standard care in patients with COVID-19 in reducing the severity of disease compared to standard care alone

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]