COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AVIGAN
Product Name: AVIGAN
Product Code: Favipiravir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Favipiravir
CAS Number: 259793-96-9
Concentration unit: mg milligram(s)
C
Sponsors
NHS Greater Glasgow and Clyde
The University of Glasgow
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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 Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 239 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: (1) Assess the effect of favipiravir in addition to standard care in the study population compared to standard care alone. (2) Evaluate the safety and tolerability of favipiravir in the study population;Primary end point(s): (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;Timepoint(s) of evaluation of this end point: Clinical status as assessed by WHO COVID 10 point ordinal severity scale at day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Assess the effect of favipiravir in addition to standard care in the study population compared to standard care alone (2) Evaluate the safety and tolerability of favipiravir in the study population ;Timepoint(s) of evaluation of this end point: (1) (a) Proportion of patients meeting level 7 or above on the WHO COVID 10 point ordinal severity scale or dead by day 29 (b) WHO COVID 10 point ordinal severity scale level - days 8, 29, 60 (c) Overall survival - up to and including day 60 (d) In patients only - viral clearance on or before day 8 of treatment - day 8 (e) In patients only - duration of pyrexia in days (define by temperature > 38 degrees C - up to and including day 60 (2) Adverse events - up to and including day 60 | — |
Countries
United Kingdom
Outcome results
None listed