COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN31062548

Mrs Carol Evans

carol.evans@glasgow.ac.uk

2020-09-07

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Current inclusion criteria as of 11/10/2021: 1. Aged =16 at time of consent 2. Exhibiting symptoms associated with COVID-19 3. Positive for SARS-CoV-2 on valid COVID-19 test 4. Point 2 or 3 on the WHO COVID-19 ordinal severity scale at the time of randomisation (symptomatic independent, symptomatic assistance needed) 5. Able to provide written informed consent 6. Negative pregnancy test if the participant is of childbearing potential 7. Able to swallow oral medication Previous inclusion criteria: 1. Aged =16 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 the time of randomisation (asymptomatic with positive valid COVID19 test, symptomatic independent, symptomatic assistance needed, or 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 if the participant is of childbearing potential 8. Able to swallow oral medication

Current exclusion criteria as of 21/03/2022: 1. Renal impairment requiring, or likely to require, dialysis or haemofiltration 2. Pregnant or breastfeeding 3. Childbearing potential, or, with partners of childbearing potential, who do not agree to the use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment 4. History of acute or chronic gout, or hereditary xanthinuria 5. Judged to be ineligible by the principal investigator or sub-investigator 6. Known hypersensitivity to favipiravir, its metabolites, or its excipients 7. Severe hepatic impairment, defined as > Child-Pugh grade A, AST or ALT >5 x ULN or AST or ALT >3 x ULN and Total Bilirubin >2 x ULN 8. More than 7 days since onset of COVID-19 symptoms 9. Unable to discontinue contra-indicated concomitant medications 10. Eligible to directly access anti-viral or neutralising monoclonal antibody therapies for COVID19, as defined by UK clinical commissioning guidance at the point of assessment _____ Previous exclusion criteria as of 11/10/2021: 1. Renal impairment requiring, or likely to require, dialysis or haemofiltration 2. Pregnant or breastfeeding 3. Childbearing potential, or, with partners of childbearing potential, who do not agree to the 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. Judged to be ineligible by the principal investigator or sub-investigator 6. Known hypersensitivity to favipiravir, its metabolites, or its excipients 7. Severe hepatic impairment, defined as > Child-Pugh grade A, AST or ALT >5 x ULN or AST or ALT >3 x ULN and Total Bilirubin >2 x ULN 8. More than 7 days since onset of COVID-19 symptoms 9. Unable to discontinue contra-indicated concomitant medications (section 6.7) _____ Previous exclusion criteria: 1. Renal impairment requiring, or likely to require, dialysis or haemofiltration 2. Pregnant or breastfeeding 3. Childbearing potential, or, with partners of childbearing potential, who do not agree to the 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. Judged to be ineligible by the principal investigator or sub-investigator 6. Known hypersensitivity to favipiravir, its metabolites, or its excipients 7. Severe co-morbidities including patients with severe hepatic impairment, defined as: greater than Child-Pugh grade A, AST or ALT >5 x ULN, or AST or ALT >3 x ULN and Total Bilirubin >2 x ULN 8. >96 h since first positive COVID19 test sample was taken 9. Unable to discontinue contra-indicated concomitant medications

2

NHS Greater Glasgow and Clyde

16

100

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

302

Current primary outcome measure as of 21/03/2022: Efficacy of favipiravir in addition to standard care in patients with COVID-19 in reducing the severity of disease compared to standard care alone measured using the WHO COVID 10-point ordinal scale score up to and including day 15 _____ Previous primary outcome measure: Efficacy of favipiravir in addition to standard care in patients with COVID-19 in reducing the severity of disease compared to standard care alone measured using the WHO COVID 10-point ordinal scale at 15 days

Phase 2

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