COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Current interventions as of 11/10/2021:
On admission to the study (baseline) the following will be collected from patients:
1. Written informed consent
2. Assessment of eligibility criteria
3. Demogra
>50 – 70 years
>70 years)
2. 30 or obesity clinically evident)
5. COVID ordinal severity score at baseline (2/3
4)
6. Treating hospital
7. Vaccination status
Patients receiving favipiravir will take the drug twice daily: 9 tablets, 12 hours apart on the first day, and 4 tablets, 12 hours apart on days 2-10. Th
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/10/2021: 1. Effect of favipiravir on ICU admission rate measured by proportion of patients =level 7 on the WHO-COVID 10-point ordinal scale up to and including day 29 2. Overall survival, assessed up to and including 60 days 3. Safety and tolerability of favipiravir in the study population measured by assessment of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) v5 at up to and including day 60 4. Effect of favipiravir on SARS-CoV-2 viral clearance, measured by PCR test at day 15, 29 and 60. 5. Pharmacokinetics of favipiravir measured by blood sampling at day 1 pre-dose, and 30 and 90 mins post dose 6. Patient factors (immunological and biometric markers) contributing to clinical conditions in COVID-19 patients measured by blood sampling up to including day 60 7. Post COVID-19 health and psychosocial consequences measured by the COVID-19 Health and Wellbeing follow up survey up to and including day 60. Previous secondary outcome measures: 1. Effect of favipiravir in addition to standard care in the study population compared to standard care alone measured using: 1.1. The WHO COVID 10 point ordinal scale, measured at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 29, and 60 days (measurements on days 1-10 by telephone in outpatients) 1.2. Viral clearance measured from nasopharyngeal swabs at baseline and 8 days 1.3. Overall survival, assessed up to and including 60 days 1.4. Duration of pyrexia by temperature measured in inpatients only, up to and including the day of discharge or 60 days 2. Safety and tolerability of favipiravir in the study population measured by assessment of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) v5 at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 29, and 60 days (measurements on days 1-10 by telephone in outpatients) 3. Effect of favipiravir on the duration of hospitalisation measured by assessment of patient status up to and including 60 day | — |
Countries
Scotland, United Kingdom
Outcome results
None listed