GETAFIX (Glasgow Early Treatment Arm Favipiravir) – a study to compare the effectiveness of adding the antiviral drug favipiravir to standard care in COVID-19 patients, compared with standard care alone

INTERVENTION: On admission to the study (baseline) the following will be collected from patients: 1. Written informed consent 2. Assessment of eligibility criteria 3. Demographic details 4. Nasopharyngeal swab (a swab taken from the nose used for COVID‐19 PCR assessment which gives either “postitive or negative” results, and is also used to measure the viral load which tells us how much virus a patient has) 5. Medical history including assessment of medical co‐morbidities and suitability for potential entry to ICU 6. Documentation of other medications the patient is taking 7. Clinical examination 8. Human chorionic gonadotrophin (HCG) test to rule out pregnancy at trial entry. Results must be obtained and reviewed before randomisation for people of childbearing potential 9. Routine observations of respiratory rate, percentage of Oxygen in the blood, Blood pressure, and temperature, to gauge the current state of health 10. Routine clinical blood tests which will include those required to assess eligibility (full blood count, urea and electrolytes, renal function: creatinine and eGFR, liver function tests, c‐reactive protein and an assessment of clotting) 11. Height and weight to assess the current state of health, by calculation of a BMI which is required for eligibility, and to help understand the distribution of the drug in people of different sizes 12. Pre‐morbid performance status as assessed by WHO criteria to give a longer term indication of the state of health 13. WHO COVID 10 point ordinal severity scale assessment to measures the current severity of COVID CONDITION: COVID‐19 (SARS‐CoV‐2 infection) ; Respiratory ; COVID‐19 (SARS‐CoV‐2 infection) PRIMARY OUTCOME: ; 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; 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 participant is of childbearing potential 8. Able to swallow oral medication SECONDARY OUTCOME: ; 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 days; 4. Pharmacokinetics of favipiravir measured by blood sampling at baseline and 1 days (outpatients), or baseline, 1, 3, 5, 8 and 10 days (inpatients); 5. Mechanisms of resistance, immunological and biometric markers contributing to clinical conditions in COVID‐19 patients measured by blood sampling at baseline (screening), 15, 29, and 60 days (outpatients), or baseline (day 1) and 3, 15, 29, and 60 days (inpatients); 6. Post COVID‐19 health and psycho‐social consequences measured by the COVID‐19 Health and Wellbeing follow up survey at 15, 29, and 60 days;