Created at Source Raw Value Validated value
Oct. 13, 2021, 11:30 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "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. Demographic details 4. Medical history including assessment of medical co-morbidities 5. Documentation of other medications the patient is taking 6. Clinical examination 7. Routine observations 8. Routine clinical blood tests 9. 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 10. Pre-morbid performance status as assessed by WHO criteria to give a longer-term indication of the state of health 11. WHO COVID 10 point ordinal severity scale assessment to measures the current severity of COVID-19 12. Assessment of adverse events 13. PK sampling (Favipiravir arm only) Patients will be allocated to either standard care alone (control arm) or standard care + favipiravir (intervention arm) on a 1:1 basis using a minimisation algorithm incorporating a random component. Factors used in the minimisation will be: 1. Age (16 - 50 years; >50 \u2013 70 years; >70 years) 2. <7 days duration of symptoms (yes; no; unknown) 3. Sex (male; female) 4. History of hypertension or currently obese (BMI >30 or obesity clinically evident) 5. COVID ordinal severity score at baseline (2/3; 4) 6. Treating hospital", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"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"}]

Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "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 \u201cpostitive or negative\u201d 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", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]