Early Intervention in COVID-19: Favipiravir Verses Standard Care

Chelsea and Westminster NHS Foundation Trust502 enrolled

Overview

Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.

A prospective, randomised, open label study of the combined use of favipiravir and standard clinical care verses standard clinical care alone. A computer-based software will randomise participants 1:1 to either receive favipiravir and standard medical care or standard medical care alone. The allocated medical regime will commence for 10 days. Research blood, sputum nose swab and urine samples will be collected at baseline, as well as between day 5 and 10, and between day 14 and 28 to enable comparative analyses. A COVID-19 antibody test will also be performed 14-28 days after randomisation. In the event of clinically indicated bronchoscopy taking place within 28 days of consent then additional bronchoscopy washing and brushing samples and paired blood sample will be taken for research purposes If a participant is discharged before one of the latter time points, they will be required to return to hospital (provided they are well enough) for the collection of repeat samples. Participants will be closely monitored whilst taking the study medications. Participants will study exit at subject death or 28 days post-randomisation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

502

Conditions

Coronavirus Infection

Interventions

FavipiravirDRUG

Anti-viral

Standard of care managementOTHER

Standard of care management for COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult participants: Signed informed consent 2. New admission to hospital for period expected to last ≥ 1 night 3. Suspected or confirmed COVID-19 infection Patients are suspected of COVID-19 infection if they have the following: · Influenza like illness (fever ≥37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing). And · Finding from either a chest x-ray or CT suggestive of Covid-19 infection And · Alternative causes are considered unlikely 4. For women to be eligible to enter and participate in the study they should be: of non-child-bearing * potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, * or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of \< 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method. 5. Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose Exclusion Criteria: 1. Pregnant or breast feeding, due to potential teratogenicity 2. Hepatic impairment - (AST or ALT \> 3.5 x upper limit of normal) 3. Presently enrolled in an interventional drug study 4. Unable to take medication via the oral or nasogastric route 5. Known sensitivity Favipiravir

Locations (6)

Grupo Hospitalar Conceição

Porto Alegre, Brazil

Fundação Oswaldo Cruz - Instituto Nacional de Infectologia Evandro Chagas (Fiocruz/INI)

Rio de Janeiro, Brazil

Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran

Mexico City, Mexico

Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital

Hull, United Kingdom

Outcomes

Primary Outcomes

Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first

Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first The seven-category ordinal scale is : 1. Not hospitalised with resumption of normal activities 2. Not hospitalised, but unable to resume normal 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both 6. Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both 7. Death

Time frame: Up to 28 days from randomisation

Secondary Outcomes

Clinical status on a seven-category ordinal scale (Day 7)

Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

Time frame: Day 7 from randomisation

Clinical status on a seven-category ordinal scale (Day 14)

Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

Time frame: Day 14 from randomisation

Overall survival

Survival of patients to end of study

Time frame: 28 days from randomisation

Time to improvement by two points on the NEWS score

Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Time frame: Up to 28 days from randomisation

Data from ClinicalTrials.gov

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