ABSTRACT
Background: Oral anti-viral therapies are licensed worldwide in COVID-19 but indications and efficacy rates vary. Aims and Objectives: To evaluate the safety and efficacy of oral favipiravir in patients hospitalised with COVID-19. Method(s): We conducted a multi-centre, open-label, randomised controlled trial of oral favipiravir in patients newly hospitalised with COVID-19, in five centres worldwide. 500 participants were randomised 1:1 to receive oral favipiravir (1800 mg twice daily (BD) for one-day;800 mg BD for nine-days) plus standard care (SC), or SC alone. NCT: 04373733. Result(s): Recruitment was performed between May 2020 and May 2021, with 251 patients randomised to favipiravir and 249 to SC. There was no difference in time to recovery in all patients (HR 1 06;95% CI 0 89-1 27;n=499;p=0.52). A faster rate of recovery was observed in patients receiving favipiravir under the age of 60 years (HR 1 35;95% CI 1 06-1 72;n=247, p=0 01). A 66 % improvement in mechanical ventilation free survival was evident in patients under 60-years of age (HR 0 34;95% CI 0 13-0 85;n=247, p=0 02). A non-significant 26 % reduction in mortality was observed in patients receiving favipiravir (favipiravir: 26;SC: 34;p=0 24). No significant differences were observed in serious adverse events (SAE) between arms (favipiravir: 36 in 27 patients;SC: 33 in 27 patients). Conclusion(s): Orally administered favipiravir has a beneficial effect on recovery, and mechanical ventilation freesurvival in patients under 60-years of age, hospitalised with COVID-19. Wider evaluation of anti-viral medications and their potential treatment combinations is warranted in patients with COVID-19.
ABSTRACT
INTRODUCTION: Public health measures to reduce the transmission of COVID-19 have required various changes in life-style, including loss or risk to employment and social isolation. We wished to assess how these measured effected 30-45 year old smokers at risk of COPD participating in the BLF Early COPD cohort study METHODS: At enrolment, participants were aged 30-45 years, tobacco smokers with >10 pack-year smoking history, FEV1=>80% predicted and a BMI < 35kg/m2. Participants were seen face-to-face in clinic pre-COVID. During lock-down, they were posted questionnaires and contacted by telephone. The last clinic visit took place on the 12 March 2020, remote visits took place between 16 April and 28 Sep. 260 individuals at six sites (25 Belfast, 38 Birmingham, 25 Edinburgh, 101 London, 27 Manchester and 44 Nottingham) were asked about smoking habits. The MRC chronic bronchitis questionnaire, COPD Assessment test (CAT), Leicester cough questionnaire, Hospital Anxiety and Depression questionnaire were completed in writing by the participant and returned by post or photographed and returned by email. At enrolment, the post-BD FEV1 was 3.81 (SD 0.8) litres, 101% (11) of GLI predicted. Comparisons were made by paired t-tests and chi-squared tests. RESULTS: Level of anxiety increased from 6.74 (SD 4.4) to 7.37 (SD 4.7, n=233;p=0.010) during lock-down;depression scores increased from 4.30 (3.9) to 5.14 (SD 4.1;n=233;p<0.001). Anxiety increased in 78/233 and depression in 89/233 participants by 2 or more units, 2 units is considered the minimally important (MCID) in bronchiectasis, COPD and ILD (Wynne, 2020) Figure 1 shows that during lock-down, the proportion of participants not smoking increased from 31/259 (12.0%) to 62/259 (23.9%;p<0.001). In those who continued to smoke, cigarettes per day (p=0.59) and rolling tobacco consumption (g/week) (p=0.92) were unchanged. Participants reported less chronic bronchitis defined as “do you bring up phlegm like this on most days (or nights) as much as three months each year”, fell from 83/260 (31.9%) participants to 74/259 (28.6%;p<0.001). CAT scores fell from 10.5 (SD 6.4) to 9.6 (SD 6.3;n=233;p=0.007) and total cough score improved from 18.7 (SD 2.7) to 19.1 (2.6;n=204;p=0.007). CONCLUSIONS: Despite increased anxiety and depression, participants quit smoking and those that continued to smoke, did not smoke more. Respiratory symptoms of chronic bronchitis, cough and CAT scores improved. REFERENCES:Wynne SC, et al. Chron Respir Dis. 2020 Jan-Dec;17:1479973120933292. doi: 10.1177/1479973120933292. .