Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka
Chamila Mettananda, Chathura Peiris, Dharani Abeyrathna, Aloka Gunasekara, Thimira Egodage, Channaka Dantanarayana, Arunasalam Pathmeswaran, Channa Ranasinha
BMJ Open, doi:10.1136/bmjopen-2023-075803
Objectives To study if early initiation of inhaled beclomethasone 1200 mcg in patients with asymptomatic, mild or moderate COVID-19 reduces disease progression to severe COVID-19. Design Double-blinded, parallel-groups, randomised, placebo-controlled trial. Setting A hospital-based study in Sri Lanka. Participants Adults with asymptomatic, mild or moderate COVID-19, presenting within the first 7 days of symptom onset or laboratory diagnosis of COVID-19, admitted to a COVID-19 intermediate treatment centre in Sri Lanka between July and November 2021. Interventions All participants received inhaled beclomethasone 600 mcg or placebo two times per day, for 10 days from onset of symptoms/COVID-19 test becoming positive if asymptomatic or until reaching primary endpoint, whichever is earlier. Primary outcome measure Progression of asymptomatic, mild or moderate COVID-19 to severe COVID-19. Secondary outcome measures The number of days with a temperature of 38°C or more and the time to selfreported clinical recovery. Results A total of 385 participants were randomised to receive beclomethasone(n=193) or placebo(n=192) stratified by age (≤60 or >60 years) and sex. One participant from each arm withdrew from the study. All participants were included in final analysis. Primary outcome occurred in 24 participants in the beclomethasone group and 26 participants in the placebo group (RR 0.90 ; p=0.763). The median time for selfreported clinical recovery in all participants was 5 days (95% CI 3 to 7) in the beclomethasone group and 5 days (95% CI 3 to 8) in the placebo group (p=0.5). The median time for self-reported clinical recovery in patients with moderate COVID-19 was 5 days (95% CI 3 to 7) in the beclomethasone group and 6 days (95% CI 4 to 9) in the placebo group (p=0.05). There were no adverse events. Conclusions Early initiation of inhaled beclomethasone in patients with asymptomatic, mild or moderate COVID-19 did not reduce disease progression to severe COVID-19. Trial registration number Sri Lanka Clinical Trials Registry; SLCTR/2021/017. ⇒ This is a randomised double-blind adequately powered placebo-controlled trial. ⇒ This study brings evidence from low-middle-income countries and South Asians. ⇒ Patients were recruited irrespective of having symptoms or not. ⇒ Patients were recruited irrespective of their risk of developing complications. ⇒ Patients were randomised irrespective of their vaccination status.
Competing interests None declared. Provenance and peer review Not commissioned; externally peer reviewed.
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'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Double-blinded, '
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'trial.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>A hospital-based '
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'Lanka.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>Adults with '
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'participants received inhaled beclomethasone 600 mcg or placebo two times per day, for 10 '
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'outcome measure</jats:title><jats:p>Progression of asymptomatic, mild or moderate COVID-19 to '
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'measures</jats:title><jats:p>The number of days with a temperature of 38°C or more and the '
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'recovery.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 385 '
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