Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka
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....
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e075803.full |
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| author | Chamila Mettananda Arunasalam Pathmeswaran Chathura Peiris Dharani Abeyrathna Aloka Gunasekara Thimira Egodage Channaka Dantanarayana Channa Ranasinha |
| author_facet | Chamila Mettananda Arunasalam Pathmeswaran Chathura Peiris Dharani Abeyrathna Aloka Gunasekara Thimira Egodage Channaka Dantanarayana Channa Ranasinha |
| author_sort | Chamila Mettananda |
| collection | DOAJ |
| description | 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 self-reported 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 self-reported 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. |
| format | Article |
| id | doaj-art-738ca40a6f554e6593a320951bf02b64 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-738ca40a6f554e6593a320951bf02b642025-08-20T03:52:28ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-075803Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri LankaChamila Mettananda0Arunasalam Pathmeswaran1Chathura Peiris2Dharani Abeyrathna3Aloka Gunasekara4Thimira Egodage5Channaka Dantanarayana6Channa Ranasinha71 Department of Pharmacology, University of Kelaniya Faculty of Medicine, Ragama, Western, Sri LankaPublic Health, University of Kelaniya Faculty of Medicine, Ragama, Sri LankaCOVID-19 Intermediate Treatment Centre, Base Hospital, Kandana, Sri LankaDepartment of Pharmacology, University of Kelaniya, Kelaniya, Sri LankaDepartment of Pharmacology, University of Kelaniya, Kelaniya, Sri LankaDepartment of Pharmacology, University of Kelaniya, Kelaniya, Sri LankaDepartment of Pharmacology, University of Kelaniya, Kelaniya, Sri LankaDepartment of Pharmacology, University of Kelaniya, Kelaniya, Sri LankaObjectives 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 self-reported 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 self-reported 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.https://bmjopen.bmj.com/content/13/12/e075803.full |
| spellingShingle | Chamila Mettananda Arunasalam Pathmeswaran Chathura Peiris Dharani Abeyrathna Aloka Gunasekara Thimira Egodage Channaka Dantanarayana Channa Ranasinha Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka BMJ Open |
| title | Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka |
| title_full | Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka |
| title_fullStr | Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka |
| title_full_unstemmed | Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka |
| title_short | Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka |
| title_sort | inhaled beclomethasone in the treatment of early covid 19 a double blind placebo controlled randomised hospital based trial in sri lanka |
| url | https://bmjopen.bmj.com/content/13/12/e075803.full |
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