Inhaled beclomethasone versus placebo in the treatment of, asymptomatic or mild to moderate COVID-19 infection to prevent progression to severe disease in a cohort of Sri Lankans: a randomized trial
Phase 2
- Conditions
- COVID19
- Registration Number
- SLCTR/2021/017
- Lead Sponsor
- Chamila Mettananda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
All consenting males and females above 18 years of age with asymptomatic disease on admission or mild/moderate COVID19 (according to National Institutes of Health criteria) within the first 7 days of symptom onset admitted to District Hospital Kandana with a positive SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test).
Exclusion Criteria
1. Patients refusing consent
2. Age < 18 years
3. Recent use (within 14 days) of inhaled or systemic glucocorticoids
4. Contraindication to beclomethasone
5. Inability to use inhalation device without assistance
6. Patients suffering from psychiatric illnesses lacking the insight to partake fully
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression of asymptomatic or mild-moderate COVID19 to severe disease, as defined by:<br>•oxygen saturation < 94% and <br>•needing any one of the following three treatment escalation steps; <br>oinitiation of supplemental O2 <br>oinitiation of intravenous/oral dexamethasone <br>ohaving to transfer to a higher-tier healthcare facility<br><br>Number of patients progressing to severe disease will be compared in the two groups. Number needed to treat will be calculated using relative risk reduction. [14 days from initiation of intervention]<br>
- Secondary Outcome Measures
Name Time Method The means of the time since admission to discharge will be compared in the two groups [14 days from initiation of intervention]<br>The medians of the time to self-reported clinical recovery in days will be compared [14 days from initiation of intervention ]<br> The mean proportion of days with a fever (temperature of 38 degrees or more) in the first 14 days will be compared between the two groups [ 14 days from initiation of intervention]<br>The means of total viral symptoms score measured using the Common Cold Questionnaire (CCQ) and total score measured using InFLUenza Patient-Reported Outcome Questionnaire (FLUPro) will be compared between the two groups. [14 days from initiation of intervention]<br>