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

Inhaled beclomethasone in the treatment of early COVID-19: a placebo-controlled, randomized trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2021/017

Enrollment

Unknown

Registered

2021-07-04

Start date

2021-07-05

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19

Interventions

The study will be conducted at COVID-19 residential treatment center, District Hospital Kandana from 5th July 2021. All eligible patients will be included in the trial. 190 Participants will be rando

“experimental arm” and “no intervention arm” stratified for age (< 60 years or ? 60 years) and sex (male or female). Randomisation will be done using random sequence generation in block (4 in a block

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Progression of asymptomatic or mild-moderate COVID19 to severe disease, as defined by: •oxygen saturation < 94% and •needing any one of the following three treatment escalation steps; oinitiation of supplemental O2 oinitiation of intravenous/oral dexamethasone ohaving to transfer to a higher-tier healthcare facility 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]	—

Measure

Time frame

Progression of asymptomatic or mild-moderate COVID19 to severe disease, as defined by: •oxygen saturation < 94% and •needing any one of the following three treatment escalation steps; oinitiation of supplemental O2 oinitiation of intravenous/oral dexamethasone ohaving to transfer to a higher-tier healthcare facility 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]

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Secondary

Measure	Time frame
The means of the time since admission to discharge will be compared in the two groups [14 days from initiation of intervention] The medians of the time to self-reported clinical recovery in days will be compared [14 days from initiation of intervention ] 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] 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]	—

Measure

Time frame

The means of the time since admission to discharge will be compared in the two groups [14 days from initiation of intervention] The medians of the time to self-reported clinical recovery in days will be compared [14 days from initiation of intervention ] 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] 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]

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Countries

Sri Lanka

Contacts

Public ContactChamila Mettananda

Professor in Pharmacology

chamila@kln.ac.lk0112961244

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026