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SLCTR Registration Number
SLCTR/2021/017
Date of Registration
The date of last modification
Dec 04, 2023
View original TRDS
Trial Status
Scientific Title of Trial
Inhaled beclomethasone in the treatment of early COVID-19: a placebo-controlled, randomized trial
Public Title of Trial
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
Disease or Health Condition(s) Studied
COVID19
Scientific Acronym
none
Public Acronym
none
Brief title
Inhaled beclomethasone in the treatment of early COVID-19
Universal Trial Number
U1111-1267-4847
Any other number(s) assigned to the trial and issuing authority
P/59/06/2021 -Ethics review committee, Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
Is inhaled dry powder beclomethasone 1200 mcg per day, effective in reducing progression of asymptomatic or mild-moderate COVID-19 to severe disease?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
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 randomized to each arm; “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) randomisation with a 1:1 ratio. Patients will receive beclomethasone or the placebo in addition to usual care.
Experimental arm: Beclomethasone, 600 mcg (one 400 mcg and one 200 mcg capsule), via dry powder inhaler, twice a day for 14 days or until primary outcome is achieved or discharged from the facility.
No intervention arm: Placebo 2 capsules ( 25 mg lactulose each) via dry powder inhaler, twice a day for 14 days or until primary outcome is achieved (in matching capsules) or discharged from the facility.
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
Primary outcome(s)
|
1.
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; 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 ] |
Secondary outcome(s)
|
1.
The means of the time since admission to discharge will be compared in the two groups |
[ 14 days from initiation of intervention ] |
|
2.
The medians of the time to self-reported clinical recovery in days will be compared |
[ 14 days from initiation of intervention ] |
|
3.
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 ] |
|
4.
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 ] |
Target number/sample size
380 (190 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-07-05
Anticipated end date
2021-12-31
Date of first enrollment
2021-07-13
Date of study completion
2021-10-25
Recruitment status
Complete: follow up complete
Funding source
self-funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-06-22
Approval number
P/59/06/2021
Details of Ethics Review Committee
| Name: | Ethics review committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO box 6, Faculty of Medicine Thalagolla road Ragama |
| Telephone: | 0714816310 |
| Email: | chamila@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Chamila Mettananda
Professor in Pharmacology
PO box 6, Faculty of Medicine
Thalagolla road
Ragama
0112961244
0714816310
+94 11 2958337
chamila@kln.ac.lk
http://www.kln.ac.lk
Contact Person for Public Queries
Chamila Mettananda
Professor in Pharmacology
PO box 6, Faculty of Medicine
Thalagolla road
Ragama
0112961244
0714816310
+94 11 2958337
chamila@kln.ac.lk
http://www.kln.ac.lk
Primary study sponsor/organization
Chamila Mettananda
Professor in Pharmacology
Faculty of Medicine - University of Kelaniya
Thalagolla Road, Ragama, Sri Lanka.
0112961244
0112958337
chamila@kln.ac.lk
http://www.kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
2021-10-25
Final sample size
Date of first publication
Link to results
Brief summary of results
