COVID-19 trials registries data warehouse

https://slctr.lk/trials/slctr-2021-017

Chamila Mettananda

chamila@kln.ac.lk

2021-07-04

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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).

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

2

Chamila Mettananda

18

100

Sri Lanka

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

380190

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; o initiation of supplemental O2 o initiation of intravenous/oral dexamethasone o having to transfer to a higher-tier healthcare facilityNumber 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]

Phase 2

[{"arm_notes": "", "treatment_id": 189, "treatment_name": "Beclomethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]