A multicenter, open-label, randomized controlled trial to evaluate the efficacy of fluticasone propionate (metered dose inhaler - MDI) added to standard care at early stage of COVID-19 in reducing the incidence of adverse outcomes (any of those following: oxygen therapy, systemic corticosteroids, hospitalization, mechanical ventilation, and mortality) in symptomatic patients either from 18 to 49 years of age with risk factors or older than 50 years.
This study has 2 arms: the standard care group followed the COVID-19 guidelines of the Ministry of Health of Vietnam and the interventional group: Fluticasone propionate MDI with spacer, twice a day for 14 days. The study participants will be monitored via video call from day 1 to day 14, day 21, and day 28 after randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam
RECRUITINGIncidence of adverse outcomes
To evaluate the efficacy of fluticasone propionate MDI added to standard care at an early stage COVID-19 in reducing the incidence of adverse outcomes (oxygen therapy, systemic corticosteroids, hospitalization, mechanical ventilation, and mortality) in symptomatic patients either from 18 to 49-year-old with risk factors or older than 50-year-old.
Time frame: Day 28 after randomization
Duration of isolation based on WHO's criteria
To evaluate the efficacy of fluticasone propionate MDI added to standard care at early stage COVID-19 in reducing duration of isolation bases on WHO's criteria in symptomatic patients either from 18 to 49-year-old with risk factors or older than 50-year-old
Time frame: Day 28 after randomization
The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94%
To evaluate the efficacy of fluticasone propionate MDI added to standard care at an early stage COVID-19 in reducing the incidence of patients with SpO2\<94% in those either from 18 to 49-year-old with risk factors or older than 50-year-old
Time frame: Day 28 after randomization
Self-reported recovery rate
To evaluate the efficacy of fluticasone propionate MDI added to standard care at an early stage COVID-19 in reducing self-reported recovery rate of symptomatic patients either from 18 to 49-year-old with risk factors or older than 50-year-old
Time frame: Day 28 after randomization
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