Covid19
Conditions
Keywords
COVID19, Fluticasone Propionate, inhaled corticosteroid, ICS
Brief summary
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.
Detailed description
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.
Interventions
DRUGFluticasone Propionate
Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signing consent to participate in the study 2. Having COVID related-symptoms within 5 days prior to randomization 3. Confirmed diagnosis of COVID-19 by rapid antigen test or polymerase chain reaction (PCR) test within 5 days prior to randomization 4. Over 50 years old OR 18-49 years old and have one or more of risk factors for severe COVID-19
Exclusion criteria
1. Pregnant or breastfeeding woman 2. Allergy and/or contraindications to inhaled Fluticasone 3. Current or previous administration of inhaled corticosteroids within the 15 days prior to randomization 4. Current or previous administration of high dose systemic corticosteroids (higher than 3.75 mg dexamethasone/day or equivalent doses of other corticosteroids) and/or anticoagulants etc.. more than or equal to 2 days within 15 days prior randomization, or taking any other antiviral drugs (such as remdesivir, favipiravir, etc..) 5. Indication for start of systemic corticosteroids or oxygen therapy or hospitalization dut to COVID-19 within next 24 hours 6. Already participated in other interventional COVID studies 7. Any conditions for which the investigator believes that the patient should not participate for the benefit of the patient or that would prevent, limit, or distort the evaluation of the study procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse outcomes | Day 28 after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of isolation based on WHO's criteria | Day 28 after randomization | 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 |
| The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94% | Day 28 after randomization | 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 |
| Self-reported recovery rate | Day 28 after randomization | 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 |
Countries
Vietnam
Contacts
Primary ContactTran Thien Quan Vu, Dr
Outcome results
None listed