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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | Participants will be monitored via video call twice a day without any specific drugs. | |
| Fluticasone propionate with spacer | Experimental | Fluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | Day 28 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 28 after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tran Thien Quan Vu, Dr | Contact | +0084934041123 | thienquan@ump.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Thi Tuyet Lan Le, Ph.D., M.D. | tuyetlanyds@gmail.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | Recruiting | Ho Chi Minh City | Vietnam |
Individual participant data collected during the trial, after deidentification.
From Oct 2021 to September 2022.
Researchers who proposed use of data has been approved by a review committee.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 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 |
| 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 | Day 28 after randomization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |