FLuticasone in cOvid Treatment (FLOT)

Study Overview
=================
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.

Official Title
-----------------
A Multicenter, Open-label, Randomized Controlled Trial to Evaluate the Efficacy of Fluticasone Propionate MDI Added to Standard Care at Early Stage of COVID-19 in Reducing the Incidence of Adverse Outcomes in Symptomatic Patients Either From 18 to 49 Year Old With Risk Factors or Older Than 50 Year Old

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Fluticasone Propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signing consent to participate in the study Having COVID related-symptoms within 5 days prior to randomization Confirmed diagnosis of COVID-19 by rapid antigen test or polymerase chain reaction (PCR) test within 5 days prior to randomization Over 50 years old OR 18-49 years old and have one or more of risk factors for severe COVID-19 Exclusion Criteria: Pregnant or breastfeeding woman Allergy and/or contraindications to inhaled Fluticasone Current or previous administration of inhaled corticosteroids within the 15 days prior to randomization 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..) Indication for start of systemic corticosteroids or oxygen therapy or hospitalization dut to COVID-19 within next 24 hours Already participated in other interventional COVID studies 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Participants will be monitored via video call twice a day without any specific drugs. | |
| Experimental: Fluticasone propionate with spacer<br>Fluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care | Drug: Fluticasone Propionate<br>* Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days<br>* Other names: Flixotide 125 mcg Evohaler;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID19, Fluticasone Propionate, inhaled corticosteroid, ICS