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FLuticasone in cOvid Treatment (FLOT) (FLOT)

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Fluticasone Propionate
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, Fluticasone Propionate, inhaled corticosteroid, ICS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Medicine and Pharmacy at Ho Chi Minh CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Fluticasone propionate with spacer

Arm Description

Participants will be monitored via video call twice a day without any specific drugs.

Fluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
September 20, 2021
Last Updated
September 21, 2021
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT05054322
Brief Title
FLuticasone in cOvid Treatment (FLOT)
Acronym
FLOT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 22, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID19, Fluticasone Propionate, inhaled corticosteroid, ICS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participants will be monitored via video call twice a day without any specific drugs.
Arm Title
Fluticasone propionate with spacer
Arm Type
Experimental
Arm Description
Fluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Other Intervention Name(s)
Flixotide 125 mcg Evohaler
Intervention Description
Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days
Primary Outcome Measure Information:
Title
Incidence of adverse outcomes
Description
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
Secondary Outcome Measure Information:
Title
Duration of isolation based on WHO's criteria
Description
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
Title
The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94%
Description
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
Title
Self-reported recovery rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tran Thien Quan Vu, Dr
Phone
+0084934041123
Email
thienquan@ump.edu.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thi Tuyet Lan Le, Ph.D., M.D.
Organizational Affiliation
tuyetlanyds@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Pharmacy at Ho Chi Minh City
City
Ho Chi Minh City
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huynh Thi Cam Hong Le
Email
camhong3011@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
From Oct 2021 to September 2022.
IPD Sharing Access Criteria
Researchers who proposed use of data has been approved by a review committee.

Learn more about this trial

FLuticasone in cOvid Treatment (FLOT)

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