FLuticasone in cOvid Treatment (FLOT)
FLOT
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
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Sep 2021
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedStudy Start
First participant enrolled
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedSeptember 23, 2021
September 1, 2021
4 months
September 20, 2021
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Duration of isolation based on WHO's criteria
Day 28 after randomization
The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94%
Day 28 after randomization
Self-reported recovery rate
Day 28 after randomization
Study Arms (2)
Standard Care
NO INTERVENTIONParticipants will be monitored via video call twice a day without any specific drugs.
Fluticasone propionate with spacer
EXPERIMENTALFluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care
Interventions
Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thi Tuyet Lan Le, Ph.D., M.D.
tuyetlanyds@gmail.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 23, 2021
Study Start
September 22, 2021
Primary Completion
January 31, 2022
Study Completion
August 30, 2022
Last Updated
September 23, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- From Oct 2021 to September 2022.
- Access Criteria
- Researchers who proposed use of data has been approved by a review committee.
Individual participant data collected during the trial, after deidentification.