Covid19Phase 2/3FLOTNCT05054322
FLuticasone in cOvid Treatment (FLOT)
A Phase 2/3 study testing Fluticasone Propionate in people with Covid19, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteVietnam
- Study dates
- 22 Sep 2021to 30 Aug 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City
Huynh Thi Cam Hong Le, camhong3011@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Fluticasone Propionate
- Keywords
- COVID19, Fluticasone Propionate, inhaled corticosteroid, ICS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Also called Flixotide 125 mcg Evohaler
Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28 after randomization
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Day 28 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start22 Sep 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vu Tran Thien Quan, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Thi Tuyet Lan Le, Ph.D., M.D., Principal investigator, tuyetlanyds@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054322
- Sponsor's protocol ID
- 466/HDDD-DYHD
- Acronym
- FLOT
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05054322
- Acronym / sponsor ID
- FLOT / 466/HDDD-DYHD
- Conditions
- Covid19
- Keywords
- COVID19, Fluticasone Propionate, inhaled corticosteroid, ICS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 22 Sep 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will be monitored via video call twice a day without any specific drugs. |
| Fluticasone propionate with spacer | Experimental | Drug: Fluticasone PropionateFluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone PropionateAlso: Flixotide 125 mcg EvohalerFluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days | Drug | Fluticasone propionate with spacer |
Primary outcome
Incidence of adverse outcomes
Time frame: 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.
3 secondary outcomes
Duration of isolation based on WHO's criteria
Time frame: Day 28 after randomization
The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94%
Time frame: Day 28 after randomization
Self-reported recovery rate
Time frame: Day 28 after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi Tuyet Lan Le, Ph.D., M.D. principal investigator
tuyetlanyds@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fluticasone Propionate in people with Covid19, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tran Thien Quan Vu, Dr (+0084934041123, thienquan@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse outcomes (time frame: Day 28 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.