Clinical trial NCT05054322: FLuticasone in cOvid Treatment (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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: COVID19
Fluticasone Propionate
inhaled corticosteroid
ICS
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse outcomes
timeFrame: Day 28 after randomization
Secondary outcomes:
measure: Duration of isolation based on WHO's criteria
timeFrame: Day 28 after randomization
measure: The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94%
timeFrame: Day 28 after randomization
measure: Self-reported recovery rate
timeFrame: Day 28 after randomization
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
affiliation: tuyetlanyds@gmail.com
name: Thi Tuyet Lan Le, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: