FLuticasone in cOvid Treatment (FLOT)

University of Medicine and Pharmacy at Ho Chi Minh City

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Covid19

Treatments: Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Other

Identifiers

NCT05054322

466/HDDD-DYHD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Standard Care

No Intervention group

Description:

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

Fluticasone propionate with spacer

Experimental group

Description:

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

Treatment:

Drug: Fluticasone Propionate