FLuticasone in cOvid Treatment (FLOT)

Last updated: September 21, 2021
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Overall Status: Active - Recruiting

Phase

2/3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05054322
466/HDDD-DYHD
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 severeCOVID-19

Exclusion

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 priorto 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/oranticoagulants 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 hospitalizationdut 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 notparticipate for the benefit of the patient or that would prevent, limit, or distortthe evaluation of the study procedure

Study Design

Total Participants: 500
Study Start date:
September 22, 2021
Estimated Completion Date:
August 30, 2022

Study 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.

Connect with a study center

  • University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

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