NCT05054322

FLuticasone in cOvid Treatment (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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate	Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days

Timeline

• Start date: 2021-09-22
• Primary completion: 2022-01-31
• Completion: 2022-08-30
• First posted: 2021-09-23
• Last updated: 2021-09-23

Locations

1 site across 1 country: Vietnam