Overview

FLuticasone in cOvid Treatment (FLOT)

Status:
Recruiting
Trial end date:
2022-08-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Treatments:
Fluticasone
Xhance
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