| Study name |
FLuticasone in cOvid Treatment (FLOT) |
| Methods |
Trial design: open‐label, RCT
Sample size: 500
Setting: outpatient
Language: English
Number of centres: not reported
Type of intervention: treatment |
| Participants |
Inclusion criteria:
signing consent to participate in the study having COVID‐19‐related symptoms within 5 days prior to randomisation confirmed diagnosis of COVID‐19 by rapid antigen test or PCR test within 5 days prior to randomisation aged > 50 years old or 18–49 years and have ≥ 1 risk factors for severe COVID‐19
Exclusion criteria:
pregnant or breastfeeding women allergy or contraindications (or both) to inhaled fluticasone current or previous administration of inhaled corticosteroids within the 15 days prior to randomisation current or previous administration of high‐dose systemic corticosteroids (> 3.75 mg dexamethasone/day or equivalent doses of other corticosteroids) or anticoagulants etc. ≥ 2 days within 15 days prior randomisation, or taking any other antiviral drugs (such as remdesivir, favipiravir, etc.) indication for start of systemic corticosteroids or oxygen therapy or hospitalisation due to COVID‐19 within next 24 hours already participated in other interventional COVID‐19 studies 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
|
| Interventions |
Intervention group: inhaled fluticasone 125 μg with spacer, 4 puffs, twice a day + standard care
Control group: standard care
Concomitant therapy: no |
| Outcomes |
Primary outcome: incidence of adverse outcomes day 28 after randomisation
Secondary outcomes: duration of isolation based on WHO's criteria day 28 after randomisation; incidence of patients with oxygen saturation by pulse oximetry (oxygen saturation) < 94% day 28 after randomisation; self‐reported recovery rate day 28 after randomisation |
| Starting date |
22 September 2021 |
| Contact information |
Thi Tuyet Lan Le, PhD, MD; tuyetlanyds@gmail.com |
| Notes |
Recruitment status: recruiting
Prospective completion date: 31 January 2022
Date last update was posted: 23 September 2021
Sponsor/funding: University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam |
