FLuticasone in cOvid Treatment (FLOT)

Launched by UNIVERSITY OF MEDICINE AND PHARMACY AT HO CHI MINH CITY · Sep 21, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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