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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of adverse outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing consent to participate in the study
- •Having COVID related-symptoms within 5 days prior to randomization
- •Confirmed diagnosis of COVID-19 by rapid antigen test or polymerase chain reaction (PCR) test within 5 days prior to randomization
- •Over 50 years old OR 18-49 years old and have one or more of risk factors for severe COVID-19
排除标准
- •Pregnant or breastfeeding woman
- •Allergy and/or contraindications to inhaled Fluticasone
- •Current or previous administration of inhaled corticosteroids within the 15 days prior to randomization
- •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..)
- •Indication for start of systemic corticosteroids or oxygen therapy or hospitalization dut to COVID-19 within next 24 hours
- •Already participated in other interventional COVID 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
研究组 & 干预措施
Fluticasone propionate with spacer
Fluticasone propionate 125 mcg with spacer, 4 puffs, twice a day, added to standard care
干预措施: Fluticasone Propionate (Drug)
结局指标
主要结局
Incidence of adverse outcomes
时间窗: Day 28 after randomization
To evaluate the efficacy of fluticasone propionate MDI added to standard care at an early stage COVID-19 in reducing the incidence of adverse outcomes (oxygen therapy, systemic corticosteroids, hospitalization, mechanical ventilation, and mortality) in symptomatic patients either from 18 to 49-year-old with risk factors or older than 50-year-old.
次要结局
- Duration of isolation based on WHO's criteria(Day 28 after randomization)
- The incidence of patients with oxygen saturation by pulse oximetry (SpO2) <94%(Day 28 after randomization)
- Self-reported recovery rate(Day 28 after randomization)
研究者
Vu Tran Thien Quan
Lecturer
University of Medicine and Pharmacy at Ho Chi Minh City