Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Emergency department attendance of hospitalisation related to COVID-19
研究概览
简要总结
At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus.
Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells.
Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible.
The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.
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
- •Participant is willing and able to give informed consent for participation in the trial
- •Male or Female, aged 18 years or above
- •New onset of symptoms suggestive of COVID-19 e.g. new onset cough and/or fever, and/or loss of smell or taste within 7 or fewer days of participant being seen at visit 1
- •In the Investigator's opinion, is able and willing to comply with all trial requirements
排除标准
- •A known allergy to investigational medicine product (IMP) (budesonide)
- •Any known contraindication to any of the IMPs (budesonide)
- •Patient currently prescribed inhaled or systemic corticosteroids
- •Recent use, within the previous 7 days of inhaled or systemic corticosteroids
- •Patient needs hospitalisation at time of study consent
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
研究组 & 干预措施
Inhaled budesonide
Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
干预措施: Budesonide dry powder inhaler (Drug)
结局指标
主要结局
Emergency department attendance of hospitalisation related to COVID-19
时间窗: Day 1 to day 28
Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19
次要结局
- Blood oxygen saturation level(Day 1 to day 14)
- Symptoms as assessed by common cold questionnaire(Day 1 to day 14)
- Symptoms as assessed by FluPro questionnaire(Day 1 to day 14)
- Body temperature(Day 1 to day 14)
- Nasal/throat swab SARS-CoV-2 viral load(Day 1, 7 and 14)