Ciclesonide Clinical Trial for COVID-19 Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 215
- 试验地点
- 3
- 主要终点
- Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
研究概览
简要总结
The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19 patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used and is readily available. It has a low rate of side effects and few interactions with other drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect. Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in individuals who are not admitted to hospital at time of diagnosis of COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Symptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with fever, cough, or shortness of breath. Provision of Informed Consent
- •At day 0, patients should be at home
排除标准
- •Already on inhaled corticosteroid medication
- •Currently using systemic steroids (oral or intravenous or intramuscular such as Prednisone) or use of steroids 7 days prior to enrolment
- •Severely ill patients at enrollment (i.e., admitted to ICU at admission)
- •Unable to self-administer the inhaler
- •Known or suspected pregnancy and breastfeeding
- •Known allergy to study medication or its components (non-medicinal ingredients; including lactose allergy (type I))
- •Patients with untreated fungal, bacterial, or tubercular infections of the respiratory tract
- •Current hospitalization
- •Current use of oxygen at home or in the hospital
研究组 & 干预措施
Ciclesonide inhaled and nasal
Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days
干预措施: Ciclesonide (Drug)
Ciclesonide inhaled and nasal
Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days
干预措施: Ciclesonide nasal (Drug)
Placebo
Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
干预措施: Normal Saline intranasal and placebo inhaler (Drug)
结局指标
主要结局
Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
时间窗: day 7
Proportion of participants with no symptoms of cough, fever or dyspnea at day 7
次要结局
- Mortality(day 29)
- Improvement in Dyspnea: Resolution of Dyspnea at Day 7(day 7)
- Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7(day 7)
- Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14(Day 14)
- Proportion of Participants Hospitalized for SARS-CoV-2(day 14)
- Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea(Day 14)
- Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7(Day 7)
研究者
Nicole Ezer, MD, FRCPC, MPH
Assistant Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre