PACTR202006537901307招募中3 期
An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild/moderate cases of COVID-19
Drug for Neglected Diseases initiative0 个研究点目标入组 3,000 人开始时间: 2020年6月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients,
- •2.Adults > or= 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
- •3.COVID-19 confirmed by molecular biology or validated antigenic test available in the country for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening.
- •4.Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) > or= 94%.
- •5.Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
- •6.Signed written consent from the patient or his/her representative.
- •7.Accepting and having the ability to be reached by telephone throughout the study.
- •8.Having designated a contact person who can be contacted in case of emergency.
排除标准
- •1.Abnormal physical examination findings:
- •respiratory rate > or= 25 per minute;
- •blood pressure < 90/60 mmHg or > 160/100 mmHg;
- •body weight < 45 kg for patients > or= 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis;
- •recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L).
- •2Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
- •3.Feeling unwell for more than 7 days prior to screening.
- •4 to 7Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
- •8.End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
- •9.-13Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
- •14.On-going treatment at screening with:
- •chronic systemic glucocorticosteroid > 40 mg daily;
- •immunosuppressive treatment;
- •15.For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use.
- •16.Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber.
- •17.Any other reason that makes it impossible to monitor the patient during the study.
- •18.Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening.
- •19.Known pulmonary arterial hypertension (PAH) or fibrosis.
- •20.Use of concomitant medications that are contraindicated with ciclesonide, known hypersensitivity to ciclesonide or any other ingredient in the formulation.
- •21........
研究者
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