EUCTR2021-000605-24-ES
进行中（未招募）
1 期
Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID: E-SPERANZA COVID PROJECT - Montelukast in Mild-moderate Respiratory Symptoms in Patients with Long-COVID
适应症Patients with a history of SAR-Cov-2 infection (PCR positive) with long Covid-19 and mild or moderate respiratory symptoms of more than 1 month and less than 4 months of evolution, attended in Primary Care.MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Patients with a history of SAR-Cov-2 infection (PCR positive) with long Covid-19 and mild or moderate respiratory symptoms of more than 1 month and less than 4 months of evolution, attended in Primary Care.
- 发起方
- IDIAP Jordi Gol
- 入组人数
- 284
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Patients aged 18 to 80 years with SARS\-CoV\-2 infection (positive PCR) attended in Primary Care.
- •Persistent respiratory symptoms (more than 1 and \<4 months of evolution)
- •Mild\-moderate dyspnea: score at baseline according to the modified Medical Research Council (mMRC) scale from 0 to 3
- •The patient must be competent to complement the follow\-up evaluations.
- •The patient agrees to participate in the study and take the assigned medication during the 4 weeks.
- •Sign the informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 200
排除标准
- •Severity criteria: fever\> 38ºC, or O2 saturation \<93%.
- •Patients with SARS\-Cov\-2 pneumonia in the acute / subacute phase.
- •Patients who have required hospital admission for SARS\-Cov\-2\.
- •Chronic Obstructive Pulmonary Disease (COPD), asthma, bronchiectasis, pulmonary fibrosis, obstructive sleep apnea syndrome (OSAS), chronic respiratory failure from any cause, home oxygen therapy.
- •Use of montelukast or zafirlukast \= 30 days prior to inclusion
- •Use of gemfibrocil.
- •Hypersensitivity to montelukast, lactose intolerance or intolerance to any of the excipients of the trial treatment.
- •Active malignancy, current or recent chemotherapy treatment (\<6 months).
- •Medical history of infection by the Human Immunodeficiency Virus (HIV) or any serious immunocompromised state.
- •Pregnancy or planning of being pregnant.
结局指标
主要结局
未指定
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