Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- COP Assessment Test Scale (CAT)
研究概览
简要总结
Recently, a new clinical presentation called "long covid" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to evaluate the efficacy of Montelukast in improving the quality of life associated with respiratory symptoms in patients with persistent COVID-19 symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.
详细描述
In December 2019, the first case of a new coronavirus causing pneumonia was described in Wuhan (China), designated as SARS-CoV-2 by the World Health Organization.
From the start of the SARS-CoV-2 alert until May 21st, 2020, 250,287 cases of coronavirus disease (COVID-19) were reported in Spain. The importance of the COVID-19 pandemic with its high humanitarian and economic cost, urgently requires effective therapies to reduce the severity, complications and mortality associated with this infection.
As the number of cases of COVID-19 increases, so does information regarding the management and evolution of the disease. More recently, a new clinical presentation called "long COVID-19" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations.
The inflammatory process produced at the pulmonary and extra pulmonary level, and the immune response triggered have been identified as important mechanisms in the pathophysiology of COVID-19.
Coronavirus infection activates the cytokine cascade at the immune level, in which leukotriene are possibly involved in the development of respiratory symptoms in patients with persistent symptoms after infection by SARS-CoV-2.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator and Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 80 years old with SARS-CoV-2 infection (positive CRP <10 days from the onset of symptoms) treated in Primary Health Care.
- •Persistent respiratory symptoms (more than 1 and <12 months of evolution)
- •Mild-moderate dyspnea: score at the beginning of the study 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 assigned medication during the 4 weeks.
- •Sign the informed consent
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-
- •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 any dose of systemic corticosteroids ≤ 30 days prior to inclusion
- •Use of gemfibrocil.
- •Hypersensitivity to montelukast or to any of the excipients included (e.g. lactose.
- •Any condition (including the inability to swallow pills) that, in the opinion of the researcher, would prevent the completion of taking the medication.
- •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, planning to get pregnant or patients of childbearing age not undergoing birth control methods.
- •Breastfeeding mother.
- •Any other condition for which, in the opinion of the principal investigator, it is considered that the subject does not fit the study.
研究组 & 干预措施
Placebo
oral placebo once daily for 28 days.
干预措施: placebo (Other)
Montelukast
10mg oral montelukast once daily for 28 days.
干预措施: Montelukast (Drug)
结局指标
主要结局
COP Assessment Test Scale (CAT)
时间窗: 7, 14, 21 and 28 days
Quality of life of respiratory symptoms according to COPD Assessment Test (CAT The COPD Assessment Test (CAT) is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.Quality of life of respiratory symptoms according to COPD Assessment Test (CAT). This is a validated self-administered scale to quantify and monitor the impact of COPD on well-being and daily life. It consists of 8 items (from 0 to 5 points), and a total score of 0-40 (0-9 mild, 10-20 moderate, 21-30 severe and 31-40 very severe), being higher scores worse outcome. A difference of 2 or more points in health status is considered clinically significant.
次要结局
- 1min sit-to-stand test(14 and 28 days)
- O2 desaturation(14 and 28 days)
- Number of visits to primary care(28 days)
- Number of visits to the emergency room(28 days)
- Number of hospital admissions.(28 days)
- Visual Analogical Scale (VAS)(7, 14, 21 and 28 days)
- Days of sick leave(28 days)
- All-cause mortality(7, 14, 21 and 28 days)
- Medication side effects(7, 14, 21 and 28 days)
- Factors of inflamatory and prothrombotic processes: D-Dimer, N-terminal prohormone of brain natriuretic peptide (NT Pro-BNP), C-reactive protenin and Antinuclear antibodies (ANA)(0 and 28 days)