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

IDIAP Jordi Gol0 个研究点目标入组 284 人开始时间: 2021年7月9日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 84

•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.
•Breastfeeding mother.
•Any other condition for which, in the opinion of the principal investigator, it is considered that the subject will not be able to perform the clinical trial procedures.

发起方