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

4R21/006

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.

2021-08-11

2023-07-24

2023-08-28

Terminated

Early phase I

86

Inclusion Criteria: * 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 Exclusion Criteria: * 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 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.

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2024-07-03