Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT04695704
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04695704
Study Brief:
Protocol Section:
NCT04695704