Status:
TERMINATED
Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:
Lead Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborating Sponsors:
Institut Català de la Salut
Conditions:
Covid19
SARS (Disease)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 dy...
Detailed Description
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 ale...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04695704
Start Date
August 11 2021
End Date
August 28 2023
Last Update
July 3 2024
Active Locations (8)
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1
Primaty health Center Corbera
Corbera de Llobregat, Barcelona, Spain, 08757
2
Primary Health Center Jaume Soler
Cornellà de Llobregat, Barcelona, Spain, 08940
3
Primary Health Center 17 Setember
el Prat de Llobregat, Barcelona, Spain, 08820
4
Primary Health Center Camps Blancs
Sant Boi de Llobregat, Barcelona, Spain, 08830