Study to assess the efficacy of montelukast in improving respiratory symptoms in patients with long COVID: E-SPERANZA COVID PROJECT

Phase 1

• Conditions: Patients with a history of SAR-Cov-2 infection (PCR positive) with long Covid-19 and mild or moderate respiratory symptoms of more than 1 month and less than 4 months of evolution, attended in Primary Care.; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000605-24-ES
• Lead Sponsor: IDIAP Jordi Gol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-09
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

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

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified