Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:

NCT04695704 | Terminated Phase 3 DMC

• 1 other identifier: 4R21/006
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Covid19; SARS (Disease)

Keywords

SARS-CoV-2; Montelukast; Leukotriene Antagonists; Primary Health Care; Clinical Trial; Quality of Life; Long Term Covid

Outcome Measures

Primary Outcomes (1)

• COP Assessment Test Scale (CAT)

  Quality of life of respiratory symptoms according to COPD Assessment Test (CAT The COPD Assessment Test (CAT) is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.Quality of life of respiratory symptoms according to COPD Assessment Test (CAT). This is a validated self-administered scale to quantify and monitor the impact of COPD on well-being and daily life. It consists of 8 items (from 0 to 5 points), and a total score of 0-40 (0-9 mild, 10-20 moderate, 21-30 severe and 31-40 very severe), being higher scores worse outcome. A difference of 2 or more points in health status is considered clinically significant.

  7, 14, 21 and 28 days

Secondary Outcomes (10)

• 1min sit-to-stand test

  14 and 28 days

• O2 desaturation

  14 and 28 days

• Visual Analogical Scale (VAS)

  7, 14, 21 and 28 days

• All-cause mortality

  7, 14, 21 and 28 days

• Number of visits to primary care

  28 days

Study Arms (2)

Montelukast

EXPERIMENTAL

10mg oral montelukast once daily for 28 days.

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

oral placebo once daily for 28 days.

Other: placebo

Interventions

Montelukast DRUG

10 mg oral montelukast once daily for 28 days

Also known as: antileukotriene

Montelukast

placebo OTHER

10 mg oral placebo once daily for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator

Study Sites (8)

Primaty health Center Corbera

Corbera de Llobregat, Barcelona, 08757, Spain

Location

Primary Health Center Jaume Soler

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

Primary Health Center 17 Setember

el Prat de Llobregat, Barcelona, 08820, Spain

Location

Primary Health Center Camps Blancs

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Primary Health Center Molí Nou

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Primary Health Center Vinyets

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Primary Health Center ElPla

Sant Feliu de Llobregat, Barcelona, 08980, Spain

Location

Primary Health Center Raval nord

Barcelona, 08001, Spain

Location

Related Publications (1)

• Mera-Cordero F, Bonet-Monne S, Almeda-Ortega J, Garcia-Sangenis A, Cunillera-Puertolas O, Contreras-Martos S, Alvarez-Munoz G, Monfa R, Balanzo-Joue M, Morros R, Salvador-Gonzalez B. Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol. Trials. 2022 Jan 6;23(1):19. doi: 10.1186/s13063-021-05951-w.

  PMID: 34991703 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Disease

Interventions

montelukast

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesus Almeda Ortega, PhD

  Institut Català de la Salut

  STUDY CHAIR

• Sara Bonet Monne, PhD

  Institut Català de la Salut

  STUDY CHAIR

• Betlem Salvador Gonzalez, PhD

  Institut Català de la Salut

  STUDY CHAIR

• Francisco Mera Cordero, MD

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator and Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized placebo-controlled clinical trial,.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 5, 2021
• Study Start: August 11, 2021
• Primary Completion: July 24, 2023
• Study Completion: August 28, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)