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Montelukast Clinical Trial in Mild-moderate Respiratory Symptoms in Patients With Long-COVID (ESPERANZA COVID) (ESPERANZACOVID)

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ClinicalTrials.gov Identifier: NCT04695704
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
Institut Català de la Salut
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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.

Condition or disease Intervention/treatment Phase
Covid19 SARS (Disease) Drug: Montelukast Other: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind randomized placebo-controlled clinical trial,.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator and Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID: E-SPERANZA COVID PROJECT
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
Experimental: Montelukast
10mg oral montelukast once daily for 28 days.
Drug: Montelukast
10 mg oral montelukast once daily for 28 days
Other Name: antileukotriene

Placebo Comparator: Placebo
oral placebo once daily for 28 days.
Other: placebo
10 mg oral placebo once daily for 28 days




Primary Outcome Measures :
  1. COP Assessment Test Scale (CAT) [ Time Frame: 7, 14, 21 and 28 days ]
    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.


Secondary Outcome Measures :
  1. 1min sit-to-stand test [ Time Frame: 14 and 28 days ]
    Exercise capacity: number of repetitions performed in the 1min sit-to-stand test

  2. O2 desaturation [ Time Frame: 14 and 28 days ]
    O2 desaturation ≥ 4% with effort (1min sit-to-stand test)

  3. Visual Analogical Scale (VAS) [ Time Frame: 7, 14, 21 and 28 days ]
    Symptoms evaluated using numeric Visual Analogical Scale (VAS): asthenia, headache, ageusia, anosmia, and rhinitis.

  4. All-cause mortality [ Time Frame: 7, 14, 21 and 28 days ]
    Mortality from any cause during the study

  5. Number of visits to primary care [ Time Frame: 28 days ]
    Number of visits of any kind to primary health care settings (phone visit or face to face visit) during the study period.

  6. Number of visits to the emergency room [ Time Frame: 28 days ]
    Number of visits to emergency room form primary health o hospital settings during the study period.

  7. Number of hospital admissions. [ Time Frame: 28 days ]
    Number of hospital admissions during the study period.

  8. Medication side effects [ Time Frame: 7, 14, 21 and 28 days ]
    Number and type of adverse reactions during the study period related to medication.

  9. Days of sick leave [ Time Frame: 28 days ]
    Number of days of incapacity for work (sick leave) during the study period.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <3 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695704


Contacts
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Contact: Francisco M Mera Cordero, MD +34699942492 franmcor@hotmail.com
Contact: Rosa Morros Padro, PhD +34934824124 idiap@idiapjgol.org

Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Institut Català de la Salut
Investigators
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Study Chair: Jesus Almeda Ortega, PhD Foundation Jordi GOL
Study Chair: Sara Bonet Monne, PhD Institut Català de la Salut
Study Chair: Betlem Salvador Gonzalez, PhD Institut Català de la Salut
Principal Investigator: Francisco Mera Cordero, MD Institut Català de la Salut
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT04695704    
Other Study ID Numbers: PENDING
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
SARS-CoV-2
Montelukast
Leukotriene Antagonists
Primary Health Care
Clinical Trial
Quality of Life
Long Term Covid
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory
Montelukast
Leukotriene Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action