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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2021-000605-24
    Trial protocol
    		 ES  
    Global end of trial date
    28 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Sep 2024
    First version publication date
    19 Sep 2024
    Other versions
    Summary report(s)
    		 E-SPERANZA COVID Final report_ICH E3

    Trial information

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    Trial identification
    Sponsor protocol code
    ESPERANZA_COVID
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04695704
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IDIAP Jordi Gol
    Sponsor organisation address
    Gran Via de les Corts 587, Barcelona, Spain, 08007
    Public contact
    Unitat d'Estudi del Medicament (UEM), IDIAP Jordi Gol, 34 934824124, rmonfa@idiapjgol.info
    Scientific contact
    Unitat d'Estudi del Medicament (UEM), IDIAP Jordi Gol, 34 638686961, rmonfa@idiapjgol.info
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate the efficacy of montelukast versus placebo to improve the quality of life associated with respiratory symptoms at day 28.
    Protection of trial subjects
    Not applicable. Low risk intervention trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 86
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    85
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients 18 to 80 years old with SARS-CoV-2 infectiontreated in Primary Health Care, with persistent respiratory symptoms (more than 1 and <12 months of evolution) and mild-moderate dyspnea: score at the beginning of the study according to the modified Medical Research Council (mMRC) scale from 0 to 3.

    Pre-assignment period milestones
    Number of subjects started
    		 86
    Number of subjects completed
    		 86

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Unblinding process done when final results were available.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Montelukast
    Arm description
    		 10 mg oral montelukast once daily for 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pluralais
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg oral montelukast once daily for 28 days

    Arm title
    		 Placebo
    Arm description
    		 10 mg oral placebo once daily for 28 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg oral montelukast once daily for 28 days

    Number of subjects in period 1
    		Montelukast Placebo
    Started
    43
    43
    Completed
    38
    37
    Not completed
    5
    6
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    3
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Montelukast
    Reporting group description
    		 10 mg oral montelukast once daily for 28 days

    Reporting group title
    Placebo
    Reporting group description
    		 10 mg oral placebo once daily for 28 days

    Reporting group values
    		 Montelukast Placebo Total
    Number of subjects
    		 43 43 86
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 43 42 85
        From 65-84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 45.00 (38.50 to 49.00) 51.00 (41.50 to 56.50) -
    Gender categorical
    Units: Subjects
        Female
    		 36 32 68
        Male
    		 7 11 18

    End points

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    End points reporting groups
    Reporting group title
    Montelukast
    Reporting group description
    		 10 mg oral montelukast once daily for 28 days

    Reporting group title
    Placebo
    Reporting group description
    		 10 mg oral placebo once daily for 28 days

    Subject analysis set title
    Study completed population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Wilcoxon test was used for the comparison of quantitative variables and the chisquare test for the comparison of qualitative variables (or the Fisher test in case of extreme distributions in the crossed tables). In all comparisons, the statistical significance was set at 5%. Outcome measures were described and compared between the montelukast and placebo groups using the same statistics.

    Primary: Primary

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    End point title
    		 Primary
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 Montelukast Placebo Study completed population
    Number of subjects analysed
    43
    43
    86
    Units: [0-40]
        median (inter-quartile range (Q1-Q3))
    17.00 (11.50 to 19.50)
    12.00 (8.00 to 16.50)
    13.00 (8.00 to 18.00)
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Montelukast v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for reporting adverse events: Day 7, Day 14, Day 21, Day 28 and Day 56
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Montelukast
    Reporting group description
    		 10 mg oral montelukast once daily for 28 days

    Reporting group title
    Placebo
    Reporting group description
    		 10 mg oral placebo once daily for 28 days

    Serious adverse events
    		 Montelukast Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Montelukast Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 43 (18.60%)
    7 / 43 (16.28%)
    Nervous system disorders
    Insomnia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    Abdominal pain
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2021
    Adaptation of the protocol to the current long-covid profile patients associated with respiratory symptoms. Exclusion criteria related to a maximum of 3 months with symptomatology was extended until 12 months.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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