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
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EudraCT number |
2021-000605-24 |
Trial protocol |
ES |
Global end of trial date |
28 Aug 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Sep 2024
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First version publication date |
19 Sep 2024
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Other versions |
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Summary report(s) |
E-SPERANZA COVID Final report_ICH E3 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ESPERANZA_COVID
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04695704 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
IDIAP Jordi Gol
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Sponsor organisation address |
Gran Via de les Corts 587, Barcelona, Spain, 08007
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Public contact |
Unitat d'Estudi del Medicament (UEM), IDIAP Jordi Gol, 34 934824124, rmonfa@idiapjgol.info
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Scientific contact |
Unitat d'Estudi del Medicament (UEM), IDIAP Jordi Gol, 34 638686961, rmonfa@idiapjgol.info
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Jul 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Jul 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Aug 2023
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Was the trial ended prematurely? |
Yes
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General information about the trial
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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.
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Protection of trial subjects |
Not applicable. Low risk intervention trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 86
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Worldwide total number of subjects |
86
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EEA total number of subjects |
86
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
85
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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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
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Number of subjects started |
86 | ||||||||||||||||||
Number of subjects completed |
86 | ||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | ||||||||||||||||||
Blinding implementation details |
Unblinding process done when final results were available.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Montelukast | ||||||||||||||||||
Arm description |
10 mg oral montelukast once daily for 28 days | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
Pluralais
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg oral montelukast once daily for 28 days
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
10 mg oral placebo once daily for 28 days | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg oral montelukast once daily for 28 days
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Baseline characteristics reporting groups
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Reporting group title |
Montelukast
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Reporting group description |
10 mg oral montelukast once daily for 28 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
10 mg oral placebo once daily for 28 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Montelukast
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Reporting group description |
10 mg oral montelukast once daily for 28 days | ||
Reporting group title |
Placebo
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Reporting group description |
10 mg oral placebo once daily for 28 days | ||
Subject analysis set title |
Study completed population
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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.
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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.
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End point type |
Primary
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End point timeframe |
Day 28
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Statistical analysis title |
Primary endpoint | ||||||||||||||||
Comparison groups |
Montelukast v Placebo
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Number of subjects included in analysis |
86
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.02 | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Timeframe for reporting adverse events: Day 7, Day 14, Day 21, Day 28 and Day 56
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
Montelukast
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Reporting group description |
10 mg oral montelukast once daily for 28 days | |||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
10 mg oral placebo once daily for 28 days | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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.
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |