Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: (E-SPERANZA)
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|ClinicalTrials.gov Identifier: NCT04695704|
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : March 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS (Disease)||Drug: Montelukast Other: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|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)|
|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-19: E-SPERANZA COVID-19 PROJECT|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
10mg oral montelukast once daily for 28 days.
10 mg oral montelukast once daily for 28 days
Other Name: antileukotriene
Placebo Comparator: Placebo
oral placebo once daily for 28 days.
10 mg oral placebo once daily for 28 days
- COP Assessment Test Scale (CAT) [ Time Frame: 7, 14, 21 and 28 days ]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.
- 1min sit-to-stand test [ Time Frame: 14 and 28 days ]Exercise capacity: number of repetitions performed in the 1min sit-to-stand test
- O2 desaturation [ Time Frame: 14 and 28 days ]O2 desaturation ≥ 4% with effort (1min sit-to-stand test)
- 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 . It is numbered from 0-10, where 0 is the absence and 10 the greatest intensity, meaning higher scores worse outcome. The patient selects the number that best evaluates the intensity of the symptom.
- All-cause mortality [ Time Frame: 7, 14, 21 and 28 days ]Mortality from any cause during the study
- 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.
- 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.
- Number of hospital admissions. [ Time Frame: 28 days ]Number of hospital admissions during the study period.
- Medication side effects [ Time Frame: 7, 14, 21 and 28 days ]Number and type of adverse reactions during the study period related to medication.
- Days of sick leave [ Time Frame: 28 days ]Number of days of incapacity for work (sick leave) during the study period.
- Factors of inflamatory and prothrombotic processes: D-Dimer, N-terminal prohormone of brain natriuretic peptide (NT Pro-BNP), C-reactive protenin and Antinuclear antibodies (ANA) [ Time Frame: 0 and 28 days ]To analyze wether the factors of inflamatory and prothrombotic processes (D-Dimer, Pro-BNP, C-reactive protein, and ANA) at the begining of the study are response predictors to the treatment.
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
|Contact: Francisco M Mera Cordero, MDemail@example.com|
|Contact: Rosa Morros Padro, PhDfirstname.lastname@example.org|
|Study Chair:||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|
|Principal Investigator:||Francisco Mera Cordero, MD||Institut Català de la Salut|