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
|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: 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|
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 ]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.
- 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.
- 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.
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, MDfirstname.lastname@example.org|
|Contact: Rosa Morros Padro, PhDemail@example.com|
|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|