Novel coronavirus pneumonia (COVID-19) MedDRA version: 23.0 Level: LLT Classification code 10084383 Term: Novel COVID-19-infected pneumonia System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Montelucaste Generis
Pharmaceutical Form: Film-coated tablet
Sponsors
Instituto de Saúde Pública Universidade Porto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Admitted to a hospital with a diagnosis of moderate or severe COVID-19 pneumonia defined as: a. moderate cases: showing fever and respiratory symptoms with radiological findings of pneumonia; b. severe cases meeting any of the following criteria: i) respiratory distress (?30 breaths/ min); ii) oxygen saturation=93% at rest without oxygen inhalation; iii) PaO2/FiO2(fraction of inspired oxygen)=300mmHg; iv) with chest imaging that showed obvious lesion progression within 24-48 hours >50% shall be managed as severe cases 2. Subject, or legally authorized representative, provides written informed consent prior to the initiation of any study procedures. 3. Understands and agrees to comply with planned study procedures. 4. Agrees to the collection of oropharyngeal swabs. 5. Male or non-pregnant female adult > / = 18 years of age at the time of enrollment. 6. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen collected / = 72 hours since positive PCR, the PCR may be repeated to assess eligibility. 7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Admitted to a hospital with a diagnosis of critical type of COVID-19 pneumonia defined as any of the follow: i) requiring mechanical ventilation, ii) extracorporeal life support (ECMO, ECCO2R, RRT); iii) shock, iv) multiple organ dysfunction syndrome. Patients who are participating in another drug clinical trials. 2. Requiring dialysis. 3. Pregnancy or breast feeding. 4. Allergy to any study medication. 5. Severe basic diseases that affect survival, including uncontrolled malignant tumors that have metastasized and cannot be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.; 6. Pulmonary tumors caused by obstructive pneumonia, severe interstitial fibrosis, alveolar proteinosis, allergic alveolitis. 7. Continued use of immunosuppressive agents or organ transplants in the last 6 months. 8. Expected deaths within 48 hours. 9. Clinicians judge inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess efficacy and safety of Montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19);Secondary Objective: Not applicable;Primary end point(s): Improvement of COVID-19 disease status defined by the percentage of subjects reporting each severity rating on an 8-point ordinal scale [Time Frame: Day 29] The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. ;Timepoint(s) of evaluation of this end point: Time Frame: Day 1 through Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in alanine transaminase (ALT), aspartate transaminase (AST) [Time Frame: Day 1 through Day 29], creatinine, glucose, hemoglobin, platelets, prothrombin time (PT), total bilirubin, and white blood cell count with differential [Time Frame: Day 1 through Day 29] 2. Change in National Early Warning Score (NEWS) from baseline [Time Frame: Day 1 through Day 29]. The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure, available at https://www.mdcalc.com/national-early-warning-score-news 3. Clinical status using an ordinal scale [Time Frame: Day 3 through Day 29] a. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. 4. Cumulative incidence of Grade 3 and 4 adverse events (AEs) [Time Frame: Day 1 through Day 29] a. Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. b. Grade 4 AEs are defined as events that are potentially life threatening. 5. Cumulative incidence | — |
Countries
Portugal
Contacts
Public ContactClinical trials information
Instituto de Saúde Pública Universidade Porto
Outcome results
None listed