Enfermedad en pacientes vulnerables con COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Biresp Spiromax
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration nu
Sponsors
Fundació Eurecat
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients capable of understanding the terms of the trial and agreeing to participate on it. 2. Patients who sign the informed consent or oral consent with subsequent written confirmation. 3. Patients = 65 years of age or = 50 years with a documented diagnosis in the medical history of at least one of the following comorbidities: arterial hypertension (diagnosed in the medical history and under treatment with antihypertensive drugs, cardiovascular disease, obesity (BMI > 30), diabetes, COPD, or active cancer. 4. Positive antigen test for SARS-CoV-2. 5. Less than 10 days from the appearance of the first symptoms at the time of randomization 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. Current treatment with inhaled beta-adrenergic blockers (including eye drops), corticosteroids, or beta 2 -agonists for any indication. 2. Patients with contraindications for the use of budesonide / formoterol: hypersensitivity to the active substances or to the excipient included, lactose monohydrate, or in case of active pulmonary tuberculosis. 3. Patients with a previous history of cardiac arrhythmias (eg, atrial fibrillation, supraventricular tachycardia, and extrasystoles). 4. Patients who are participating in another clinical trial. 5. Pregnant or lactating women. 6. Women and men of childbearing potential who are unwilling to use an effective contraceptive method (such as oral contraceptives, intrauterine device, or barrier method of contraception along with spermicide or surgical sterilization), during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate the effect of the inhaled budesonide / formoterol combination (BiResp Spiromax®) on the evolution of patients at risk with COVID-19 compared to standard of care.;Secondary Objective: 1. Evaluate and compare the impact on the rate of hospital admissions 2. Evaluate and compare the mortality for the patients assigned to the two treatment groups. 3. Evaluate and compare the rate of admission to the ICU for the patients assigned to the two treatment groups. 4. Evaluate and compare the length of hospital stay for the patients assigned to the two treatment groups. 5. Evaluate and compare the safety profile for the patients assigned to the two treatment groups.;Primary end point(s): Change in the Dublin-Boston score [1] in the 2 treatment groups from the start of treatment (D0) to day 4 (D + 4). A significant clinical response in terms of the Dublin-Boston score will be considered a decline on the scale of at least one category. The percentage of patients included in categories -1 and -2 to D + 4 will be compared;Timepoint(s) of evaluation of this end point: From the start of treatment (D0) to day 4 (D+4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients requiring admission to the hospital ward for COVID-19 after 30 days from the start of treatment. • Mortality from COVID-19 at +30 days. Death or death from COVID is defined when it is caused by respiratory failure, acute respiratory distress syndrome, multiorgan failure or any other serious complication, during the course of the evolution of an acute infection by SARS-CoV-2. • Frequency of comorbidities. • Percentage of patients requiring admission to the ICU. • Days of length of hospital stay • The variables to be measured will be the frequency of adverse events, the frequency of serious adverse effects, the frequency of adverse effects that lead to the interruption of treatment, the number of deaths and the frequency of laboratory changes not directly related to COVID disease. -19.;Timepoint(s) of evaluation of this end point: D0, D+4, D+7, D+14, D+30 (End of Treatment Visit/ Early withdrawal) | — |
Countries
Spain
Contacts
Public ContactClinical Trials Department
Dynamic Science S.L.
Outcome results
None listed