Covid19
Conditions
Keywords
SARS-CoV-2, corticosteroids, Bronchodilators
Brief summary
Introduction: SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), the new coronavirus, causes a disease called COVID-19 that can trigger aggressive inflammatory responses. In this sense, inhaled corticosteroid therapy (IC) has shown some favorable results in controlling the worsening of the disease, given that it has effects on pulmonary inflammation and can be an intervention to be used in the mild manifestations of COVID-19 in order to prevent disease progression and severity. Regarding the role of bronchodilators, studies have suggested that their combination with IC exerts synergistic therapeutic effects. Objective: To determine the efficacy of inhaled therapy of beclomethasone/formoterol/glycopyrronium (BFG) (100/6/12.5mcg) and/or beclomethasone HFA 250 mcg in preventing the use of healthcare resources in patients ≥ 18 years of age at 28 days compared to usual care. Method: participants will be randomized according to a ratio of 1:1:1 into three groups: (Group 1) Standard of care + BFG two doses 2x/day; (Group 2) standard treatment + beclomethasone HFA two doses 2x/day and (Group 3) standard treatment. After collecting the signed informed consent form, research participants will be treated for 28 days and, after two days, will undergo a spirometry test. Therefore, the total duration of the study for a given participant will be up to 30 days.
Interventions
DRUGinhaled beclametasone
Adding belcamethasone to standard of care for Covid 19 positive patients
DRUGInahaled beclomethasone / formoterol / glycopyrronium
Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients
Sponsors
Chiesi Farmaceutici S.p.A.
UPECLIN HC FM Botucatu Unesp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A research participant will be eligible to participate in this study if ALL of the following criteria are met: 1. Adult men or women (≥ 18 years of age) 2. PCR positive SarsCoV-2 3. Symptomatic participants must have at least 1 of the following symptoms in the inclusion: fever or self-reported fever perception in the last 24 hours, headache, sore throat, dry cough, fatigue, chest pain or choking sensation (without associating to respiratory distress), myalgia, anosmia, ageusia or gastrointestinal symptoms with up to 10 days onset. 4. Participants with arterial pulse oximetry (SpO2) saturation ≥ 92% in room air at inclusion. 5. Participants with the following hematological and biochemical laboratory parameters obtained in the period of 7 days before D0: * Hemoglobin\> 9.0 g / dL-1 * Absolute Neutrophil Count ≥ 1000 mm-³ * Platelets ≥ 100,000 mm-3 * Creatinine clearance ≥ 30 mL / min-1 using the Cockcroft-Gault formula * Alkaline phosphatase \<10 × upper limit of normal (LSN), AST (TGOS) and ALT (TGPS) \<10 × LSN. * Laboratory pregnancy test (Negative β-hCG). 6. Participants must understand, sign and date the voluntary informed consent form in writing at the visit prior to any specific protocol procedure. 7. Participants must be able and willing to comply with study visits and procedures, as per the protocol.
Exclusion criteria
Research participants who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in preventing the use of health resources in patients | 28 days after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway obstruction | 28 days after treatment | Spirometry |
| Small airway obstruction | 28 days after treatment | computadorized tomography |
Countries
Brazil
Outcome results
None listed