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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervation | No Intervention | patients receiving standart of care | |
| Experimental intervation one | Active Comparator | patients receiving standart of care + inhaled beclometasone |
|
| Experimental intervation two | Active Comparator | patients receiving standart of care + inhaled beclometasone/ formoterol / glycopyrronium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled beclametasone | Drug | Adding belcamethasone to standard of care for Covid 19 positive patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in preventing the use of health resources in patients | 28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Airway obstruction | Spirometry | 28 days after treatment |
| Small airway obstruction | computadorized tomography | 28 days after treatment |
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Inclusion Criteria: A research participant will be eligible to participate in this study if ALL of the following criteria are met:
Adult men or women (≥ 18 years of age)
PCR positive SarsCoV-2
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.
Participants with arterial pulse oximetry (SpO2) saturation ≥ 92% in room air at inclusion.
Participants with the following hematological and biochemical laboratory parameters obtained in the period of 7 days before D0:
Participants must understand, sign and date the voluntary informed consent form in writing at the visit prior to any specific protocol procedure.
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 exclusion criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas da Faculdade de Medicina de Botucatu | Botucatu | São Paulo | 18618687 | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Inahaled beclomethasone / formoterol / glycopyrronium | Drug | Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |