Introduction: SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), the newcoronavirus, causes a disease called COVID-19 that can trigger aggressive inflammatoryresponses. In this sense, inhaled corticosteroid therapy (IC) has shown some favorableresults in controlling the worsening of the disease, given that it has effects onpulmonary inflammation and can be an intervention to be used in the mild manifestationsof COVID-19 in order to prevent disease progression and severity. Regarding the role ofbronchodilators, studies have suggested that their combination with IC exerts synergistictherapeutic effects. Objective: To determine the efficacy of inhaled therapy ofbeclomethasone/formoterol/glycopyrronium (BFG) (100/6/12.5mcg) and/or beclomethasone HFA250 mcg in preventing the use of healthcare resources in patients ≥ 18 years of age at 28days compared to usual care. Method: participants will be randomized according to a ratioof 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) standardtreatment. After collecting the signed informed consent form, research participants willbe 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.
Not Provided
Drug: inhaled beclametasone
Adding belcamethasone to standard of care for Covid 19 positive patients
Drug: Inahaled beclomethasone / formoterol / glycopyrronium
Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19
positive patients
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 exclusion criteria will be excluded
from the study:
1. Participants with moderate or severe acute respiratory failure or needing
non-invasive ventilation or oxygen, or with SpO2 <92% or tachypnea (respiratory rate
≥ 30 breaths / minute).
2. Participants with pre-existing, severe and uncontrolled organ failure, which
prevents participation in the study by the investigator's judgment (non-relevant
cardiac disease)
3. Participant diagnosed with previous asthma using inhaled or oral corticosteroids in
the last four weeks.
4. Participant with previous use, in the last ten days of randomization, of inhaled,
oral or injectable corticosteroids.
5. Participant with previous diagnosis of chronic obstructive pulmonary disease, even
if he is not using any inhaled medication.
6. Pregnant or lactating women.
7. Use of any product under investigation or unregistered within 3 months or within 5
half-lives before baseline, whichever is longer.
8. Hypersensitivity to the drug and / or its excipients.
9. Any condition that, in the investigator's opinion, could compromise the
participant's safety or his adherence to the study protocol.
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Not Provided