Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19
Status:
Not yet recruiting
Trial end date:
2022-01-30
Target enrollment:
Participant gender:
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.