Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04937543
Study type Interventional
Source UPECLIN HC FM Botucatu Unesp
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 28, 2021
Completion date May 20, 2022

See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3