Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19

NCT04937543 | Completed Phase 2 DMC

• 1 other identifier: TRIV001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

SARS-CoV-2; corticosteroids; Bronchodilators

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in preventing the use of health resources in patients

  28 days after treatment

Secondary Outcomes (2)

• Airway obstruction

  28 days after treatment

• Small airway obstruction

  28 days after treatment

Study Arms (3)

No intervation

NO INTERVENTION

patients receiving standart of care

Experimental intervation one

ACTIVE COMPARATOR

patients receiving standart of care + inhaled beclometasone

Drug: inhaled beclametasone

Experimental intervation two

ACTIVE COMPARATOR

patients receiving standart of care + inhaled beclometasone/ formoterol / glycopyrronium

Drug: Inahaled beclomethasone / formoterol / glycopyrronium

Interventions

inhaled beclametasone DRUG

Adding belcamethasone to standard of care for Covid 19 positive patients

Experimental intervation one

Inahaled beclomethasone / formoterol / glycopyrronium DRUG

Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients

Experimental intervation two

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men or women (≥ 18 years of age)
• PCR positive SarsCoV-2
• 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).
• 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.

You may not qualify if:

• 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).
• Participants with pre-existing, severe and uncontrolled organ failure, which prevents participation in the study by the investigator's judgment (non-relevant cardiac disease)
• Participant diagnosed with previous asthma using inhaled or oral corticosteroids in the last four weeks.
• Participant with previous use, in the last ten days of randomization, of inhaled, oral or injectable corticosteroids.
• Participant with previous diagnosis of chronic obstructive pulmonary disease, even if he is not using any inhaled medication.
• Pregnant or lactating women.
• Use of any product under investigation or unregistered within 3 months or within 5 half-lives before baseline, whichever is longer.
• Hypersensitivity to the drug and / or its excipients.
• Any condition that, in the investigator's opinion, could compromise the participant's safety or his adherence to the study protocol.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18618687, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Formoterol Fumarate; Glycopyrrolate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 24, 2021
• Study Start: June 28, 2021
• Primary Completion: October 30, 2021
• Study Completion: May 20, 2022
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

BR (1)