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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04937543
Recruitment Status : Active, not recruiting
First Posted : June 24, 2021
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
UPECLIN HC FM Botucatu Unesp

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: inhaled beclametasone Drug: Inahaled beclomethasone / formoterol / glycopyrronium Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Three Arms Study to Evaluate the Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19 and in the Prevention of the Use of Health Resources in Patients With ≥ 18 Years Old (TRIVID Study)
Actual Study Start Date : June 28, 2021
Actual Primary Completion Date : October 30, 2021
Estimated Study Completion Date : May 20, 2022


Arm Intervention/treatment
No Intervention: No intervation
patients receiving standart of care
Active Comparator: Experimental intervation one
patients receiving standart of care + inhaled beclometasone
Drug: inhaled beclametasone
Adding belcamethasone to standard of care for Covid 19 positive patients

Active Comparator: Experimental intervation two
patients receiving standart of care + inhaled beclometasone/ formoterol / glycopyrronium
Drug: Inahaled beclomethasone / formoterol / glycopyrronium
Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients




Primary Outcome Measures :
  1. Proportion of patients in preventing the use of health resources in patients [ Time Frame: 28 days after treatment ]

Secondary Outcome Measures :
  1. Airway obstruction [ Time Frame: 28 days after treatment ]
    Spirometry

  2. Small airway obstruction [ Time Frame: 28 days after treatment ]
    computadorized tomography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937543


Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil, 18618687
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Chiesi Farmaceutici S.p.A.
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Responsible Party: UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT04937543    
Other Study ID Numbers: TRIV001
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UPECLIN HC FM Botucatu Unesp:
SARS-CoV-2
corticosteroids
Bronchodilators
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Beclomethasone
Glycopyrrolate
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones