Covid19Phase 2TRIVIDNCT04937543
Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19
A Phase 2 study testing inhaled beclametasone and Inahaled beclomethasone / formoterol / glycopyrronium in people with Covid19, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- inhaled beclametasone and Inahaled beclomethasone / formoterol / glycopyrronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jun 2021to 20 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Research participants who meet any of the following exclusion criteria will be excluded from the study:
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, 18618687
About this study
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)
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
- Being tested
- inhaled beclametasone, Inahaled beclomethasone / formoterol / glycopyrronium
- Keywords
- SARS-CoV-2, corticosteroids, Bronchodilators
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled beclametasoneDrug
Adding belcamethasone to standard of care for Covid 19 positive patients
Inahaled beclomethasone / formoterol / glycopyrroniumDrug
Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients
| Study group | Role | What they receive |
|---|---|---|
| No intervation | No intervention | patients receiving standart of care |
| Experimental intervation one | Active comparator | patients receiving standart of care + inhaled beclometasone Receives: Drug: inhaled beclametasone |
| Experimental intervation two | Active comparator | patients receiving standart of care + inhaled beclometasone/ formoterol / glycopyrronium Receives: Drug: Inahaled beclomethasone / formoterol / glycopyrronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in preventing the use of health resources in patients
Measured: 28 days after treatment
Secondary outcomes (2)
Airway obstruction
Spirometry
Measured: 28 days after treatment
Small airway obstruction
computadorized tomography
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start28 Jun 2021
- Primary completion30 Oct 2021
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937543
- Sponsor's protocol ID
- TRIV001
- Acronym
- TRIVID
- Status last verified
- Mar 2025
- First submitted
- 23 Jun 2021
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04937543
- Acronym / sponsor ID
- TRIVID / TRIV001
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, corticosteroids, Bronchodilators
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervation | No intervention | –patients receiving standart of care |
| Experimental intervation one | Active comparator | Drug: inhaled beclametasonepatients receiving standart of care + inhaled beclometasone |
| Experimental intervation two | Active comparator | Drug: Inahaled beclomethasone / formoterol / glycopyrroniumpatients receiving standart of care + inhaled beclometasone/ formoterol / glycopyrronium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Research participants who meet any of the following exclusion criteria will be excluded from the study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled beclametasoneAdding belcamethasone to standard of care for Covid 19 positive patients | Drug | Experimental intervation one |
| Inahaled beclomethasone / formoterol / glycopyrroniumAdding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients | Drug | Experimental intervation two |
Primary outcome
Proportion of patients in preventing the use of health resources in patients
Time frame: 28 days after treatment
2 secondary outcomes
Airway obstruction
Time frame: 28 days after treatment
Small airway obstruction
Time frame: 28 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled beclametasone and Inahaled beclomethasone / formoterol / glycopyrronium in people with Covid19, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in preventing the use of health resources in patients (time frame: 28 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.