COVID-19Phase 2BREATHNCT05196581
Efficacy of Breathox Device Inhalation Therapy in the Treatment of Acute Symptoms Associated With COVID-19 and in the Prevention of the Use of Health Resources
A Phase 2 study testing Dispersible NaCl powder 10 sessions and Dispersible NaCl powder 5 sessions in people with COVID-19, run by Suzana Erico Tanni Minamoto at 1 site in Brazil.
Trial summary
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, in vitro intervention with high concentrations of sodium chloride has shown some favorable results in the inactivation of the disease… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Dispersible NaCl powder 10 sessions and Dispersible NaCl powder 5 sessions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2021to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males or females (≥ 18 years of age), not hospitalized, diagnosed with SARS-CoV-2 infection by oropharyngeal RT-PCR or swab antigen test, with mild symptoms of infection.
- Symptomatic subjects must have at least 1 of the following symptoms at inclusion: fever or fever perceived for more than 24 hours, headache, sore throat, nasal obstruction, dry cough, fatigue, chest pain, or choking sensation (no associated respiratory distress ), myalgia, anosmia, ageusia or gastrointestinal symptoms within 10 days of onset;
- Subjects with arterial pulse oximetry (SpO2) saturation ≥ 92% in room air at inclusion;
- Participants with the following hematological and biochemical laboratory parameters obtained within 7 days before D0:
- Hemoglobin > 9.0 g/dL-1
- Absolute Neutrophil Count ≥ 1000 mm-³
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- Platelets ≥ 100,000 mm-3
- Creatinine clearance ≥ 30 mL/min-1 by Cockcroft-Gault formula
- Rapid negative pregnancy test for women of childbearing age. and. Participants must understand, sign and date the voluntary written consent form at the visit prior to any protocol-specific procedure;
- Participants must be able and willing to comply with study visits and procedures as per protocol.
Who cannot join
- Moderate or severe acute respiratory failure, or requiring non-invasive ventilation or oxygen, or with SpO2 <92% or tachypnea (respiratory rate ≥30 breaths/minute);
- Serious and uncontrolled preexisting organ insufficiency, which prevents participation in the study by the investigator's judgment;
- Diagnosis of previous asthma using inhaled or oral corticosteroids in the last four weeks;
- Previous use, in the last ten days of randomization, of inhaled, oral or intravenous corticosteroids; hydroxychloroquine and dewormers.
- Previous diagnosis of chronic obstructive pulmonary disease, even when not using any inhaled medication;
- Pregnant or lactating women;
- Use of any investigational or unrecorded product within the 3 month period or the 5 half-lives period prior to the baseline period, whichever is longer;
- Any condition that, in the investigator's opinion, could compromise the participant's safety or 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 Study to Evaluate the Efficacy of Breathox Device Inhalation Therapy 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
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, in vitro intervention with high concentrations of sodium chloride has shown some favorable results in the inactivation of the disease Objective: to determine the effectiveness of inhaled sodium chloride therapy (BREATHOX®) in preventing the use of health resources in patients ≥ 18 years of age in 28 days compared to usual care. Method: Pilot, open randomized clinical trial study, including 100 patients with COVID-19 confirmed and symptomatic with up to 10 days of symptom onset. The included participants will be randomized according to a ratio of 1:1:1 into three groups: (Group 1) Standard of care + BREATHOX® one session (two oral inhalations and more nasal instillation in each nostril) every hour with a total of 10 sessions per day for 10 days; (Group 2) standard of care + BREATHOX® one session (two oral inhalations and more nasal instillation in each nostril) every three hours for a total of 5 sessions per day for 10 days; (Group 3) standard of care. After collecting the signed informed consent form, research participants will be evaluated on the tenth day of device use and re-evaluated on D28 for safety assessment. Recovery time for symptoms related to COVID-19 infection will be measured.
- Conditions
- COVID-19
- Being tested
- Dispersible NaCl powder 10 sessions, Dispersible NaCl powder 5 sessions
- Keywords
- SARS-CoV-2, sodium chloride
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dispersible NaCl powder 10 sessionsDrug
Also called Breathox
Dispersible NaCl powder 10 sessions
Dispersible NaCl powder 5 sessionsDrug
Also called Breathox
Dispersible NaCl powder 5 sessions
| Study group | Role | What they receive |
|---|---|---|
| No intervation | No intervention | Thirty-four subjects receive no intervention. |
| Experimental intervation one | Active comparator | Thirty-three subjects receive dispersible NaCl powder, 8 mg per session per hour (one administration in each nostril and two oral inhalations), totaling 10 times a day, for ten days. Receives: Drug: Dispersible NaCl powder 10 sessions |
| Experimental intervation two | Active comparator | Thirty-three subjects will receive dispersible NaCl powder, 8 mg per session (one administration in each nostril and two oral inhalations) every 3 hours, totaling 5 times a day, for ten days. Receives: Drug: Dispersible NaCl powder 5 sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of symptom clinic improvement
Number of days of symptom clinic improvement
Measured: 10 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 posted19 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzana Erico Tanni Minamoto
- Sponsor type
- University, hospital or other
- Collaborators
- Liita Care ApS
- Responsible party
- Sponsor-investigator, Suzana Erico Tanni Minamoto, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196581
- Sponsor's protocol ID
- BREA01
- Acronym
- BREATH
- Status last verified
- Nov 2023
- First submitted
- 17 Jan 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label Study to Evaluate the Efficacy of Breathox Device Inhalation Therapy 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
- ClinicalTrials.gov ID
- NCT05196581
- Acronym / sponsor ID
- BREATH / BREA01
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, sodium chloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Suzana Erico Tanni MinamotoUniversity, hospital or other
- Collaborators
- Liita Care ApS
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Jan 2022 (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.
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, in vitro intervention with high concentrations of sodium chloride has shown some favorable results in the inactivation of the disease Objective: to determine the effectiveness of inhaled sodium chloride therapy (BREATHOX®) in preventing the use of health resources in patients ≥ 18 years of age in 28 days compared to usual care. Method: Pilot, open randomized clinical trial study, including 100 patients with COVID-19 confirmed and symptomatic with up to 10 days of symptom onset. The included participants will be randomized according to a ratio of 1:1:1 into three groups: (Group 1) Standard of care + BREATHOX® one session (two oral inhalations and more nasal instillation in each nostril) every hour with a total of 10 sessions per day for 10 days; (Group 2) standard of care + BREATHOX® one session (two oral inhalations and more nasal instillation in each nostril) every three hours for a total of 5 sessions per day for 10 days; (Group 3) standard of care. After collecting the signed informed consent form, research participants will be evaluated on the tenth day of device use and re-evaluated on D28 for safety assessment. Recovery time for symptoms related to COVID-19 infection will be measured.
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 | –Thirty-four subjects receive no intervention. |
| Experimental intervation one | Active comparator | Drug: Dispersible NaCl powder 10 sessionsThirty-three subjects receive dispersible NaCl powder, 8 mg per session per hour (one administration in each nostril and two oral inhalations), totaling 10 times a day, for ten days. |
| Experimental intervation two | Active comparator | Drug: Dispersible NaCl powder 5 sessionsThirty-three subjects will receive dispersible NaCl powder, 8 mg per session (one administration in each nostril and two oral inhalations) every 3 hours, totaling 5 times a day, for ten days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult males or females (≥ 18 years of age), not hospitalized, diagnosed with SARS-CoV-2 infection by oropharyngeal RT-PCR or swab antigen test, with mild symptoms of infection.
- Symptomatic subjects must have at least 1 of the following symptoms at inclusion: fever or fever perceived for more than 24 hours, headache, sore throat, nasal obstruction, dry cough, fatigue, chest pain, or choking sensation (no associated respiratory distress ), myalgia, anosmia, ageusia or gastrointestinal symptoms within 10 days of onset;
- Subjects with arterial pulse oximetry (SpO2) saturation ≥ 92% in room air at inclusion;
- Participants with the following hematological and biochemical laboratory parameters obtained within 7 days before D0:
- Hemoglobin > 9.0 g/dL-1
Key exclusion criteria (8 listed)
- Moderate or severe acute respiratory failure, or requiring non-invasive ventilation or oxygen, or with SpO2 <92% or tachypnea (respiratory rate ≥30 breaths/minute);
- Serious and uncontrolled preexisting organ insufficiency, which prevents participation in the study by the investigator's judgment;
- Diagnosis of previous asthma using inhaled or oral corticosteroids in the last four weeks;
- Previous use, in the last ten days of randomization, of inhaled, oral or intravenous corticosteroids; hydroxychloroquine and dewormers.
- Previous diagnosis of chronic obstructive pulmonary disease, even when not using any inhaled medication;
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 |
|---|---|---|
| Dispersible NaCl powder 10 sessionsAlso: BreathoxDispersible NaCl powder 10 sessions | Drug | Experimental intervation one |
| Dispersible NaCl powder 5 sessionsAlso: BreathoxDispersible NaCl powder 5 sessions | Drug | Experimental intervation two |
Primary outcome
Number of days of symptom clinic improvement
Time frame: 10 days after treatment
Number of days of symptom clinic improvement
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 5 Dec 2023.
- Individual participant dataSharing planned: No
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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 Dispersible NaCl powder 10 sessions and Dispersible NaCl powder 5 sessions in people with COVID-19, run by Suzana Erico Tanni Minamoto 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 10 inclusion and 8 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 5 Dec 2023. 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?
Number of days of symptom clinic improvement (time frame: 10 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 5 Dec 2023.