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

NCT05196581 | Completed Phase 2 DMC

• 1 other identifier: BREA01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

SARS-CoV-2; sodium chloride

Outcome Measures

Primary Outcomes (1)

• Number of days of symptom clinic improvement

  Number of days of symptom clinic improvement

  10 days after treatment

Study Arms (3)

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.

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.

Drug: Dispersible NaCl powder 5 sessions

Interventions

Dispersible NaCl powder 10 sessions DRUG

Dispersible NaCl powder 10 sessions

Also known as: Breathox

Experimental intervation one

Dispersible NaCl powder 5 sessions DRUG

Dispersible NaCl powder 5 sessions

Also known as: Breathox

Experimental intervation two

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. 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.
• D. 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
• 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;
• E. Participants must be able and willing to comply with study visits and procedures as per protocol.

You may not qualify if:

• A. Moderate or severe acute respiratory failure, or requiring non-invasive ventilation or oxygen, or with SpO2 \<92% or tachypnea (respiratory rate ≥30 breaths/minute);
• B. Serious and uncontrolled preexisting organ insufficiency, which prevents participation in the study by the investigator's judgment;
• C. Diagnosis of previous asthma using inhaled or oral corticosteroids in the last four weeks;
• D. Previous use, in the last ten days of randomization, of inhaled, oral or intravenous corticosteroids; hydroxychloroquine and dewormers.
• E. Previous diagnosis of chronic obstructive pulmonary disease, even when not using any inhaled medication;
• F. Pregnant or lactating women;
• G. 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;
• H. Any condition that, in the investigator's opinion, could compromise the participant's safety or adherence to the study protocol.

Sponsors & Collaborators

• Suzana Erico Tanni Minamoto: lead
• Liita Care ApS: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18618687, Brazil

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

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

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)