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 (BREATH)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Dispersible NaCl powder 10 sessions; Drug: Dispersible NaCl powder 5 sessions

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Suzana Minamoto, Ph.D.; Phone Number: +551438801663; Email: suzana.tanni@unesp.br
• Study Contact Backup: Name: Luana Pagan, PhD; Phone Number: +551438801663; Email: luanapagan@alunos.fmb.unesp.br

Study Locations

• Brazil
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618687
      • Hospital das Clínicas da Faculdade de Medicina de Botucatu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

B. 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;

C. Subjects with arterial pulse oximetry (SpO2) saturation ≥ 92% in room air at inclusion;

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervation; Thirty-four subjects receive no intervention.
Active Comparator: Experimental intervation one; 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; Dispersible NaCl powder 10 sessions; Other Names: Breathox
Active Comparator: Experimental intervation two; 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; Dispersible NaCl powder 5 sessions; Other Names: Breathox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of symptom clinic improvement	Number of days of symptom clinic improvement	10 days after treatment

Collaborators and Investigators

• Sponsor: Suzana Erico Tanni Minamoto
• Collaborators: Liita Care ApS

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; sodium chloride
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BREA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No