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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-05

No results posted yet for this study

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

Interventions

DRUG

Dispersible NaCl powder 10 sessions

Dispersible NaCl powder 10 sessions

DRUG

Dispersible NaCl powder 5 sessions

Dispersible NaCl powder 5 sessions

Sponsors & Collaborators

  • Liita Care ApS

    collaborator INDUSTRY

  • Suzana Erico Tanni Minamoto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-07-01
Completion
2022-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196581 on ClinicalTrials.gov