Status:
COMPLETED
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
Lead Sponsor:
Suzana Erico Tanni Minamoto
Collaborating Sponsors:
Liita Care ApS
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 interven...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05196581
Start Date
December 1 2021
End Date
December 31 2022
Last Update
December 5 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil, 18618687