respiratory diseases
Conditions
Interventions
150 participants will be recruited where 50 will be allocated to a control group and treatment for Covid-19 will be as established by WHO. Another group will consist of 50 participants and the interve
Other
Sponsors
Sociedade Brasileira de ozonioterapia médica
Sociedade Brasileira de ozonioterapia médica
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria for this study are; Patients with acute infectious respiratory symptoms evaluated in hospital or outpatient settings, based on the flow chart suggested by Hospital Israelita Albert Einstein (19.03.2020); Laboratory diagnosis confirmed for Covid-19 (RT-PCR of nasal and / or oropharyngeal secretion) ; Both sexes; Age greater than or equal to 18 years; Signed free and informed consent form; Availability to follow the research protocol
Exclusion criteria
Exclusion criteria: G6PD enzyme deficiency (activity below 60% according to Yoshida classification 242; Pregnancy; Women in lactation Clinically decompensated hyperthyroidism; Severe decompensated arterial hypertension; Severe active or recent bleeding from severe Anemia (Hemoglobin less than 6 g / dL); severe unstable cardiovascular disease ; Participation in another clinical study for less than 30 days; Impossibility of adhering to the research protocol; Any important clinical condition that, in the Investigator's opinion, may bring risks to the patient and prevent him from proceeding safely; Suspected or recent pregnancy as a precaution due to ethical issues, since there are studies of genotoxicity in experimental animals proving the safety of Ozone Therapy in the sense of the absence of genetic changes induced by Medicinal Ozone; any important clinical condition that in the Researcher's opinion may bring risks to the patient and prevent that the research protocol proceeds with safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analyze the time (in days) for the patient to achieve ventilatory independence (dispense any type of ventilatory assistance: be it invasive mechanical ventilation, non-invasive mechanical ventilation or high flow nasal catheter);Analyze the time (in days) to reach a respiratory rate less than or equal to 24 breaths per minute;;Analyze the time (in days) to improve the complete clinic, taking into account the sum (score) of 10 parameters - SOBOM score 02: • fever greater than 37.3 ° C: 1 point; • runny nose / nasal discharge: 1 point; • cough: 1 point; • myalgia: 1 point; • fatigue / prostration: 1 point; | — |
Secondary
| Measure | Time frame |
|---|---|
| Analyze the overall mortality rate; - Length of stay (in days) in the intensive care unit; - Time (in days) for hospital discharge; - Time (in days) of tracheal intubation; - time (in days) to stop the cytokine storm (normalization of C-reactive protein less than 0.1 mg / dL, ESR (men under 50 years less than 15 mm; men over 50 years less than 20 mm, women below 50 years less than 20 mm, women over 50 years less than 30 and ferritin less than 250 mcg / L); - Time (in days) for normalization of coagulopathy (platelets less than 100,000 mm / 3, fibrinogen less than 150 mg / dL and less than 300 mg / dL, D-dimers less than 500 ng / dL and prothrombin time); - Time (in days) for normalization of lymphocyte count below 1,500 / mm3; - Time (in days) for normalization of procalcitonin (less than 0.5 ng / mL); - time of evolution of Lactic Dehydrogenase (DHL); - Evolutionary curves of the neutrophil / lymphocyte (RNL) relationship; - Evolutionary curves of platelet and neutrophil count; - Evolution of plasma creatinine; - Evolutionary dosage of urinary MDA - Monitoring of other laboratory parameters that may be altered; - Time (in days) of corticosteroid use; | — |
Countries
Brazil
Contacts
Public ContactMaria Emilia Serra
Sociedade Brasileira de ozonioterapia médica
Outcome results
None listed