RBR-5v3k5d
Recruiting
Phase 3
Clinical, Open label, Phase III, Multicenter, Prospective, Comparative, Controlled, Randomized Study to Assess the Effectiveness of Systemic Oxygen Therapy with Medicinal Ozone in Early Control of Disease Progression in Patients with COVID-19 who have Acute Infectious Respiratory Symptoms
Sociedade Brasileira de ozonioterapia médica0 sitesOctober 2, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- respiratory diseases
- Sponsor
- Sociedade Brasileira de ozonioterapia médica
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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