COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5v3k5d

Maria Emilia Serra

emilia.gadelha1@gmail.com

2020-10-02

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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

3

Sociedade Brasileira de ozonioterapia médica

18

90

Brazil

No restriction on type of patients

0: No restriction on type of patients

0

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;

Phase 3

[{"arm_notes": "", "treatment_id": 952, "treatment_name": "Ozone therapy", "treatment_type": "Others non pharmacological treatment", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 951, "treatment_name": "Ozonated autohemotherapy", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]