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Trial - RBR-97nt6j


Column Value
Trial registration number RBR-97nt6j
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Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Arnoldo Souza

Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

arnoldos@cardiol.br

Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-09-24

Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Man and women Age between 18 and 90 years, Signature of the informed consent form (ICF). COVID-19 positive PCR (Swab) exam

Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Pregnancy, especially in the beginning, Individuals who continuously use immunosuppressants or have been transplanted for less than 6 months, Individuals participating in other clinical studies. Symptoms of severe acute respiratory syndrome (SARS) and / or comorbidities according to the regulations of the Ministry of Health (Guidelines for Diagnosis and Treatment for COVID-19, version 1 of April 6, 2020), with suspicion of COVID-19, with Covid RT-PCR -19

Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Dec. 15, 2020, 2:47 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Associação Brasileira de Ozonioterapia

Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

90

Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Brazil

Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Dec. 15, 2020, 2:47 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

0

primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Reduction in the percentage of patients with suspected / confirmed COVID 19 who evolve to more severe forms (need for hospitalization and / or mechanical ventilation) with an increase in the recovery rate of these patients in the group who underwent ozone therapy.

Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Nov. 13, 2021, 5:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 1/Phase 2

Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 952, "treatment_name": "Ozone therapy", "treatment_type": "Others non pharmacological treatment", "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"}]