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Trial - RBR-3k4wxb


Column Value
Trial registration number RBR-3k4wxb
Full text link
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)

Marcos Aurelio Barboza de Oliveira

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

maboliveira@gmail.com

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

2020-05-05

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)

unclear

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)

Positive RT-PCR, age> 18 years, discrete classification (without signs of dyspnea, and oximetry greater than 93%)

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

Need for ICU on day 0, allergy to hydroxychloroquine or azithromycin, retinopathy, G6PD deficiency, QT extension, lactation, pregnancy, hepatic insufficiency, acute renal failure, patients who did not sign the informed consent

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

3

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

Hospital Santo Antônio

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

100

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 disease at enrollment

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

1: Mild 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)

Negative viral load; RT-PCR was taken from a negative oropharynx swab; the RT-PCR value must be literally zero (0) for the patient to be considered cured

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

| Declared number of arm (2.0) differs from found arms (3.0)

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

Phase 2

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

[{"arm_notes": "400mg + azithromycin 500mg bid D0, orally, or enterally, and the following days, hydroxychloroquine 400mg + azithromycin 500mg once each, orally, or enterally", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "200mg + azithromycin 500mg bid D0, orally, or enterally, and the following days, hydroxychloroquine 200mg + azithromycin 500mg once each, orally, or enterally,", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]