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Trial - RBR-6wgwxsy


Column Value
Trial registration number RBR-6wgwxsy
Full text link
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Evônio Campelo

Contact
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

evoniocampelo55@gmail.com

Registration date
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2022-03-14

Recruitment status
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

outpacients with positive diagnosis for COVID-19

Exclusion criteria
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Patients with indication for hospital admission, patients with other protease inhibitors, pregnant, infants, more than 5 days from the onset of symptoms, HIV positive patients

Number of arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

3

Funding
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Hospital das Clínicas da Universidade Federal de Pernambuco

Inclusion age min
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Brazil

Type of patients
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild disease at enrollment

Severity scale
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1: Mild disease at enrollment

Total sample size
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

953

primary outcome
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

To evaluate the number of hospitalizations; verified by the percentage of hospitalization of the experimental and control groups; based on a finding of a variation of at least 5% in pre- and post-intervention measurements.;To evaluate hospital discharge rate; verified by the percentage of discharge rate of the experimental and control groups; based on a finding of a variation of at least 5% in pre- and post-intervention measurements.;To evaluate hospital death rate; verified by the percentage of death rate of the experimental and control groups; based on a finding of a variation of at least 5% in pre- and post-intervention measurements.

Notes
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 2

Arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 2427, "treatment_name": "Atazanavir+doxycycline+ritonavir", "treatment_type": "Antivirals+antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1422, "treatment_name": "Atazanavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]