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Trial - RBR-7d7ngw


Column Value
Trial registration number RBR-7d7ngw
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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)

Jorge Luis Dos Anjos

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

jorgelmanjos@hotmail.com

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

2020-08-07

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

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)

Patients will be included in surveys over the age of 18, are available hemodynamically, with arterial oxygen saturation greater than or equal to 94%, temperature below 38.5 degrees, Respiratory rate below 30 breaths per minute, who are on spontaneous ventilation to the environment or using oxygen support.

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

Patients who do not have a confirmed diagnosis of COVID-19 will be excluded, patients with severe acute arrhythmias, with a history of hemodynamic instability or recent cardiorespiratory arrest, Recent cardiothoracic surgery or unstable chest, Polytrauma with unstabilized fractures, Pregnant women, Recent abdominal surgery or stoma formation.

Number of arms
Last imported at : Dec. 15, 2020, 2:47 p.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)

Hospital Geral Roberto Santos

Inclusion age min
Last imported at : Dec. 15, 2020, 2:47 p.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/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 of the need for orotracheal intubation and invasive mechanical ventilation in patients submitted to early prone position; verified by measuring epidemiological variables such as relative risk; absolute risk and the number needed to treat; based on the finding of a difference of at least 10 per between groups.;Fewer deaths in patients submitted to early prone position; verified by measuring epidemiological variables such as relative risk; absolute risk and the number needed to treat; based on the observation of a difference of at least 10 percent between the groups.

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 2/Phase 3

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

[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory 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"}]