Trial registration number
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RBR-2ggx7sm |
Full text link
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://ensaiosclinicos.gov.br/rg/RBR-2ggx7sm
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First author
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Marcus Jones
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Contact
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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mhjones@pucrs.br
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Registration date
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-01-11
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Recruitment status
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Age = 18 years with or without comorbidity, COVID-19 mild (WHO clinical progression scale = 2), Symptoms duration less than 72 hours, Laboratory confirmation of COVID-19, by detecting the viral antigen in respiratory secretions, collected by nasal swab (PanbioTM COVID-19 Ag, Abbott®), Signature, by the patient or a legal representative, of the informed consent form
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Exclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Pregnant women, Patients in palliative care, Refusal to sign the TCLEP, Patients immunized with two doses of the immunizers, with the exception of individuals over 80 years of age who have been immunized with Coronavac vaccine for more than 6 months, Patients with suspected reinfection, Allergic reactions prior to plasma transfusion
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Number of arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Ministério da Ciência; Tecnologia e Inovações
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Inclusion age min
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Brazil
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Type of patients
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild disease at enrollment
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Severity scale
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1: Mild disease at enrollment
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Total sample size
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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0
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primary outcome
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Number of patients requiring hospitalization for complications of SARS-CoV-2 infection on day 28. Measured by monitoring the participant's medical record in case of hospital admission and compared to the control group (no treatment)
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Notes
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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