COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5r8gv8p

André Nicola

amnicola@unb.br

2021-07-07

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Plasma donor: be between 18 and 60 years old, be male or a female that has never been pregnant, weight at least 60 kg, have SARS-CoV-2 infection confirmed by positive RT-PCR, be eligible for blood donation, according to the appropriate Brazilian law (Seção II da Portaria de Consolidação n.5, de 28 de setembro de 2017), agree to participate in the study and sign the informed consent form(s), have no Covid-19 symptoms for 14-27 days, in which case a new RT-PCR test from a nasopharyngeal or oropharyngeal swab has to be negative OR have no Covid-19 symptoms for 28 days or more, in which case no additional tests are necessary, have a positive result on a SAR-CoV-2 IgG test. Plasma transfusion receptor: be 18 years or older, have been admitted to a hospital to treat moderate Covid-19, defined as compatible clinical characteristics, such as dyspnea and/or fever and/or cough plus chest computed tomography with bilateral ground glass opacities, have SARS-CoV-2 infection confirmed by nasopharyngeal and/or oropharyngeal swab PCR or serological assay that detects IgM or SARS-CoV-2 antigen, have Covid-19 symptoms for no more than 10 days.

Plasma donor: at the interview and research subject selection stage: history of severe Covid-19 in the last 30 days (septic shock, cardiac arrest or intubation for more than two days), previous history of coagulation diseases than could increase the venous access risk, previous history of hemoglobinopathies that could increase the plasmapheresis risk, situations that prohibit blood donations, according to Brazilian law (Portaria de Consolidação n.5, de 28 de setembro de 2017). At the pre-plasmapheresis stage: positive result in an irregular antibody test made with serum collected during triage, detection of anomalous hemoglobin (e.g. sickle cell trait) in a whole blood sample obtained during triage, negative result on a test for SARS-CoV-2 IgG, ineligibility for blood donation identified during triage, as specified at the relevant Brazilian law (Portaria de Consolidação n.5, de 28 de setembro de 2017). Plasma transfusion receptor: respiratory insufficiency with indication for mechanical ventilation, severe sepsis or septic shock, active co-infection with a dengue virus, confirmed by serological detection of the NS1 antigen or RT-PCR, admission to the Intensive Care Unit (ICU), having received intravenous immunoglobulin (IVIG) in the last 30 days, history of allergy or hypersensitivity to a blood product transfusion, heart or renal insufficiencies that makes the excess volume from plasma transfusion not advisable, in women, present pregnancy, plans to get pregnant in the following two months or breastfeeding, be part of another clinical trial.

2

Universidade de Brasília

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

Decrease in the proportion of patients who progress to severe Covid-19; defined as a need for intubation by the medical team.

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]