COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-7f4mt9f

Gil De Santis

gil@hemocentro.fmrp.usp.br

2021-03-18

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

Infection confirmed by SARS-CoV-2 (RT-PCR of oro / nasopharyngeal material, or by the detection of IgM-class anti-SARS-CoV-2 antibody, or IgA, associated with a clinical picture suggestive of the disease). respiratory failure: patient on mechanical ventilation or with satO2 ? 93% in room air. Maximum of 10 days from the onset of symptoms. Age between 18 and 80 years. Formal agreement (signing the free and informed consent form- FICF- by the participant or by a member of his family) to participate in the study (it is worth remembering that the majority, or the totality, of the patients will not be in clinical conditions to agree or not to the proposal to participate in the study, therefore, the possibility of acceptance by first-degree relative, or second-degree relative in the absence of the former).

Severe comorbidity (eg, heart failure, kidney failure, sickle cell disease, active cancer). Concomitant infection with another virus (eg HIV, hepatitis B and C virus, HTLV 1/2) or bacteria. History of severe blood transfusion allergy (including patients who have experienced this reaction during the first transfusion, or within six hours after completion, who will then not receive the second dose) will be excluded from the analysis. Participant who received the first dose of plasma within 72 hours of its allocation to the experimental group. Participant (or his relative) who has withdrawn his consent to participate at any stage of the study.

2

Hemocentro de Ribeirão Preto

18

80

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

0

Survival rate in each group on day 30 of orotracheal intubation or diagnosis of respiratory failure.

Phase 2/Phase 3

[{"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"}]