Coronavirus infection, transfusion, C23, A00-B99, Coronavirus OC43, Human.
Conditions
Interventions
40 patients will be treated with convalescent plasma, whose outcomes will be compared with those from a control group of 80 non-transfused patients with the same disease. (total of 120 participants).
Sponsors
Hemocentro de Ribeirão Preto
Hemocentro de Ribeirão Preto
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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 Participant (or his relative) who has withdrawn his consent to participate at any stage of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate in each group on day 30 of orotracheal intubation or diagnosis of respiratory failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time (in days) of mechanical ventilation in both study groups. Time (in days) of hospital stay in the two study groups. Time (in days) of persistence in oro and nasopharynx of covid-19 and viremia in groups submitted to conventional treatment and in the group treated with plasma. Complication index of plasma transfusion in the transfused group. | — |
Countries
Brazil
Contacts
Public ContactGil De Santis
Hemocentro de Ribeirão Preto
Outcome results
None listed