COVID-19
Conditions
Interventions
Experimental group: 100 adult inpatients with moderate Covid-19 will receive a transfusion of a single unit of plasma that was collected from a person who survived Covid-19.Control group: 100 adult in
D016913
Sponsors
Universidade de Brasília
Fundação Hemocentro de Brasília
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in the proportion of patients who progress to severe Covid-19, defined as a need for intubation by the medical team. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in the time to intensive care unit (ICU) admission, measured between admission as inpatient and indication of the necessity of transfer to an ICU by the medical team.;Decrease in the time to intubation, measured between admission as inpatient and indication of the necessity of mechanical ventilation by the medical team.;Increase in the survival time, measured between admission as inpatient and in-hospital death.;Decrease in the time to discharge, measured between admission and discharge after resolution of the acute disease.;Decrease in mortality in 28 days, defined as death by any cause within the 28 days after hospital admission. | — |
Countries
Brazil
Contacts
Public ContactAndré Nicola
Universidade de Brasília
Outcome results
None listed