COVID-19
Conditions
Interventions
Eligible patients who provide written informed consent may be randomized to receive 250 mL (+10%) plasma (from an immunized donor) with an IgG titer of 1:1000 or greater hyperimmune plasma (experiment
Sponsors
Ministério da Ciência, Tecnologia e Inovações
Pontifícia Universidade Católica do Rio Grande do Sul - PUCRS
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Days free from respiratory support (Supplementary oxygen, CNAF, NIV, MV, ECMO) within 10 days. Measured as per medical record and defined as a day alive and free of respiratory support was defined as any day the patient did not receive supplemental oxygen or invasive or non-invasive mechanical ventilation from randomization to day 10 and will be compared to the control group. (no treatment). Patients who died during the 10-day window will be assigned a value of 0; Number of patients who progress to severe acute respiratory syndrome (defined as a patient with clinical signs of pneumonia – cough, fever, dyspnea or tachypnea, respiratory rate >30 movements/min, PaO2/FiO2 =300 or SpO2 =93% in room air) in both groups on the 28th; Hospitalization (days). Verified according to hospital medical record monitoring and compared to the control group (no treatment); Hospitalization in U.T.I. (days). Verified according to hospital medical record monitoring and compared to the control group (no treatment); Mechanical ventilation (days). Verified according to hospital medical record monitoring and compared to the control group (no treatment); Death. Verified according to hospital medical record monitoring and compared to the control group (no treatment); Frequency of plasma transfusion complications in the transfused group. Verified according to hospital medical record monitoring and compared to the control group (no treatment); Comparative assessment of neutralizing antibody titers between CoronaVac and Oxford/AstraZeneca immunized donors, with or without documented prior SARS-CoV-2 infection. Verified according to hospital medical record monitoring and compared to the control group (no treatment); Predominance of SARS-CoV-2 P.1, P.2, UK, South African, Indiana, and P.4 variants in the recruited patients. Verified according to hospital medical record monitoring and compared to the control group (no treatment); Evolution to the severe acute respiratory syndrome in relation to dete | — |
Countries
Brazil
Contacts
Public ContactMarcus Jones
Outcome results
None listed