This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 \[COVID-19\] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
350
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2
Facultad de Ciencias Médicas - Universidad Nacional de Asunción
Asunción, Paraguay
Overall survival (30-day mortality)
To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.
Time frame: 30 days
Median length of hospital stay
To describe the median length of hospital stay in days
Time frame: 30 days
Change in clinical status
To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.
Time frame: 0, 3, 7 and 14 days
Change in inflammatory marker: ferritin
To measure changes in ferritin (μg/L) at 0, 7 and 14 days
Time frame: 0, 7 and 14 days
Change in inflammatory marker: D dimer
To measure changes in D dimer (mg/L) at 0, 7 and 14 days
Time frame: 0, 7 and 14 days
Change in inflammatory marker: leukocytes
To measure leukocytes (/mm3) changes at 0, 7 and 14 days
Time frame: 0, 7 and 14 days
Serum Antibody Titers
To measure immunoglobulin G (IgG) SARS-CoV 2 titles
Time frame: 0, 3 and 7 days
Transfer to ICU
To asses the frequency of patients admitted to ICU
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Time frame: 30 days
Transfusion related events
To asses the frequency of adverse events to convalescent plasma
Time frame: 4 hours