A Phase 2/3 interventional study of Convalescent plasma in SARS-CoV-2 Infection and COVID-19 Infection, sponsored by Universidad Nacional de Asunción. Completed at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Universidad Nacional de Asunción · Phase 2/3, Interventional, and Treatment
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).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 350 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Universidad Nacional de Asunción is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
COVID-19 convalescent plasma
Biological: Convalescent plasma
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2
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
Time frame: 30 days
Transfusion related events
To asses the frequency of adverse events to convalescent plasma
Time frame: 4 hours
Plan to share: No — The investigators will publish the results to compare data with other studies with COVID-19 convalescent plasma patients
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Asunción