COVID-19 Infection, SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2 infection, Convalescent plasma
Brief summary
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).
Interventions
BIOLOGICALConvalescent plasma
COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2
Sponsors
Consejo Nacional de Ciencias y Tecnología, Paraguay
Ministerio de Salud Pública y Bienestar Social, Paraguay
Centro de información y recursos para el desarrollo, Paraguay
Universidad Nacional de Asunción
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 Years and older * Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR) * Patients with no more than 15 days from the onset of symptoms * Signed informed consent
Exclusion criteria
* Severely ill patients admitted directly to the ICU. * Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution. * History of previous hypersensitivity to plasma transfusions. * History of immunoglobulin A (IgA) deficiency * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (30-day mortality) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical status | 0, 3, 7 and 14 days | To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance. |
| Change in inflammatory marker: ferritin | 0, 7 and 14 days | To measure changes in ferritin (μg/L) at 0, 7 and 14 days |
| Change in inflammatory marker: D dimer | 0, 7 and 14 days | To measure changes in D dimer (mg/L) at 0, 7 and 14 days |
| Median length of hospital stay | 30 days | To describe the median length of hospital stay in days |
| Serum Antibody Titers | 0, 3 and 7 days | To measure immunoglobulin G (IgG) SARS-CoV 2 titles |
| Transfer to ICU | 30 days | To asses the frequency of patients admitted to ICU |
| Transfusion related events | 4 hours | To asses the frequency of adverse events to convalescent plasma |
| Change in inflammatory marker: leukocytes | 0, 7 and 14 days | To measure leukocytes (/mm3) changes at 0, 7 and 14 days |
Countries
Paraguay
Outcome results
None listed