NCT04747158CompletedPhase 2
COVID-19 Convalescent Plasma Therapy
Universidad Nacional de Asunción2 sites in 1 country350 target enrollmentStarted: August 10, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 350
- Locations
- 2
- Primary Endpoint
- Overall survival (30-day mortality)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Overall survival (30-day mortality)
Time Frame: 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 Outcomes
- Change in inflammatory marker: ferritin(0, 7 and 14 days)
- Median length of hospital stay(30 days)
- Change in clinical status(0, 3, 7 and 14 days)
- Change in inflammatory marker: D dimer(0, 7 and 14 days)
- Change in inflammatory marker: leukocytes(0, 7 and 14 days)
- Serum Antibody Titers(0, 3 and 7 days)
- Transfer to ICU(30 days)
- Transfusion related events(4 hours)
Investigators
Study Sites (2)
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