COVID-19 Convalescent Plasma Therapy

Study Overview
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Brief Summary
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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).

Official Title
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COVID-19 Convalescent Plasma Therapy

Conditions
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SARS-CoV-2 Infection, COVID-19 Infection

Intervention / Treatment
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* Biological: Convalescent plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent plasma<br>COVID-19 convalescent plasma | Biological: Convalescent plasma<br>* COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median length of hospital stay | To describe the median length of hospital stay in days | 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. | 0, 3, 7 and 14 days | 
| Change in inflammatory marker: ferritin | To measure changes in ferritin (μg/L) at 0, 7 and 14 days | 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 | 0, 7 and 14 days | 
| Change in inflammatory marker: leukocytes | To measure leukocytes (/mm3) changes at 0, 7 and 14 days | 0, 7 and 14 days | 
| Serum Antibody Titers | To measure immunoglobulin G (IgG) SARS-CoV 2 titles | 0, 3 and 7 days | 
| Transfer to ICU | To asses the frequency of patients admitted to ICU | 30 days | 
| Transfusion related events | To asses the frequency of adverse events to convalescent plasma | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 infection, Convalescent plasma