Convalescent Plasma in the Treatment of COVID 19

Study Overview
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Brief Summary
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The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.

Detailed Description
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The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19. 1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19. 2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.

Official Title
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Convalescent Plasma in the Treatment of COVID 19

Conditions
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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), COVID, Coronavirus

Intervention / Treatment
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* Biological: Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All genders Age > 18 yrs and < 90 yrs Must have laboratory confirmed COVID-19 Must provide informed consent Must have severe or immediately life-threatening COVID-19, Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure, septic shock multiple organ dysfunction or failure Exclusion Criteria: No gender exclusion Age < 18 yrs and > 90 yrs COVID-19 negative

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: COVID-19 patients treated with convalescent plasma<br>Severely ill COVID-19 patients treated with convalescent plasma | Biological: Convalescent Plasma<br>* treatment with 2 Units of convalescent plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality within 28 days | Up to 28 days | 
| Viral Load | Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry. The limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene). | Day 0, Day 3, Day 5, and Day 7 | 
| Serum Antibody Titers | Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is > or = 1.0 arbitrary units/mL [AU/mL] (linear reportable range for IgG is 0.20 - 100.00 AU/mL) | Day 0, Day 3, Day 5, and Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma