Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

Study Overview
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Brief Summary
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This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.

Detailed Description
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Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response. Subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.

Official Title
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Convalescent Plasma for the Treatment of Coronavirus Disease 2019

Conditions
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Covid19

Intervention / Treatment
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* Biological: COVID 19 Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds) Exclusion Criteria: History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module [see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf]. Has underlying uncompensated and untreatable end stage disease. Fluid overload or other condition that would contraindicate administration of plasma

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
Interventional Model Description: Given that this is a pilot study to evaluate the safety of treatment with convalescent COVID-19 plasma versus standard care in subjects with severe and/or critical COVID-19 between the cases and historical controls without predetermined data, a convenient sample size of 700 patients (350 per group) has been proposed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All subjects recruited will be transfused with COVID 19 convalescent plasma. A prospective comparison with matched historical controls receiving standard care will be employed. | Biological: COVID 19 Convalescent Plasma<br>* COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of serious adverse events related to the treatment intervention. | Total number of grade 3 and above throughout study period | up to 60 days post-transfusion | 
| Mortality at Day 28 post-hospital admission. | All cause mortality at day 28 | up to 28 days post-transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Total number of days subjects are hospitalized during study period | up to 60 days post-transfusion | 
| Length of supplemental oxygen requirement. | Total number of days subjects requires supplemental oxygen during study period | up to 60 days post-transfusion | 
| Length of mechanical ventilation requirement. | Total number of days subjects require mechanical ventilation during study period | up to 60 days post-transfusion | 
| Length of ICU stay | Total number of days subject is subject stays in the ICU | up to 60 days post-transfusion |