SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Study Overview
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Brief Summary
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Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel coronavirus disease (COVID-19 virus). Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus.

Detailed Description
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Convalescent plasma has been administered to treat different infectious diseases previously with some success. There is currently no approved and proven treatment options available for the novel COVID-19 virus. Some early data has shown a potential benefit in treating hospitalized patients who have tested positive for COVID-19 with convalescent plasma infusions of fresh plasma donated by fully recovered COVID-19 patients. The antibodies present in the recovered patients' plasma may be of benefit in helping critically ill and infected patients recover from the COVID-19 virus. The purpose of this trial is to provide expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as described to patients with severe or life-threatening illness owing to COVID-19.

Official Title
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Severe Acute Respiratory Syndrome Coronavirus 2 of the Genus Betacoronavirus (SARSCoV2) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Conditions
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COVID, SARSCoV2 Convalescent Plasma

Intervention / Treatment
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* Biological: SARSCoV2 Convalescent Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 6 and up Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures. Must have laboratory confirmed COVID-19 positive test 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, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure septic shock, and/or multiple organ dysfunction or failure Exclusion Criteria: Known contraindication to transfusion or history of prior reactions to transfusion of blood products

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: SARSCoV2 Convalescent Plasma|Provide expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as described to patients with severe or life-threatening illness owing to COVID-19.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |