Hyperimmune Plasma for Patients With COVID-19

Study Overview
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Brief Summary
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The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Detailed Description
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Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males and womens , age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately. Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Official Title
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The Use of Hyperimmune Plasma for the Treatment of COVID-19 Infection

Conditions
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Covid19

Intervention / Treatment
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* Other: treated with hyperimmune plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >=18 yrs positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2 Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days Polymerase chain reaction (PCR) positive signed informed consent unless unfeasible for the critical condition Exclusion Criteria: proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins consent denied

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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Accepts Healthy Volunteers

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: Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperimmune plasma<br>treated with hyperimmune plasma | Other: treated with hyperimmune plasma<br>* administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5<br>* Other names: hyperimmune plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | death from any cause | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to extubation | days since intubation | within 7 days | 
| length of intensive care unit stay | days from entry to exit from ICU | within 7 days | 
| length of hospitalization | days from entry to exit from hospital | within 30 days | 
| immune response | neutralizing title | at days 1, 3 and 7 | 
| viral load | naso-pharyngeal swab and BAL | at days 1, 3 and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, Hospitalized patients, Hyperimmune plasma