Convalescent Plasma for COVID-19

Study Overview
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Brief Summary
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The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess: the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment; the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment; the impact of plasma transfusion on the reduction of viral load and inflammation safety and tolerability clinical efficacy

Official Title
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Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study

Conditions
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Blood Plasma Therapy, COVID

Intervention / Treatment
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* Biological: Blood plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized adult patients 18 - 75 y.o. with confirmed COVID-19 infection by nasopharyngeal swab; radiologically confirmed pneumonia; SpO2 > 92o/o and < 96% (room air); ongoing thromboembolic prophylaxis. Exclusion Criteria: Participation to another COVID-19 trial; severe COVID-19 disease (SpO2 < 93o/o in room air); severe allergic transfusion reactions or anaphylaxis in the patient history; documented lgA deficiency; unstable heart disease with signs of circulatory overload; malignancies or other concomitant diseases with poor short-term prognosis; pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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>Convalescent plasma from patients after COVID-19 | Biological: Blood plasma<br>* Convalescent plasma after COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors |  | At plasma donation | 
| Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma |  | Change from baseline at day 21 | 
| Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1) |  | Change from baseline at day 7 | 
| Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs | Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7 | Change from day of diagnosis at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improvement in the 7-points Ordinal Scale | 7-point ordinal scale measure on day 0 (Baseline), day 1, 3 and 7 after plasma transfusion | At day 7 | 
| Proportion of patients with adverse events, severity of adverse events | AE will be assessed by the DAIDS scale on day 1, 3, 7 and 21. Relatedness with plasma transfusion will also be reported. | At day 21 |