Convalescent Plasma for COVID-19

Enos Bernasconi11 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Blood Plasma Therapy COVID

Interventions

Blood plasmaBIOLOGICAL

Convalescent plasma after COVID-19

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ospedale Regionale Locarno

Locarno, Canton Ticino, Switzerland

Outcomes

Primary Outcomes

Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors

Time frame: At plasma donation

Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma

Time frame: Change from baseline at day 21

Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)

Time frame: 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

Time frame: Change from day of diagnosis at day 1

Secondary Outcomes

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

Time frame: 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.

Time frame: At day 21

Data from ClinicalTrials.gov

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