Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Plasma Therapy
- Sponsor
- Enos Bernasconi
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Investigators
Enos Bernasconi
Prof Dr med
Ente Ospedaliero Cantonale, Bellinzona
Eligibility Criteria
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.
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
Time Frame: Change from day of diagnosis at day 1
Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7
Secondary Outcomes
- Number of patients with improvement in the 7-points Ordinal Scale(At day 7)
- Proportion of patients with adverse events, severity of adverse events(At day 21)