Blood Plasma Therapy, COVID
Conditions
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
Interventions
BIOLOGICALBlood plasma
Convalescent plasma after COVID-19
Sponsors
Enos Bernasconi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with improvement in the 7-points Ordinal Scale | At day 7 | 7-point ordinal scale measure on day 0 (Baseline), day 1, 3 and 7 after plasma transfusion |
| Proportion of patients with adverse events, severity of adverse events | At day 21 | AE will be assessed by the DAIDS scale on day 1, 3, 7 and 21. Relatedness with plasma transfusion will also be reported. |
Countries
Switzerland
Outcome results
None listed