Convalescent Plasma for COVID-19

Not Applicable

• Conditions: Blood Plasma Therapy; COVID
• Interventions: Biological: Blood plasma

• Registration Number: NCT04365439
• Lead Sponsor: Enos Bernasconi

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-26
• Study First Posted: 2020-04-28
• Study Start: 2020-07-20
• Primary Completion: 2020-12-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convalescent plasma	Blood plasma	Convalescent plasma from patients after COVID-19

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ospedale Regionale Locarno; 🇨🇭 Locarno, Ticino, Switzerland