Convalescent Plasma for COVID-19

Enos Bernasconi

Status: Unknown

Conditions: Blood Plasma Therapy; COVID

Treatments: Biological: Blood plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04365439

2020-00895

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Convalescent plasma

Experimental group

Description:

Convalescent plasma from patients after COVID-19

Treatment:

Biological: Blood plasma