Convalescent Plasma for COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Blood Plasma Therapy COVID

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent plasma

Convalescent plasma from patients after COVID-19

Group Type EXPERIMENTAL

Blood plasma

Intervention Type BIOLOGICAL

Convalescent plasma after COVID-19

Interventions

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Blood plasma

Convalescent plasma after COVID-19

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No