Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2021-03-12

Brief Summary

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This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

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Detailed Description

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Primary objectives are as follows:

1. To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.

Secondary, exploratory objectives are as follows:

1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Convalescent Plasma

The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.

Group Type EXPERIMENTAL

Convalescent Plasma

Intervention Type DRUG

Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.

Interventions

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Convalescent Plasma

Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.

Intervention Type DRUG

Other Intervention Names

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Not appicable

Eligibility Criteria

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Inclusion Criteria

1. Patients must be 18 years of age or older.
2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma.
3. Patient (or legally authorized representative, LAR) is willing and able to provide written informed consent and comply with all protocol requirements.
4. For patients unable to consent, consent by the legally authorized representative (LAR) may be obtained by phone.

Exclusion Criteria

1. Female subjects with positive pregnancy test or breastfeeding.
2. Receipt of pooled immunoglobulin in past 30 days.
3. Contraindication to transfusion or history of prior severe allergic reactions to transfused blood products.
4. On ECMO or in refractory shock at entry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No