COVID-19 Convalescent Plasma

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

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2020-12-23

Brief Summary

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The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.

Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.

Hypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.

Objective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.

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Detailed Description

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Conditions

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Coronavirus

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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Treatment with anti-SARS-CoV-2 convalescent plasma

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Group Type EXPERIMENTAL

anti-SARS-CoV-2 convalescent plasma

Intervention Type BIOLOGICAL

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Interventions

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anti-SARS-CoV-2 convalescent plasma

Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \~300 mL over 4 hours

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age greater or equal to 18
* Able to donate blood per blood bank standard guidelines
* Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)
* Complete resolution of symptoms at least 28 days prior to donation
* Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors

* Patients must be 18 years of age or older
* Must have laboratory-confirmed COVID-19
* Must have severe or immediately life-threatening COVID-19

* Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or lung infiltrates \> 50% within 24 to 48 hours
* Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.
* Must be less than 21 days from the start of illness
* Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act
* Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.
* Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma

Exclusion Criteria

* Does not provide consent
* Does not meet standard blood bank donation guidelines
* Unsuccessful blood donation

* Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
* Receipt of pooled immunoglobulin in past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products
* Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No