Use of Convalescent Plasma for COVID-19

NCT ID: NCT04408040

Last Updated: 2022-11-14

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2021-09-14

Brief Summary

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The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.

Detailed Description

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Conditions

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COVID

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Critical Patients

Group Type OTHER

Convalescent Plasma

Intervention Type BIOLOGICAL

200-425mL convalescent plasma donated by patients previously positive for COVID-19

Severe Patients

Group Type OTHER

Convalescent Plasma

Intervention Type BIOLOGICAL

200-425mL convalescent plasma donated by patients previously positive for COVID-19

High Risk

Group Type OTHER

Convalescent Plasma

Intervention Type BIOLOGICAL

200-425mL convalescent plasma donated by patients previously positive for COVID-19

Health Care Providers

Group Type OTHER

Convalescent Plasma

Intervention Type BIOLOGICAL

200-425mL convalescent plasma donated by patients previously positive for COVID-19

Interventions

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Convalescent Plasma

200-425mL convalescent plasma donated by patients previously positive for COVID-19

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Documented COVID-19 infection by nasal pharyngeal sampling
* COVID-19 disease falling into one of the following groups:
* Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure
* Severe disease: tachypnea \>/=30 per min, O2 sats \</=93% at rest, PaO2/FiO2 index \</=300mmHg
* High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI \>/=40, age \>/=65 years
* Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease

Exclusion Criteria

* History of IgA deficiency
* History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northside Hospital, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kent Holland, MD

Role: PRINCIPAL_INVESTIGATOR

Northside Hospital

Locations

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Northside Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NSH 1281

Identifier Type: -

Identifier Source: org_study_id

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