Study Testing Convalescent Plasma vs Best Supportive Care

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-17

Study Completion Date

2021-09-07

Brief Summary

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Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.

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Detailed Description

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Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.

Conditions

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Pneumonia, Interstitial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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convalescent plasma

This arm will receive convalescent plasma

Group Type EXPERIMENTAL

high-titer anti-Sars-CoV-2 plasma

Intervention Type BIOLOGICAL

Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer \>1:64 vs best supportive care

best supportive care

Oxygen therapy

Group Type PLACEBO_COMPARATOR

oxygen therapy

Intervention Type OTHER

oxygen therapy

Interventions

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high-titer anti-Sars-CoV-2 plasma

Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer \>1:64 vs best supportive care

Intervention Type BIOLOGICAL

oxygen therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
* females of child-bearing potential must have a negative serum pregnancy test
* subject and/or LAR willing to provide informed consent
* patient agrees to storage of specimens for future testing

* 18 years or older
* must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness
* subject and/or LAR willing to provide informed consent
* patient agrees to storage of specimens for future testing

Exclusion Criteria

* 18 years or older
* receipt of pooled immunoglobulin in past 30 days
* contraindication to transfusion or history of prior reactions to transfusion blood products
* females who are identified as donors must not be pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No