Study Testing Convalescent Plasma vs Best Supportive Care

Baylor Research Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Pneumonia, Interstitial

Interventions

high-titer anti-Sars-CoV-2 plasmaBIOLOGICAL

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

oxygen therapyOTHER

oxygen therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Donor: * 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 Inclusion Criteria Recipient: * 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

Outcomes

Primary Outcomes

reduction in oxygen and ventilation support

Time frame: through study completion, an average of 4 weeks

Data from ClinicalTrials.gov

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