Official Title
Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19
Brief Summary

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.

Detailed Description

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.

Unknown status
Pneumonia, Interstitial

Biological: 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

Other: oxygen therapy

oxygen therapy

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Baylor Research Institute
NCT Number
MeSH Terms
Pneumonia
Lung Diseases, Interstitial