Pneumonia, Interstitial
Conditions
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.
Interventions
BIOLOGICALhigh-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
OTHERoxygen therapy
oxygen therapy
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in oxygen and ventilation support | through study completion, an average of 4 weeks | reduction in oxygen and ventilation support |
Outcome results
None listed