Study Testing Convalescent Plasma vs Best Supportive Care
- Conditions
- Pneumonia, Interstitial
- Interventions
- Biological: high-titer anti-Sars-CoV-2 plasmaOther: oxygen therapy
- Registration Number
- NCT04333251
- Lead Sponsor
- Baylor Research Institute
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 115
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description convalescent plasma high-titer anti-Sars-CoV-2 plasma This arm will receive convalescent plasma best supportive care oxygen therapy Oxygen therapy
- Primary Outcome Measures
Name Time Method reduction in oxygen and ventilation support through study completion, an average of 4 weeks reduction in oxygen and ventilation support
- Secondary Outcome Measures
Name Time Method