Status:
UNKNOWN
Study Testing Convalescent Plasma vs Best Supportive Care
Lead Sponsor:
Baylor Research Institute
Conditions:
Pneumonia, Interstitial
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 antic...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04333251
Start Date
April 1 2020
End Date
December 31 2022
Last Update
April 6 2020
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