Back to resultsStudy Testing Convalescent Plasma vs Best Supportive Care
Primary Purpose
Pneumonia, Interstitial
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
high-titer anti-Sars-CoV-2 plasma
oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Interstitial
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
convalescent plasma
best supportive care
Arm Description
This arm will receive convalescent plasma
Oxygen therapy
Outcomes
Primary Outcome Measures
reduction in oxygen and ventilation support
reduction in oxygen and ventilation support
Secondary Outcome Measures
Full Information
NCT ID
NCT04333251
First Posted
March 27, 2020
Last Updated
April 2, 2020
Sponsor
Baylor Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04333251
Brief Title
Study Testing Convalescent Plasma vs Best Supportive Care
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Interstitial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
convalescent plasma
Arm Type
Experimental
Arm Description
This arm will receive convalescent plasma
Arm Title
best supportive care
Arm Type
Placebo Comparator
Arm Description
Oxygen therapy
Intervention Type
Biological
Intervention Name(s)
high-titer anti-Sars-CoV-2 plasma
Intervention Description
Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer >1:64 vs best supportive care
Intervention Type
Other
Intervention Name(s)
oxygen therapy
Intervention Description
oxygen therapy
Primary Outcome Measure Information:
Title
reduction in oxygen and ventilation support
Description
reduction in oxygen and ventilation support
Time Frame
through study completion, an average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Study Testing Convalescent Plasma vs Best Supportive Care
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