Study Stopped
Study stopped due to opening Expanded Access Protocol.
Convalescent Plasma to Limit Coronavirus Associated Complications
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 8, 2020
April 1, 2020
2.8 years
March 26, 2020
April 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
RNA in SARS-CoV-2
Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
ICU Admissions
Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
90 days after transfusion
Hospital Mortality
Total number of subject deaths.
90 days after transfusion
Hospital Length of Stay (LOS)
The total number of days subjects were admitted to the hospital.
90 days after transfusion
Secondary Outcomes (2)
Type of respiratory support
90 days after transfusion or until hospital discharge (whichever comes first)
Duration of respiratory support
90 days after transfusion or until hospital discharge (whichever comes first)
Study Arms (1)
Convalescent Plasma Group
EXPERIMENTALSubjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of \>1:64.
Interventions
Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers \>1:64.
Eligibility Criteria
You may qualify if:
- Patients must be 18 years of age or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
- Patient agrees to storage of specimens for future testing.
You may not qualify if:
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Joyner, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 27, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 8, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share