Convalescent Plasma to Limit Coronavirus Associated Complications
April 6, 2020 updated by: Michael J. Joyner, M.D., Mayo Clinic
Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
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.
Study Overview
Detailed Description
High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients.
An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Convalescent Plasma Group
Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64.
|
Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RNA in SARS-CoV-2
Time Frame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
|
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
Time Frame: 90 days after transfusion
|
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
Time Frame: 90 days after transfusion
|
Total number of subject deaths.
|
90 days after transfusion
|
|
Hospital Length of Stay (LOS)
Time Frame: 90 days after transfusion
|
The total number of days subjects were admitted to the hospital.
|
90 days after transfusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of respiratory support
Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first)
|
The type of supplemental oxygen support (e.g.
nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
|
90 days after transfusion or until hospital discharge (whichever comes first)
|
|
Duration of respiratory support
Time Frame: 90 days after transfusion or until hospital discharge (whichever comes first)
|
The total number of days subjects required respiratory support.
|
90 days after transfusion or until hospital discharge (whichever comes first)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2020
Last Update Submitted That Met QC Criteria
April 6, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-002864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.