Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
CSP #2030 - Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
1 other identifier
observational
5,044
1 country
2
Brief Summary
The purpose of this study is to assess whether convalescent plasma therapy is associated with reduced 30-day all-cause mortality in a population of Veteran inpatients with non-severe coronavirus disease 2019 (COVID-19).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedResults Posted
Study results publicly available
April 4, 2024
CompletedApril 4, 2024
April 1, 2024
1.4 years
September 9, 2020
September 14, 2022
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause Mortality
Death at 30 days recorded in the electronic health record. Follow-up starts at the treatment date, which must be within 2 days after both hospitalization and SARS-CoV-2-positive test, and ends at 30 days or death.
30 days
Study Arms (2)
Exposed
Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility
Unexposed
Veterans who did not receive COVID-19 convalescent plasma therapy
Interventions
Convalescent plasma collected from individuals who have recovered from COVID-19
Eligibility Criteria
Veterans with non-severe COVID-19 who tested positive for SARS-CoV-2 infection during admission at a VA medical center or who were admitted as inpatients to a VA medical center within 30 days after a positive test for SARS-CoV-2 infection
You may qualify if:
- US Veterans aged 21-80 years old
- Hospitalized between May 1, 2020 and November 17, 2020 with a SARS-CoV-2 positive test, at a VA Medical Center where convalescent plasma had been administered to at least one patient and remained a current practice at that VA Medical Center
- SARS-CoV-2 positive test within 7 days before or after hospital admission
- Minimum oxygen saturation (measured within the past day) \>=90%
- Vitals (pulse, respiration, temperature, systolic blood pressure) and acute labs (hemoglobin, platelet, white blood cells) measured within the past 2 days
- Albumin, Alanine Aminotransferase (ALT), creatinine measured within the past 30 days
- Weight measurement recorded in the past 2 years
You may not qualify if:
- Prior intubation, ventilation, high flow oxygen, extracorporeal membrane oxygenation (ECMO), dialysis, or vasopressors during current hospitalization
- Record of prior treatment with CP
- Received long-term care in a domiciliary or nursing home in the past 90 days
- First CP recipient at a site
- Less than 30 days of follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Mayo Cliniccollaborator
Study Sites (2)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
Related Publications (1)
Cho K, Keithly SC, Kurgansky KE, Madenci AL, Gerlovin H, Marucci-Wellman H, Doubleday A, Thomas ER, Park Y, Ho YL, Sugimoto JD, Moore KP, Peterson AC, Hoag C, Gupta K, Jeans K, Klote M, Ramoni R, Huang GD, Casas JP, Gagnon DR, Hernan MA, Smith NL, Gaziano JM. Early Convalescent Plasma Therapy and Mortality Among US Veterans Hospitalized With Nonsevere COVID-19: An Observational Analysis Emulating a Target Trial. J Infect Dis. 2021 Sep 17;224(6):967-975. doi: 10.1093/infdis/jiab330.
PMID: 34153099RESULT
Related Links
Biospecimen
No biospecimens will be collected
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Manager
- Organization
- VA Cooperative Studies Program
Study Officials
- STUDY CHAIR
Nicholas L. Smith, PhD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
- STUDY CHAIR
Michael J Gaziano, MD MPH
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 10, 2020
Study Start
May 1, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
April 4, 2024
Results First Posted
April 4, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
Data on SARS-CoV-2 testing, COVID-19 treatment, comorbidities, and other COVID-19-related information are available through the VA COVID-19 Shared Data Resource data domain within the VA Corporate Data Warehouse (CDW). Veterans Health Administration (VHA) researchers can request access to VHA data sources and data access tools for a research protocol approved by a VA Research and Development (R\&D) Committee and reviewed by an Institutional Review Board (IRB). Information about requesting access to http://vaww.vhadataportal.med.va.gov/DataAccess/ResearchAcces (internal to VA).