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Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545047
Recruitment Status : Completed
First Posted : September 10, 2020
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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).

Condition or disease Intervention/treatment
Coronavirus Disease 2019 (COVID-19) Biological: COVID-19 convalescent plasma

Detailed Description:

The convalescent plasma (CP) of individuals who have recovered from COVID-19 may help reduce symptoms and mortality when given to ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical trials are needed to provide definitive evidence of the benefits and harms of CP in the treatment of COVID-19. While clinical trials are underway, observational research plays a critical role in providing preliminary scientific evidence to guide clinical practice.

This observational study aims to estimate the association between CP therapy and mortality after 30 days in a sample of SARS-CoV-2-positive patients with non-severe illness. Patients include those hospitalized at a facility within the Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA), the largest integrated healthcare system in the United States. Using VA electronic health record data, the study is designed to emulate a target trial of convalescent plasma transfusion and mortality. The primary exposure of interest is the use or non-use of COVID-19 convalescent plasma, and the primary outcome is 30-day all-cause mortality.

A nested trial design will be used, in which patients will be followed from each day in which eligibility criteria are met (while hospitalized and after date of first positive SARS-CoV-2 test) for 30 days. The association between CP therapy and mortality will be assessed using pooled logistic models to estimate 30-day cumulative incidence curves, risk differences, and hazard ratios. Inverse probability weighting derived from propensity scores will be employed to minimize confounding by indication and other biases.

Study Design
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Study Type : Observational
Actual Enrollment : 4755 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: CSP #2030 - Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Exposed
Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility
 Biological: COVID-19 convalescent plasma
Convalescent plasma collected from individuals who have recovered from COVID-19
Unexposed
Veterans who did not receive COVID-19 convalescent plasma therapy


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days ]
    Death from trial start date to 30 days recorded in the electronic health record.


Biospecimen Retention:   None Retained
No biospecimens will be collected

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior intubation, ventilation, high flow oxygen, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545047


Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Mayo Clinic
Investigators
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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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04545047    
Other Study ID Numbers: 2030
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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). Metadata describing the data elements used will be made available on the VA Centralized Interactive Phenomics Resource (CIPHER). 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).

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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
Keywords provided by VA Office of Research and Development:
COVID-19
Antibodies, viral/blood
adult
Human
Retrospective Studies
Immunization, Passive
 Pandemics
Antibodies, Neutralizing
COVID-19 serotherapy
Severe acute respiratory syndrome coronavirus 2
Coronavirus Infections / therapy
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases