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

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ClinicalTrials.gov Identifier: NCT04545047
Recruitment Status : Active, not recruiting
First Posted : September 10, 2020
Last Update Posted : January 20, 2021
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
Estimated Enrollment : 10000 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
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

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 30 days of first SARS-CoV-2 positive test and associated hospital admission
 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 within 30 days of first SARS-CoV-2 positive test and associated admission


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.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 1 year ]
    Long-term outcomes will include death at one year following the index date.


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 at VA Medical Center with a SARS-CoV-2 positive test within 7 days before or after hospital admission
  • Minimum oxygen saturation (measured within the past day) >=90%
  • Currently hospitalized at a VA medical center where CP has been administered to at least 2 patients
  • Admitted during the time when the VA medical center was administering CP therapy
  • Vitals (pulse, respiration, temperature, systolic blood pressure) measured within past 2 days
  • Acute labs (Hemoglobin, platelet, white blood cells) measured within the past 2 days
  • Albumin, ALT, creatinine labs 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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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: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant-level study data will be made available to VA investigators for secondary analyses.
Time Frame: Following publication of the primary manuscript and completion of study objectives
Access Criteria: Data access will contingent upon approval by a review committee and appropriate oversight bodies, such as an IRB and VA R&D Committee. Requestors may be required to sign a Cooperative Studies Program data use agreement.

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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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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases