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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT04545047
Collaborator
Mayo Clinic (Other)
4,755
Enrollment
2
Locations
17
Actual Duration (Months)
2377.5
Patients Per Site
139.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Oct 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. All-cause mortality [30 days]

    Death from trial start date to 30 days recorded in the electronic health record.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130
2 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

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04545047
Other Study ID Numbers:
  • 2030
First Posted:
Sep 10, 2020
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
COVID-19
Coronavirus Infections

Study Results

No Results Posted as of Jul 19, 2022