Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

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).
    

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.
    

Intervention name(s): COVID-19 convalescent plasma
Intervention type(s): Biological
Intervention description(s): Convalescent plasma collected from individuals who have recovered from COVID-19
Observational model: Other
Time perspective: Prospective
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
      
Biospecimen description: 
      No biospecimens will be collected
    
Keywords: 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