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
|Condition or disease||Intervention/treatment|
|Coronavirus Disease 2019 (COVID-19)||Biological: COVID-19 convalescent plasma|
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 Type :||Observational|
|Estimated Enrollment :||10000 participants|
|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|
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
Veterans who did not receive COVID-19 convalescent plasma therapy within 30 days of first SARS-CoV-2 positive test and associated admission
- All-cause mortality [ Time Frame: 30 days ]Death from trial start date to 30 days recorded in the electronic health record.
- All-cause mortality [ Time Frame: 1 year ]Long-term outcomes will include death at one year following the index date.
Biospecimen Retention: None Retained
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
|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|
|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|