Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
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ClinicalTrials.gov Identifier: NCT04545047 |
Recruitment Status :
Completed
First Posted : September 10, 2020
Last Update Posted : July 19, 2022
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Condition or disease | Intervention/treatment |
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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 |
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 |

Group/Cohort | Intervention/treatment |
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Exposed
Veterans who received COVID-19 convalescent plasma therapy within 2 days of eligibility
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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
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- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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 |
Publications of Results:
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). |
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 |
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 |
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 |