Clinical trial NCT04545047: Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Official title: CSP #2030 - Observational Study of Convalescent Plasma for Treatment of Veterans With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019 (COVID-19)
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Mayo Clinic
First posted: 2020-09-10
Enrollment: 5044
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

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).

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.

Eligibility criteria: 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, extracorporeal membrane oxygenation (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

Primary outcomes:
measure: All-cause Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Nicholas L. Smith, PhD
role: STUDY_CHAIR
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Michael J Gaziano, MD MPH
role: STUDY_CHAIR
References:
citation: Cho K, Keithly SC, Kurgansky KE, Madenci AL, Gerlovin H, Marucci-Wellman H, Doubleday A, Thomas ER, Park Y, Ho YL, Sugimoto JD, Moore KP, Peterson AC, Hoag C, Gupta K, Jeans K, Klote M, Ramoni R, Huang GD, Casas JP, Gagnon DR, Hernan MA, Smith NL, Gaziano JM. Early Convalescent Plasma Therapy and Mortality Among US Veterans Hospitalized With Nonsevere COVID-19: An Observational Analysis Emulating a Target Trial. J Infect Dis. 2021 Sep 17;224(6):967-975. doi: 10.1093/infdis/jiab330.