Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
The purpose of this study is to comprehensively describe the temporal and geographic utilization of COVID-19 therapies used for mild to moderate disease during different periods of SARS-CoV-2 variant circulation as well as to compare demographic and clinical characteristics of Veterans who are treated or do not receive these different therapies. The investigators will also perform similar descriptive epidemiology for other respiratory viruses, including RSV and influenza and other infectious diseases. This first phase will critically inform feasibility and direction of the second phase, in which the investigators will use target trial emulation design to study the comparative effectiveness of therapies and vaccines for COVID-19, respiratory viruses, including RSV, and influenza, and other infectious diseases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All Veterans alive and in Veterans Health Administration (VHA) care as of January 2018
Specific exclusion/inclusion criteria and observation periods will be further defined for each sub-study (See outcomes/publications)
Disqualifiers
VA employees who are not enrollees
Trial population
VA enrollees infected from January 1, 2022 through February 28, 2022 as an example. Subsequent trials will be executed as the pandemic evolves
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
400,000 Participants
are grouped into 4 trial groupsGroup A: Outpatient Veterans with risk factors for severe COVID-19 & tested positive during Jan-Feb 2022
Group B: Nonhospitalized Veterans in VHA at risk for SARS-CoV-2 Jan-Jul 2022
Group C: Outpatient Veterans who tested positive for SARS-CoV-2 from Jan 2022 through Jan 2023
Group D: Outpatient Veterans with risk factors for severe COVID-19 & tested positive during Jan-Jul 2022
Trial outcomes
Primary outcomes
1
Receipt of any COVID-19 pharmacotherapy, including sotrovimab, nirmatrelvir boosted with ritonavir, molnupiravir, or remdesivir
The odds of receipt of any COVID-19 pharmacotherapy, including sotrovimab, nirmatrelvir boosted with ritonavir, molnupiravir, or remdesivir were estimated using multivariable logistic regression
Time frame
January and February 20222
Incidence of any hospitalization or all-cause mortality at 30 days and from 31 to 180 days
Three retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir- ritonavir versus molnupiravir.
Time frame
January through July 20223
Monthly receipt of any COVID-19 pharmacotherapy (nirmatrelvir-ritonavir, molnupiravir, sotrovimab, or bebtelovimab)
To analyze trends and factors associated with prescription of outpatient COVID-19 pharmacotherapies within the Veterans Health Administration (VHA).
Time frame
January 2022 through January 20234
Cumulative incidence of 31 potential PCCs at 31 -180 days after treatment or a matched index date, including cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, endocrine, and general conditions
Retrospective target trial emulation study comparing matched cohorts receiving nirmatrelvir-ritonavir versus no treatment.
Time frame
January through July 2022Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov