COVICI-SURV: COVID-19 Vaccination Around ICI Start and Survival
NCT07729241 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 95015
Last updated 2026-07-27
Summary
COVICI-SURV is a nationwide, retrospective observational cohort study using the French national health data system (SNDS) to evaluate whether COVID-19 vaccination, particularly mRNA vaccination, received within 100 days before or after immune checkpoint inhibitor (ICI) initiation is associated with survival among adults with cancer. The cohort includes 95,015 adults initiating anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy between 28 December 2020 and 22 March 2023. Pre-ICI vaccination is analysed using inverse probability of treatment weighting, and post-ICI vaccination among patients without COVID-19 vaccination in the preceding 100 days is analysed using a cloning-censoring-weighting target-trial emulation. The primary outcome is all-cause mortality; secondary outcomes include cancer-specific mortality, non-COVID-19 mortality and real-world progression-free survival. Follow-up extends to 31 December 2024 for all-cause mortality and to 31 December 2023 for cause-specific mortality.
Conditions
- Cancer
- Immune Checkpoint Inhibitors
- COVID-19 Vaccination
- Survival
Sponsors & Collaborators
-
APHP
collaborator OTHER -
Sorbonne University
collaborator OTHER -
Institut National de la Santé Et de la Recherche Médicale, France
collaborator OTHER_GOV -
Groupe Hospitalier Pitie-Salpetriere
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-28
- Primary Completion
- 2024-12-31
- Completion
- 2026-08-01
Countries
- France
Study Locations
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