Clinical Trial

COVICI-SURV: COVID-19 Vaccination Around ICI Start and Survival

Study acronym: COVICI-SURV
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07729241
Lead Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators: APHP, Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France
Conditions Cancer, Immune Checkpoint Inhibitors, COVID-19 Vaccination, Survival
Enrollment 95,015 participants
Start Date 2020-12-28
Primary Completion 2024-12-31 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-27