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Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants

Study acronym: COVHIC003
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 3 changed
See other at-risk trials from Imperial College London

Record History

  1. Primary endpoint(s) modified Recruitment opened · Trial sites expanded: 0 → 5 locations · Start date changed from estimate of Jun 1, 2026 to Jul 10, 2026 · 1 morev2 Show 4 more changesShow less
    • Recruitment opened
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of Jun 1, 2026 to Jul 10, 2026
    • Collaborators expanded, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
COVHIC003 is a human infection challenge study in which healthy adults aged 18-50 previously vaccinated with an approved COVID-19 vaccine will be administered a SARS-CoV-2 Omicron EG.5.1 variant given by drops in the nose. The aim is to achieve breakthrough upper-respiratory infection in a proportion of volunteers with mild or no illness, providing information on the course of Omicron infection and the immune response in vaccinated people. This study will establish an optimised challenge dose and model that can then be used to evaluate new vaccines and treatments in follow-on trials. Participants will stay in a quarantine unit for approximately 10-12 days, depending on infection status, and will be closely monitored with regular swabs, blood tests and symptom assessments throughout their stay. They will be followed up by the study team for 6 months after being discharged. This study is sponsored by Imperial College London and forms part of the MUSICC project which is led by Imperial College London and co-funded by the European Union's Horizon Europe Programme and the Coalition for Epidemic Preparedness Innovations (CEPI). Quarantine will take place at specialist facilities in Oxford or at the Royal Free Hospital in London.
Trial Details
NCT Number NCT07397455
Lead Sponsor Imperial College London
Collaborators: Imperial College Healthcare NHS Trust, University College, London, University of Oxford, Royal Free Hospital NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Oxford University Hospitals NHS Trust
Conditions SARS-CoV-2 (COVID-19)
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov