NCT04864548

COV-CHIM01: SARS-CoV-2 (COVID-19) Dose Finding Infection Study

A Dose Finding Human Experimental Infection Study With SARS-CoV-2 in Healthy Volunteers With Immunologically Sensitised With Either Previous, SARS-CoV-2 Infection and/or Vaccination Against SARS-CoV2

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

A phase I, experimental dose finding, open label, clinical infection, safety and viral detection optimisation in previously SARS-CoV-2 infected (unvaccinated or vaccinated) or uninfected vaccinated volunteers.

Detailed description

This is a phase I dose escalation challenge study in which increasing titres of wild-type SARS-CoV-2 (1x10\^1 TCID\_50, 1x10\^2TCID\_50, 1x10\^3TCID\_50, 1x10\^4TCID\_50 and 1x10\^5TCID\_50) will be administered intranasally to different groups of volunteers in order to achieve a 50% (+/-10%) attack rate as determined by quantitative live viral detection and/or qPCR detection in naso-pharyngeal secretions at two consecutive 12 hourly time points (at least 24 hours after inoculation). Dose escalation will be capped at 10\^5 TCID50 and we will proceed to dose confirmation, following DSMB safety review, even if we do not meet our target attack rate of 50% +/- 10%, to enable a larger sample size to assess the dynamic range of protection at that dose and ensure confidence in the negative infection rate at that dose. A Data Safety Monitoring Board (DSMB) will review safety and quantitative virology at each dose level and will recommend continuation based on emergent data. Rescue treatment with a single course of oral Paxlovid will commence immediately after any warning symptoms or signs of COVID-19 disease beyond mild disease. Once the optimal dose of wildtype SARS-CoV-2 has been identified for previously infected volunteers and uninfected vaccinated volunteers (dose escalation groups 1 and 3), further challenge infections in groups 2 and 4 may proceed. Volunteers will remain in isolation rooms within the clinical trials unit for a minimum of 14 days post inoculation and until demonstration of the absence of live virus in two sequential samples. All 4 groups will together enrol up to 132 volunteers. This study will be funded by the Wellcome Trust and Department of Health and Social Care (DHSC).

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 virus	The SARS-COV-2 challenge virus strain was originally obtained from a nose/throat swab taken from a patient who developed respiratory symptoms consistent with COVID-19. The isolate was plaque purified to obtain a 'single' virus entity. The selected plaque, B1, was subsequently manufactured in accordance with GMP at the Great Ormond Street manufacturing suite.

Timeline

• Start date: 2021-05-27
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-04-29
• Last updated: 2023-01-06

Locations

3 sites across 1 country: United Kingdom