Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864548
Status:
RECRUITING
Last Update Posted:
2023-01-06
First Post:
2021-04-20
Brief Title:
COV-CHIM01 SARS-CoV-2 COVID-19 Dose Finding Infection Study
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Dose Finding Human Experimental Infection Study With SARS-CoV-2 in Healthy Volunteers With Immunologically Sensitised With Either Previous SARS-CoV-2 Infection andor Vaccination Against SARS-CoV2
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1x101 TCID_50 1x102TCID_50 1x103TCID_50 1x104TCID_50 and 1x105TCID_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 andor 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 105 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None