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Clinical Trial Summary

A phase I, experimental dose finding, open label, clinical infection, safety and viral detection optimisation in healthy volunteers aged 18-30, previously infected with SARS-CoV-2.

Clinical Trial 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 and 1x10^3TCID_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). A Data Safety Monitoring Board (DSMB) will review safety and quantitative virology at each dose level and will recommend continuation, dose escalation or de-escalation based on emergent data. Rescue treatment with a single infusion of 1200mg intravenous monoclonal antibody cocktail (REGN-COV2) will commence immediately after symptoms, signs or investigations suggestive of COVID-19. Once the optimal dose of wildtype SARS-CoV-2 has been identified, further challenge infections in group 2 may proceed without REGN-COV2 treatment (following DSMB review of infection rate, viral load and clinical data). 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. Volunteers will be recruited from the Thames Valley region with screening and outpatient follow up visits at the Clinical Centre for Vaccinology and Tropical Medicine. They will be challenged and admitted for a quarantine period within rooms with appropriate ventilation to prevent spread of infection (negative pressure rooms or positive pressure ventilation lobby) located at Oxford University Hospitals NHS trust or Oxford Clinical Research Facility (OxCRF) depending on bed availability. It is planned that a total of up to 64 participants (44 with option of an additional 20) will be enrolled across 2 groups. This study will be funded by the Wellcome Trust. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04864548
Study type Interventional
Source University of Oxford
Contact Volunteer Recruitment Co-ordinator
Phone 07990431010
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date May 2021
Completion date November 2022

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