NCT04865237

SARS-CoV-2 Human Challenge Characterisation Study

A Dose Finding Human Experimental Infection Study in Healthy Subjects Using a GMP-produced SARS-COV-2 Wild Type Strain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This is a dose optimisation study in healthy adults aged 18-30 who will be experimentally inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in the majority of challenged individuals with minimal or no illness, providing data on the course of COVID-19 and the immune response to SARS-CoV-2 infection. This will establish an optimised dose and study design that will then be used to evaluate the efficacy of treatment and vaccine candidates plus level and duration of immune protection in follow-on trials.

Conditions

• Covid19
• SARS-CoV Infection
• Corona Virus Infection
• Coronavirus
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Virus 1x10^1 TCID50	SARS-CoV-2, intranasally, (1x10\^1 TCID50)
DRUG	Remdesivir	VEKLURY™
BIOLOGICAL	SARS-CoV-2 Virus 1x10^2 TCID50	SARS-CoV-2, intranasally, (1x10\^2 TCID50)
BIOLOGICAL	SARS-CoV-2 Virus 1x10^3 TCID50	SARS-CoV-2, intranasally, (1x10\^3 TCID50)

Timeline

• Start date: 2021-03-06
• Primary completion: 2022-07-11
• Completion: 2022-07-11
• First posted: 2021-04-29
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

2 sites across 1 country: United Kingdom