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SARS-CoV-2 Human Challenge Characterisation Study

NCT04865237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-16

Study results available
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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

Interventions

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)

Sponsors & Collaborators

  • Hvivo

    collaborator INDUSTRY

  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Christopher Chiu · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-06
Primary Completion
2022-07-11
Completion
2022-07-11

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865237 on ClinicalTrials.gov