Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04740320
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
COVID-19 SARS-CoV-2 Screening Protocol
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
Screening Protocol for a Dose Finding Human Experimental Infection Study in Healthy Subjects Using a GMP-produced SARS-COV-2 Wild Type Strain
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The aim of this screening protocol is to assess volunteers for their potential eligibility to participate in a dose finding human experimental infection study in healthy subjects using a GMP-produced SARS-CoV-2 wild type strain
Detailed Description:
Recruitment will be done through a number of channels:
* Approved advertising, including social medial
* hVIVO volunteer database
* Referral
* Organic search, i.e. where the volunteer has learned of this study by doing a Google search or through friends or family rather than due to any advertising Following Research Ethics Committee approval of the full study, screened subjects who confirm their willingness to participate in the SARS-CoV-2 human infection challenge characterization study will be invited to consider the study-specific PIS-ICF and enter the final study consenting process.
The number of subjects who are to be recruited will depend on specific sample-size requirements for the SARS-CoV-2 human infection characterization study.
* Approved advertising, including social medial
* hVIVO volunteer database
* Referral
* Organic search, i.e. where the volunteer has learned of this study by doing a Google search or through friends or family rather than due to any advertising Following Research Ethics Committee approval of the full study, screened subjects who confirm their willingness to participate in the SARS-CoV-2 human infection challenge characterization study will be invited to consider the study-specific PIS-ICF and enter the final study consenting process.
The number of subjects who are to be recruited will depend on specific sample-size requirements for the SARS-CoV-2 human infection characterization study.
Study Oversight
Has Oversight DMC:
False
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?: