NCT04740320

COVID-19 SARS-CoV-2 Screening Protocol

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

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.

Conditions

• Covid19

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-06-23
• Completion: 2021-07-09
• First posted: 2021-02-05
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

1 site across 1 country: United Kingdom