Collection of Clinical Specimens From Volunteers for Assay Development

Completed

• Conditions: Acute Respiratory Infection

• Registration Number: NCT03606382
• Lead Sponsor: Inflammatix

Brief Summary

This study will analyze gene expression data from various biological specimens collected from voluntary participants.

Detailed Description

Primary objective is the collection of specimens from volunteers for the development and validation of HostDx tests. The study does only encompass specimen collection - Therefore, no traditional endpoint is defined but rather the successful collection of clinical specimens is defined as the endpoint.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-07-30
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 18 years of age or greater
• Able to provide informed consent

Exclusion Criteria

• Known pregnancy
• Inability to understand instructions and comply with study related procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests	1 Day	Blood collection, upper respiratory specimens including. nasal swabs, nasal washes, nasopharyngeal swabs, buccal swabs, buccal washes), sputum, saliva, urine and a skin/soft-tissue specimen (dermal).

Trial Locations

Locations (1)

Inflammatix, Inc.; 🇺🇸 Burlingame, California, United States