COVID-19 Tests With Saliva Specimens

Covid19 Clinical Trial

Official title:

COVID-19 Tests With Saliva Specimens

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04567953
• Other study ID #: PLRD202001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: June 27, 2021

Study information

• Verified date: September 2020
• Source: Paradigm Laboratories LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: June 27, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and

• Is able to give informed consent

• Is able to understand oral or written instructions, and

• Is able to mentally and physically perform self-collection of saliva using the provided collection device.

Exclusion Criteria:

• - Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Employees of Paradigm lab and the assisted living facilities involved in the study

• Members of other vulnerable populations

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Saliva collection
Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva

Locations

Country	Name	City	State
United States	Paradigm Laboratories	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Paradigm Laboratories LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical evaluation of saliva as specimen for COVID-19 molecular test	We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.	1 hour