Transmissibility and Viral Load of SARS-CoV-2 in Oral Secretions
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|ClinicalTrials.gov Identifier: NCT04348240|
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : July 16, 2020
COVID-19 is a worldwide pandemic and currently there is no effective therapy or vaccine. SARS-CoV-2, the virus that causes the COVID-19 respiratory infection, appears to be very contagious however all the modes of transmission are unclear. Transmission may occur in up to 25 percent of cases when there are no symptoms (asymptomatic). Before there are any symptoms, droplet spray during speaking may increase transmission from person to person; most of the spray is saliva. Researchers at the NIH would like to test saliva for the virus before symptoms are reported. Additionally, they would like to examine the importance of using masks to prevent transmission. They hope to better understand how COVID-19 is spread among people and how it can be prevented.
To determine if the SARS-CoV-2 virus is present in saliva in asymptomatic individuals who are COVID-19 positive.
To determine if using masks can prevent transmission.
People ages 18 and older without symptoms of COVID-19 who have been in close contact (e.g. live in the same house) with someone who has tested positive for COVID-19 or NIH workers who have tested positive for COVID-19 and have mild or no symptoms. Retested individuals may be enrolled to understand how the disease has progressed and resolved.
Design and Procedures:
For screening, interested participants will contact a study team member. The interested participant will be asked to provide documentation of COVID-19 positive status, their symptoms, or their contact to a COVID-19 positive person.
Participants will have weekly telephone calls to discuss their symptoms and 2-5 drive-up visits to the NIH within 28 days.
At the drive-up facility, participants will participate in a speaking exercise with and without wearing a mask. The droplets they produce while they speak will be collected. Participants will spit into a cup and have saliva collected from different areas of the mouth. They should not eat 90 minutes before this but drinking water or juice is acceptable. They may have their tongue painted with a sour liquid to increase their saliva. Participants will have a swab rubbed inside their nose. For those who are close contacts and need a COVID-19 test, they will have a swab inserted through the nose to rub the back of their throat.
Participants will complete questionnaires about their symptoms electronically at home.
Subjects may be asked to return to the NIH more frequently by the study team based on testing results.
If at any time the participants start to have moderate or severe respiratory symptoms, their participation will end and they should seek care with their local provider.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Transmissibility and Viral Load of SARS-CoV-2 Through Oral Secretions|
|Actual Study Start Date :||April 16, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
asymptomatic high-risk subjects with known history of close personal contact with a COVID-19 positive person not tested (SARS-CoV2 status unknown)
- To determine SARS-CoV-2 viral load and infectivity in saliva that may contribute to asymptomatic transmission [ Time Frame: Ongoing ]Detection of virus in saliva
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348240
|Contact: Eileen M Pelayo||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Blake M Warner, D.D.S.||National Institute of Dental and Craniofacial Research (NIDCR)|