COVID-19NCT04424446
Saliva as Source of Detection for SARS-CoV-2
An observational study of COVID-19, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
Background: Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. Researchers want to find an easier way to collect samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 456 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2020to 4 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NIH staff undergoing standard NIH COVID-19 screening
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Is one of the following:
- An NIH staff member participating in NIH CC SARS-CoV-2 surveillance, or
- A WHC patient who had or is having a diagnostic NP RT-PCR test for SARS-CoV-2.
- Age greater than or equal to 18 years.
- Able to provide informed consent.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability or unwillingness to have NP sampling or midturbinate sampling (applies to NIH site only).
- Inability or unwillingness to provide saliva sample (applies to both NIH and WHC sites).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Evaluation of Saliva as Source of Detection for SARS-CoV-2
Background:
Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. Researchers want to find an easier way to collect samples.
Read more
Objective:
To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front part of the nostril only, or a saliva sample plus a nasal swab gives results that are as accurate as the NP swab.
Eligibility:
NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance.
Design:
The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP swab is collected by OMS. If their NP swab was already collected, their OMS record will be reviewed for the result.
If the NP swab result is positive, the participant will have another NP swab. At that time, they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have an NP swab.
For the saliva sample, participants will spit into a tube.
For the nasal swab, the inside of the front part of the nostril will be swabbed.
Participation ends after the study samples are collected. Participants can choose to keep giving saliva and nasal swab samples each time they have an NP swab.
Read the detailed description
Because of the inconvenience of nasopharyngeal (NP) testing for SARS-CoV-2 detection, we are interested in identifying different strategies for detecting infection. A technique that is less intrusive would put individuals undergoing testing at lower risk for complications, would likely increase compliance with subsequent tests, and would decrease risk to the providers who are conducting the test. For asymptomatic screening, some institutions are using midturbinate swabs instead of NP swabs, for increased compliance due to decreased discomfort. The NIH has switched to midturbinate collection in asymptomatic collections only. A test that would require only expectorating saliva and/or collection of a midturbinate swab would address the issues of NP collection discomfort. Saliva is the most preferred by patients or asymptomatic staff due to no collection in the nasal cavity at all. Although the CDC lists midturbinate swab as an acceptable specimen type, there are minimal data about the sensitivity of this collection for SARS-CoV-2, and decisions to use midturbinate swabs are based in part on experience with other respiratory viruses. Also, if saliva were found to be equivalent to NP for patient testing, there will be a benefit to future patients in providing this option for testing. Therefore, we propose to validate these sample types for SARS-CoV-2 detection. The RT-PCR results based on a saliva sample alone or a saliva sample coupled with a midturbinate swab, will be correlated with the results using surveillance or diagnostic swab samples to validate their use for SARS-CoV-2 detection.
- Conditions
- COVID-19
- Keywords
- Coronavirus, COVID-19, SARS-CoV-2 RT-PCR, Severe Acute Respiratory Syndrome Coronavirus 2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NIH staff | NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva SARS-CoV-2 RT-PCR test results
Validate saliva or nasal swab as a source of detection for SARS-CoV-2.
Measured: Screening
Secondary outcomes (1)
Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results
Validate saliva coupled with a nasal swab as a source of detection for SARS-CoV-2.
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start13 Jul 2020
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karen M Frank, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424446
- Sponsor's protocol ID
- 200128
- Other IDs
- 20-CC-0128
- Status last verified
- May 2021
- First submitted
- 9 Jun 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Saliva as Source of Detection for SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04424446
- Acronym / sponsor ID
- 200128
- Conditions
- COVID-19
- Keywords
- Coronavirus, COVID-19, SARS-CoV-2 RT-PCR, Severe Acute Respiratory Syndrome Coronavirus 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. Researchers want to find an easier way to collect samples.
Objective:
To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front part of the nostril only, or a saliva sample plus a nasal swab gives results that are as accurate as the NP swab.
Eligibility:
NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance.
Design:
The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP swab is collected by OMS. If their NP swab was already collected, their OMS record will be reviewed for the result.
If the NP swab result is positive, the participant will have another NP swab. At that time, they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have an NP swab.
For the saliva sample, participants will spit into a tube.
For the nasal swab, the inside of the front part of the nostril will be swabbed.
Participation ends after the study samples are collected. Participants can choose to keep giving saliva and nasal swab samples each time they have an NP swab.
Detailed description
Because of the inconvenience of nasopharyngeal (NP) testing for SARS-CoV-2 detection, we are interested in identifying different strategies for detecting infection. A technique that is less intrusive would put individuals undergoing testing at lower risk for complications, would likely increase compliance with subsequent tests, and would decrease risk to the providers who are conducting the test. For asymptomatic screening, some institutions are using midturbinate swabs instead of NP swabs, for increased compliance due to decreased discomfort. The NIH has switched to midturbinate collection in asymptomatic collections only. A test that would require only expectorating saliva and/or collection of a midturbinate swab would address the issues of NP collection discomfort. Saliva is the most preferred by patients or asymptomatic staff due to no collection in the nasal cavity at all. Although the CDC lists midturbinate swab as an acceptable specimen type, there are minimal data about the sensitivity of this collection for SARS-CoV-2, and decisions to use midturbinate swabs are based in part on experience with other respiratory viruses. Also, if saliva were found to be equivalent to NP for patient testing, there will be a benefit to future patients in providing this option for testing. Therefore, we propose to validate these sample types for SARS-CoV-2 detection. The RT-PCR results based on a saliva sample alone or a saliva sample coupled with a midturbinate swab, will be correlated with the results using surveillance or diagnostic swab samples to validate their use for SARS-CoV-2 detection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIH staff | – | –NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NIH staff undergoing standard NIH COVID-19 screening
Key inclusion criteria (6 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Is one of the following:
- Age greater than or equal to 18 years.
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability or unwillingness to have NP sampling or midturbinate sampling (applies to NIH site only).
- Inability or unwillingness to provide saliva sample (applies to both NIH and WHC sites).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Saliva SARS-CoV-2 RT-PCR test results
Time frame: Screening
Validate saliva or nasal swab as a source of detection for SARS-CoV-2.
1 secondary outcome
Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results
Time frame: Screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Frank, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva SARS-CoV-2 RT-PCR test results (time frame: Screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.