COVID-19NCT04383444
Surveillance of Individuals Following SARS-CoV-2 Infection
An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: People who have had contact with a person with a known SARS-CoV-2 infection are being told to self-quarantine for 14 days. This is done to avoid potential virus spread. But the actual time it takes for a person to develop an infection after being exposed to the virus is not well known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 10 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: NIH staff or contractors working at an NIH facility and able to come to the NIH campus for study visits.
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Able to attent study visits at the NIH.
- Age greater than or equal to 18 years.
- Meets one of the following case definitions:
- Confirmed case: At lease one current or recent (within past 14 days positive RT-PCR test for SARS-CoV-2.
- Probable case: Suspected current or recent (within the past 14 days) SARS-CoV-2 infection by referring physician but no availability of confirmatory test results.
- Able to provide informed consent.
- Willing to allow storage of samples for future research..
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- The most recent RT-PCR tests have yielded two negatives.
- Inability or unwillingness to have NP sampling, mid-turbinate, or saliva sampling
- Inability or unwillingness to have blood sampling.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
People who have had contact with a person with a known SARS-CoV-2 infection are being told to self-quarantine for 14 days. This is done to avoid potential virus spread. But the actual time it takes for a person to develop an infection after being exposed to the virus is not well known. The proper quarantine time could be less or more than 2 weeks. Researchers hope this study can be used to help improve public health guidelines for quarantines, social distancing, and returning to work after a possible SARS-CoV-2 exposure.
Read more
Objective:
To better understand how long it takes a person to develop (or not develop) an infection with the SARS-CoV-2 virus after they have had contact with a person who has a confirmed infection.
Eligibility:
NIH staff members age 18 and older who had recent contact with a person who has a SARS-CoV-2 infection
Design:
Participants will have 3 study visits at the NIH Clinical Center. They may be asked to have an extra visit depending on the test results at the third visit.
At each visit, participants will give a blood and saliva sample. It will be used to test for SARS-CoV-2 antibodies. Their temperature will be taken. They will complete a short survey to collect data about possible COVID-19 symptoms. At the first visit only, they will also complete a survey that asks about their recent social contacts.
Two types of nasal samples will be collected at each visit. These samples will be tested for the SARS-CoV-2 virus.
- a swab will be inserted deep into the back of the nose and
- a swab will be inserted to the middle of your nose.
Participation lasts 3 to 4 weeks.
Read the detailed description
Study Description:
This is a prospective longitudinal cohort study of individuals who have recently tested positive or are highly suspected to be positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV- 2) infection. The aim is to correlate results of reverse transcription-polymerase chain reaction (RT-PCR) using various sample types, assays, and culture. We will enroll individuals with at least one recent positive RT-PCR test result (confirmed cases) and individuals whose referring physician highly suspects current or recent SARS-CoV-2 infection but the individual has not had access to testing (probable cases). At baseline, participants will undergo collection of nasopharyngeal (NP) swabs, saliva samples, and midturbinate swabs for SARS-CoV-2 RT-PCR and culture, and blood draw for antibody assay. Subjects enrolled as probable cases who have a positive baseline RT-PCR result and all subjects enrolled as confirmed cases (regardless of baseline result) will be followed with serial screenings until they have 2 consecutive negative RT-PCR test results.
Objectives:
Primary Objective:
Correlate results of SARS-CoV-2 RT-PCR using various sample types, antibody assays and culture.
Secondary Objectives:
- Determine rate of culture positivity in individuals who persistently shed virus.
- Correlate symptoms with culture positivity and RT-PCR cycle threshold.
Endpoints: Primary Endpoint: Results of SARS-CoV-2 RT-PCR using NP swab, saliva, and midturbinate swab, antibody assay and culture.
Secondary Endpoint:
- SARS-CoV-2 culture and RT-PCR results.
- Symptom checklist and RT-PCR cycle threshold value.
Study Population:
We will enroll up to 1,000 (accrual ceiling: 1,050) adults who have had one or more positive RT-PCR test result(s) within the last two weeks (confirmed cases) and those who have not been tested within the last two weeks but meet a high index of clinical suspicion for current or recent SARS-CoV-2 infection (probable cases).
Facilities Enrolling Participants:
NIH CC.
Study Duration: 3 years.
Participant Duration:
Probable cases who have negative RT-PCR results at baseline will have a single (baseline) visit. Probable cases with positive baseline RT-PCR and all confirmed cases will continue in the
- Conditions
- COVID-19
- Keywords
- COVID-19, Coronavirus, Antibody Testing, Severe Acute Respiratory Syndrome-Coronavirus-2 infection, Natural History
- 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 |
|---|---|---|
| SARS-CoV-2 exposure | NIH staff exposed to SARS-CoV-2 or current or previous SARS-CoV-2 infection, but currently asymptomatic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of SARS-CoV-2 RT- PCR testing, antibody assay, and culture
Correlate results of SARS-CoV-2 RT-PCR using various sample types, antibody assays, and culture.
Measured: Days 1, 14, then every 2-4 weeks as needed
Secondary outcomes (2)
SARS-CoV-2 culture and RT-PCR results
Determine rate of culture positivity in individuals who persistently shed virus.
Measured: Days 1, 14, then ever 2-4 weeks as needed
Symptom checklist and RT-PCR cycle threshold
Correlate symptoms with culture positivity and RT-PCR cycle threshold.
Measured: Days 1, 14, then every 2-4 weeks as applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start7 Jul 2020
- Primary completion1 Mar 2021
- Study completion10 Feb 2022
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven M Holland, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383444
- Sponsor's protocol ID
- 200117
- Other IDs
- 20-I-0117
- Status last verified
- Oct 2023
- First submitted
- 9 May 2020
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Individuals Following SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04383444
- Acronym / sponsor ID
- 200117
- Conditions
- COVID-19
- Keywords
- COVID-19, Coronavirus, Antibody Testing, Severe Acute Respiratory Syndrome-Coronavirus-2 infection, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 12 May 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:
People who have had contact with a person with a known SARS-CoV-2 infection are being told to self-quarantine for 14 days. This is done to avoid potential virus spread. But the actual time it takes for a person to develop an infection after being exposed to the virus is not well known. The proper quarantine time could be less or more than 2 weeks. Researchers hope this study can be used to help improve public health guidelines for quarantines, social distancing, and returning to work after a possible SARS-CoV-2 exposure.
Objective:
To better understand how long it takes a person to develop (or not develop) an infection with the SARS-CoV-2 virus after they have had contact with a person who has a confirmed infection.
Eligibility:
NIH staff members age 18 and older who had recent contact with a person who has a SARS-CoV-2 infection
Design:
Participants will have 3 study visits at the NIH Clinical Center. They may be asked to have an extra visit depending on the test results at the third visit.
At each visit, participants will give a blood and saliva sample. It will be used to test for SARS-CoV-2 antibodies. Their temperature will be taken. They will complete a short survey to collect data about possible COVID-19 symptoms. At the first visit only, they will also complete a survey that asks about their recent social contacts.
Two types of nasal samples will be collected at each visit. These samples will be tested for the SARS-CoV-2 virus.
- a swab will be inserted deep into the back of the nose and
- a swab will be inserted to the middle of your nose.
Participation lasts 3 to 4 weeks.
Detailed description
Study Description:
This is a prospective longitudinal cohort study of individuals who have recently tested positive or are highly suspected to be positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV- 2) infection. The aim is to correlate results of reverse transcription-polymerase chain reaction (RT-PCR) using various sample types, assays, and culture. We will enroll individuals with at least one recent positive RT-PCR test result (confirmed cases) and individuals whose referring physician highly suspects current or recent SARS-CoV-2 infection but the individual has not had access to testing (probable cases). At baseline, participants will undergo collection of nasopharyngeal (NP) swabs, saliva samples, and midturbinate swabs for SARS-CoV-2 RT-PCR and culture, and blood draw for antibody assay. Subjects enrolled as probable cases who have a positive baseline RT-PCR result and all subjects enrolled as confirmed cases (regardless of baseline result) will be followed with serial screenings until they have 2 consecutive negative RT-PCR test results.
Objectives:
Primary Objective:
Correlate results of SARS-CoV-2 RT-PCR using various sample types, antibody assays and culture.
Secondary Objectives:
- Determine rate of culture positivity in individuals who persistently shed virus.
- Correlate symptoms with culture positivity and RT-PCR cycle threshold.
Endpoints: Primary Endpoint: Results of SARS-CoV-2 RT-PCR using NP swab, saliva, and midturbinate swab, antibody assay and culture.
Secondary Endpoint:
- SARS-CoV-2 culture and RT-PCR results.
- Symptom checklist and RT-PCR cycle threshold value.
Study Population:
We will enroll up to 1,000 (accrual ceiling: 1,050) adults who have had one or more positive RT-PCR test result(s) within the last two weeks (confirmed cases) and those who have not been tested within the last two weeks but meet a high index of clinical suspicion for current or recent SARS-CoV-2 infection (probable cases).
Facilities Enrolling Participants:
NIH CC.
Study Duration: 3 years.
Participant Duration:
Probable cases who have negative RT-PCR results at baseline will have a single (baseline) visit. Probable cases with positive baseline RT-PCR and all confirmed cases will continue in the
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 exposure | – | –NIH staff exposed to SARS-CoV-2 or current or previous SARS-CoV-2 infection, but currently asymptomatic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NIH staff or contractors working at an NIH facility and able to come to the NIH campus for study visits.
Key inclusion criteria (8 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Able to attent study visits at the NIH.
- Age greater than or equal to 18 years.
- Meets one of the following case definitions:
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- The most recent RT-PCR tests have yielded two negatives.
- Inability or unwillingness to have NP sampling, mid-turbinate, or saliva sampling
- Inability or unwillingness to have blood sampling.
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
Results of SARS-CoV-2 RT- PCR testing, antibody assay, and culture
Time frame: Days 1, 14, then every 2-4 weeks as needed
Correlate results of SARS-CoV-2 RT-PCR using various sample types, antibody assays, and culture.
2 secondary outcomes
SARS-CoV-2 culture and RT-PCR results
Time frame: Days 1, 14, then ever 2-4 weeks as needed
Symptom checklist and RT-PCR cycle threshold
Time frame: Days 1, 14, then every 2-4 weeks as applicable
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 1 Nov 2023.
- 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.
Steven M Holland, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site 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 Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 8 inclusion and 4 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results of SARS-CoV-2 RT- PCR testing, antibody assay, and culture (time frame: Days 1, 14, then every 2-4 weeks as needed). 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 1 Nov 2023.