Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)CONTACTNCT04611230
A Study to Assess Infection Rate of Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) and It's Affect on Quality of Life in Adult Volunteers in Lake County, Illinois
An observational study of Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2), run by AbbVie at 1 site in United States.
Trial summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)
- How many people
- 1,007 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 27 Oct 2021
- 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: Adult volunteers living or employed in Lake County, Illinois.
Who may be able to join
- Currently living or employed in Lake County, Illinois.
- Have regular access to computer, smartphone or tablet and sufficient internet access to connect to study platform.
- Willing and able to provide informed consent for collection of online data and of respiratory and blood specimens.
- Willing and able to follow the procedures of the study.
- Able to complete survey in English or Spanish.
Who cannot join
- Unable to provide informed consent.
- Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks.
- Hospitalized at the time of study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes Clinical Trials /ID# 224874
Chicago, Illinois, 60640
About this study
Official title: EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois.
Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled.
Read more
Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks.
There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.
- Keywords
- Severe acute respiratory syndrome - coronavirus 2, SARS-CoV-2, Coronavirus disease 2019, COVID-19
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| Adult Volunteers (Low Risk Group) | Volunteers with jobs that do not require close contact with (i.e., within 6 feet of) the general public or co-workers. | |
| Adult Volunteers (Medium - Low Risk Group) | Volunteers with jobs that require in-frequent contact with (i.e., within 6 feet of) the general public or co-workers. | |
| Adult Volunteers (Medium - High Risk Group) | Volunteers with jobs that require frequent contact with (i.e., within 6 feet of) the general public or co-workers. | |
| Adult Volunteers (High Risk Group) | Volunteers with jobs that require frequent and/or close contact with (i.e., within 6 feet of) individuals with high potential for exposure to known or suspected sources of COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
SARS-CoV-2 infection prior to enrollment is assessed by Immunoglobulin G (IgG) serology testing and/or self-reported diagnosis.
Measured: Baseline (Week 0)
Percentage of Participants With Current SARS-CoV-2 Infection
SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing.
Measured: Baseline (Week 0)
Percentage of Participants With Incidence of SARS-CoV-2 Infection
Incidence of SARS-CoV-2 Infection is assessed by positive PCR test, positive IgG serology test or COVID-19 diagnosis.
Measured: Up to Approximately 9 months
Secondary outcomes (6)
Percentage of Participants With COVID-19 Hospitalization
Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded.
Measured: Up to approximately 9 months
Percentage of Participants With Influenza and COVID-like Illness
Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.
Measured: Up to approximately 9 months
Time to Infection
The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.
Measured: Up to approximately 9 months
Time to Symptom Onset
The analysis for overall time to symptom onset will be conducted using the Kaplan-Meier method.
Measured: Up to approximately 9 months
Time to Symptom Resolution
The analysis for overall time to symptom resolution will be conducted using the Kaplan-Meier method.
Measured: Up to approximately 9 months
Change in Quality of Life (QOL)
Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L)
Measured: Up to approximately 9.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start5 Nov 2020
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611230
- Sponsor's protocol ID
- H20-308
- Acronym
- CONTACT
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2020
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanchez-Solino O, Kilpatrick RD, Johnson C, Fang Y, Ye Y, Alami NN, Zarish K, Krueger WS, Dreyer N, Gray GC. Longitudinal Molecular and Serological Evidence of SARS-CoV-2 Infections and Vaccination Status: Community-Based Surveillance Study (CONTACT). Infect Dis Ther. 2024 Apr;13(4):633-645. doi: 10.1007/s40121-024-00923-4. Epub 2024 Mar 10.
PubMed 38461480Kilpatrick RD, Sanchez-Solino O, Alami NN, Johnson C, Fang Y, Wegrzyn LR, Krueger WS, Ye Y, Dreyer N, Gray GC. EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study. Infect Dis Ther. 2022 Apr;11(2):899-911. doi: 10.1007/s40121-022-00593-0. Epub 2022 Feb 2.
PubMed 35107821
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT
- ClinicalTrials.gov ID
- NCT04611230
- Acronym / sponsor ID
- CONTACT / H20-308
- Keywords
- Severe acute respiratory syndrome - coronavirus 2, SARS-CoV-2, Coronavirus disease 2019, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 2 Nov 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.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois.
Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled.
Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks.
There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult Volunteers (Low Risk Group) | – | –Volunteers with jobs that do not require close contact with (i.e., within 6 feet of) the general public or co-workers. |
| Adult Volunteers (Medium - Low Risk Group) | – | –Volunteers with jobs that require in-frequent contact with (i.e., within 6 feet of) the general public or co-workers. |
| Adult Volunteers (Medium - High Risk Group) | – | –Volunteers with jobs that require frequent contact with (i.e., within 6 feet of) the general public or co-workers. |
| Adult Volunteers (High Risk Group) | – | –Volunteers with jobs that require frequent and/or close contact with (i.e., within 6 feet of) individuals with high potential for exposure to known or suspected sources of COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers living or employed in Lake County, Illinois.
Key inclusion criteria (5 listed)
- Currently living or employed in Lake County, Illinois.
- Have regular access to computer, smartphone or tablet and sufficient internet access to connect to study platform.
- Willing and able to provide informed consent for collection of online data and of respiratory and blood specimens.
- Willing and able to follow the procedures of the study.
- Able to complete survey in English or Spanish.
Key exclusion criteria (3 listed)
- Unable to provide informed consent.
- Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks.
- Hospitalized at the time of study enrollment.
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
Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
Time frame: Baseline (Week 0)
SARS-CoV-2 infection prior to enrollment is assessed by Immunoglobulin G (IgG) serology testing and/or self-reported diagnosis.
Percentage of Participants With Current SARS-CoV-2 Infection
Time frame: Baseline (Week 0)
SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing.
Percentage of Participants With Incidence of SARS-CoV-2 Infection
Time frame: Up to Approximately 9 months
Incidence of SARS-CoV-2 Infection is assessed by positive PCR test, positive IgG serology test or COVID-19 diagnosis.
6 secondary outcomes
Percentage of Participants With COVID-19 Hospitalization
Time frame: Up to approximately 9 months
Percentage of Participants With Influenza and COVID-like Illness
Time frame: Up to approximately 9 months
Time to Infection
Time frame: Up to approximately 9 months
Time to Symptom Onset
Time frame: Up to approximately 9 months
Time to Symptom Resolution
Time frame: Up to approximately 9 months
Change in Quality of Life (QOL)
Time frame: Up to approximately 9.5 months
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 10 Oct 2022.
- Derived from this study: PubMed 38461480Sanchez-Solino O, Kilpatrick RD, Johnson C, Fang Y, Ye Y, Alami NN, Zarish K, Krueger WS, Dreyer N, Gray GC. Longitudinal Molecular and Serological Evidence of SARS-CoV-2 Infections and Vaccination Status: Community-Based Surveillance Study (CONTACT). Infect Dis Ther. 2024 Apr;13(4):633-645. doi: 10.1007/s40121-024-00923-4. Epub 2024 Mar 10.
- Derived from this study: PubMed 35107821Kilpatrick RD, Sanchez-Solino O, Alami NN, Johnson C, Fang Y, Wegrzyn LR, Krueger WS, Ye Y, Dreyer N, Gray GC. EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study. Infect Dis Ther. 2022 Apr;11(2):899-911. doi: 10.1007/s40121-022-00593-0. Epub 2022 Feb 2.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
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 Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2), run by AbbVie 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 5 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 10 Oct 2022. 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?
Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection (time frame: Baseline (Week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611230, which also lists 2 linked publications.
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 10 Oct 2022.