Clinical trial NCT04611230: 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
Official title: EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)
Keywords: Severe acute respiratory syndrome - coronavirus 2
SARS-CoV-2
Coronavirus disease 2019
COVID-19
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-11-02
Enrollment: 1007
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers living or employed in Lake County, Illinois.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With Current SARS-CoV-2 Infection
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With Incidence of SARS-CoV-2 Infection
timeFrame: Up to Approximately 9 months
Secondary outcomes:
measure: Percentage of Participants With COVID-19 Hospitalization
timeFrame: Up to approximately 9 months
measure: Percentage of Participants With Influenza and COVID-like Illness
timeFrame: Up to approximately 9 months
measure: Time to Infection
timeFrame: Up to approximately 9 months
measure: Time to Symptom Onset
timeFrame: Up to approximately 9 months
measure: Time to Symptom Resolution
timeFrame: Up to approximately 9 months
measure: Change in Quality of Life (QOL)
timeFrame: Up to approximately 9.5 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 224874
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Kilpatrick 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.