Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) Clinical Trial
— CONTACTOfficial title:
EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT
| NCT number | NCT04611230 |
| Other study ID # | H20-308 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 5, 2020 |
| Est. completion date | October 27, 2021 |
| Verified date | October 2022 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1007 |
| Est. completion date | October 27, 2021 |
| Est. primary completion date | October 27, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Great Lakes Clinical Trials /ID# 224874 | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline (Week 0) | |
| Primary | Percentage of Participants With Current SARS-CoV-2 Infection | SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing. | Baseline (Week 0) | |
| Primary | 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. | Up to Approximately 9 months | |
| Secondary | Percentage of Participants With COVID-19 Hospitalization | Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded. | Up to approximately 9 months | |
| Secondary | Percentage of Participants With Influenza and COVID-like Illness | Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness. | Up to approximately 9 months | |
| Secondary | Time to Infection | The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method. | Up to approximately 9 months | |
| Secondary | Time to Symptom Onset | The analysis for overall time to symptom onset will be conducted using the Kaplan-Meier method. | Up to approximately 9 months | |
| Secondary | Time to Symptom Resolution | The analysis for overall time to symptom resolution will be conducted using the Kaplan-Meier method. | Up to approximately 9 months | |
| Secondary | Change in Quality of Life (QOL) | Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L) | Up to approximately 9.5 months |