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Completed

NCT Number: 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

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.

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Key information

Conditions

Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Lakes Clinical Trials /ID# 224874

Chicago, Illinois, 60640, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Percentage of Participants With COVID-19 Hospitalization

    Time frame: Up to approximately 9 months

    Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded.

  2. Percentage of Participants With Influenza and COVID-like Illness

    Time frame: Up to approximately 9 months

    Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.

  3. Time to Infection

    Time frame: Up to approximately 9 months

    The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.

  4. Time to Symptom Onset

    Time frame: Up to approximately 9 months

    The analysis for overall time to symptom onset will be conducted using the Kaplan-Meier method.

  5. Time to Symptom Resolution

    Time frame: Up to approximately 9 months

    The analysis for overall time to symptom resolution will be conducted using the Kaplan-Meier method.

  6. Change in Quality of Life (QOL)

    Time frame: Up to approximately 9.5 months

    Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L)

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT

Acronym: CONTACT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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