COVID-19 Community Research Partnership
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04342884 |
|
Recruitment Status :
Recruiting
First Posted : April 13, 2020
Last Update Posted : May 27, 2022
|
Sponsor:
Wake Forest University Health Sciences
Collaborators:
Centers for Disease Control and Prevention
North Carolina Department of Health and Human Services
Information provided by (Responsible Party):
Wake Forest University Health Sciences
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this research is to collect information about the North Carolina community's coronavirus exposures, symptoms, and health care visits due to the virus. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.
| Condition or disease |
|---|
| Coronavirus COVID |
Investigators will conduct a prospective, cohort study for SARS-CoV-2 infections among clients and health care workers of Wake Forest Baptist Health (WFBH). Investigators will conduct real-time syndromic respiratory disease surveillance and, for SARS-CoV-2 infections, calculate baseline seroprevalence and seroconversion rates, hazard risks from close contacts, estimate efficacy of personal protective equipment, and assess sequelae incidence. Investigators will utilize the COVID-19 Therapeutic Learning System, an Oracle developed self-reporting data collection system that can be easily modified to address these specific questions. Over the course of the study, volunteers will report daily exposures, risk reduction behaviors, and symptoms through a secure app on their smartphone, tablet, or computer. In addition to daily syndromic surveillance, at baseline and once every month after that we will use a serologic IgM/G test kit to identify infections and reinfections in volunteers and send results to the Oracle developed database. The areas covered by this study are experiencing community spread of COVID-19 but are early enough in the epidemic to capture potentially a significant number of seroconversions over the 12 months of the study. This surveillance model will be expanded to include the clients and health workers of other medical agencies in North Carolina and in other states.
| Study Type : | Observational |
| Estimated Enrollment : | 150000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records |
| Actual Study Start Date : | April 8, 2020 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | March 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Group/Cohort |
|---|
| Clients of Wake Forest Baptist Health (WFBH) |
| Health care workers of Wake Forest Baptist Health (WFBH) |
Primary Outcome Measures :
- Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina [ Time Frame: baseline ]Percent of volunteers who are 2019-nCoV Ab test positive
- Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina [ Time Frame: baseline ]Percent of volunteers who are 2019-nCoV Ab test positive
Secondary Outcome Measures :
- Cumulative incidence of SARS-CoV-2 infection [ Time Frame: 12 month ]
- Monthly incidence of SARS-CoV-2 infection [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 infection by age group [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 infection by sex [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 by season [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 infection by geographic area (zip code) [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts [ Time Frame: Month 1 thru month 12 ]
- Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by age group [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by sex [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by season [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by geographic area (zip code) [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by preexisting comorbidities [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by COVID-2 contacts [ Time Frame: Month 1 thru month 12 ]
- Relative risk of SARS-CoV-2 infection by use of PPE by health workers [ Time Frame: Month 1 thru month 12 ]
- Incidence of sequelae [ Time Frame: Month 1 thru month 12 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Investigators will seek enrollment of the clients and health care workers from diverse hospitals and clinics of WFBH.
Criteria
Inclusion Criteria:
- All clients and health care worker of WFBH are eligible for enrollment.
Exclusion Criteria:
- Health care workers who do not receive medical services through WFBH will not be enrolled.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342884
Contacts
| Contact: Wake Forest Baptist Medical Center | 336-70-COVID | jwsander@wakehealth.edu |
Locations
| United States, Louisiana | |
| Tulane University School of Public Health and Tropical Medicine | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of Maryland School of Medicine | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Medstar Health | Recruiting |
| Columbia, Maryland, United States, 21044 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| United States, North Carolina | |
| Atrium Health | Recruiting |
| Charlotte, North Carolina, United States, 28202 | |
| Vidant Health | Recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Campbell University School of Osteopathic Medicine | Recruiting |
| Lillington, North Carolina, United States, 27546 | |
| New Hanover Regional Medical Center | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| Wake Forest Baptist Health | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Wake Forest Baptist Medical Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| WakeMed Health and Hospitals | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
Sponsors and Collaborators
Wake Forest University Health Sciences
Centers for Disease Control and Prevention
North Carolina Department of Health and Human Services
Investigators
| Principal Investigator: | John W Sanders, MD, MPH&TM | Wake Forest University Health Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT04342884 |
| Obsolete Identifiers: | NCT04361123 |
| Other Study ID Numbers: |
IRB00064912 FP00000129 ( Other Grant/Funding Number: North Carolina Department of Health and Human Services ) SC-75D30120C08405 ( Other Identifier: Centers for Disease Control and Prevention ) |
| First Posted: | April 13, 2020 Key Record Dates |
| Last Update Posted: | May 27, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Wake Forest University Health Sciences:
|
COVID-19 |
Additional relevant MeSH terms:
|
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |