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COVID-19 Pandemic Response Network

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ClinicalTrials.gov Identifier: NCT04320862
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives.

  • First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll.
  • Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation.
  • Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population.

The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).


Condition or disease
COVID-19 SARS-CoV-2 Coronavirus Influenza -Like Illness Lower Resp Tract Infection Upper Resp Tract Infection

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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pandemic Response Network: Duke Community Health Watch
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
Duke Health region and beyond
Individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19.



Primary Outcome Measures :
  1. Number of participants who experience inpatient admission [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Number of participants admitted to the intensive care unit [ Time Frame: 2 months ]
  2. Number of participants requiring mechanical ventilation [ Time Frame: 2 months ]
  3. Number of deceased participants [ Time Frame: 2 months ]


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals in the Duke Health region as well as individuals beyond the Duke Health region
Criteria

Inclusion Criteria:

  • flu-like symptoms
  • a viral test order for COVID-19
  • confirmed COVID-19
  • concern for exposure to COVID-19

Exclusion Criteria:

- None


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): NCT04320862


Contacts
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Contact: Mark Sendak, MD, MPP 919-684-3234 mark.sendak@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27713
Sub-Investigator: Raquel Bartz, M.D.         
Sub-Investigator: Manesh Patel, M.D.         
Sub-Investigator: Devdutta Sangvai, M.D.         
Sub-Investigator: Mark Sendak, M.D.         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Becky Smith, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04320862    
Other Study ID Numbers: Pro00105189
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases