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COVID-19 Pandemic Response Network

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320862
Recruitment Status : Active, not recruiting
First Posted : March 25, 2020
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date March 23, 2020
First Posted Date March 25, 2020
Last Update Posted Date May 17, 2021
Actual Study Start Date April 3, 2020
Estimated Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2020)
Number of participants who experience inpatient admission [ Time Frame: 2 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 23, 2020)
  • Number of participants admitted to the intensive care unit [ Time Frame: 2 months ]
  • Number of participants requiring mechanical ventilation [ Time Frame: 2 months ]
  • Number of deceased participants [ Time Frame: 2 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Pandemic Response Network
Official Title Pandemic Response Network: Duke Community Health Watch
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals in the Duke Health region as well as individuals beyond the Duke Health region
Condition
  • COVID-19
  • SARS-CoV-2
  • Coronavirus
  • Influenza -Like Illness
  • Lower Resp Tract Infection
  • Upper Resp Tract Infection
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 13, 2021)
9207
Original Estimated Enrollment
 (submitted: March 23, 2020)
20000
Estimated Study Completion Date June 28, 2021
Estimated Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04320862
Other Study ID Numbers Pro00105189
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Becky Smith, MD Duke University
PRS Account Duke University
Verification Date May 2021