COVID-19 Pandemic Response Network

NCT04320862 | Completed

• 1 other identifier: Pro00105189
• Study Type: observational
• Target: 9,207
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; SARS-CoV-2; Coronavirus; Influenza -Like Illness; Lower Resp Tract Infection; Upper Resp Tract Infection

Outcome Measures

Primary Outcomes (1)

• Number of participants who experience inpatient admission

  2 months

Secondary Outcomes (3)

• Number of participants admitted to the intensive care unit

  2 months

• Number of participants requiring mechanical ventilation

  2 months

• Number of deceased participants

  2 months

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals in the Duke Health region as well as individuals beyond the Duke Health region

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Becky Smith, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: April 3, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)