COVID-19 Pandemic Response Network

COVID-19 Clinical Trial

Official title:

Pandemic Response Network: Duke Community Health Watch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320862
• Other study ID #: Pro00105189
• Status: Completed
• Start date: April 3, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9207
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• flu-like symptoms

• a viral test order for COVID-19

• confirmed COVID-19

• concern for exposure to COVID-19

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus
• COVID-19
• Infections
• Influenza -Like Illness
• Lower Resp Tract Infection
• SARS-CoV-2
• Upper Resp Tract Infection

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experience inpatient admission		2 months
Secondary	Number of participants admitted to the intensive care unit		2 months
Secondary	Number of participants requiring mechanical ventilation		2 months
Secondary	Number of deceased participants		2 months