A Prospective "Universal" Observational Database for COVID-19

• ClinicalTrials.gov Identifier: NCT04347993
• Recruitment Status: Active, not recruiting
• First Posted: April 15, 2020
• Last Update Posted: May 12, 2022
• Sponsor: Hackensack Meridian Health
• Information provided by (Responsible Party): Hackensack Meridian Health

Tracking Information

• First Submitted Date: April 13, 2020
• First Posted Date: April 15, 2020
• Last Update Posted Date: May 12, 2022
• Actual Study Start Date: March 27, 2020
• Actual Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2020)

• Need for hospitalization [ Time Frame: 1 Year ]
  Rate of Hospitalization
• Duration of hospitalization [ Time Frame: 1 Year ]
  The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
• Need for ICU/Ventilator Support [ Time Frame: 1 Year ]
  Rate of ICU/Ventilator Support
• Duration of ICU/Ventilator Support [ Time Frame: 1 Year ]
  The duration of ICU/Ventilator Support is defined as the time in days from the first day of using mechanical ventilation/ICU admission to the last day of using mechanical ventilation/ICU discharge. All evaluable patients will be included and no censoring for this analysis.
• Overall Survival [ Time Frame: 1 Year ]
  Overall survival will be defined as the time in days from study entry to death. Patients who are alive on the date of closing follow-up will be censored on that date.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective "Universal" Observational Database for COVID-19
• Official Title: Real World Observational Database for COVID-19 Treatment and Outcomes
• Brief Summary: The Hackensack Meridian Health Universal Observational COVID-19, a descriptive observational database, is a multi-center initiative collecting data throughout the Hackensack Meridian Health Network (HMH). HMH utilizes the EPIC system at most of the facilities, which will serve as the primary data source. The database will be designed within the REDCap system. A de-identified dataset will be sent to COTA for primary statistical analysis as requested by the research teams.

Detailed Description

The principle objective of this observational database is to build research-grade real world data that will serve as platform to advance the scientific understanding and clinical care of patients with COVID-19.

1. Demographic, diagnostic, treatment and outcome data from centers throughout the Hackensack Meridian Health Network will be abstracted from the electronic health records of patients with confirmed or suspected COVID-19. This will be purely observational and no direction as to the care of the patient will be performed as part of this effort.

1a. Data points to be collected will include, but are not limited to: age, gender, zip code, prior evaluation for COVID-19, tobacco history, race, site of care, healthcare worker, nursing home care, visits to ER, presenting features of fever/ cough/ dyspnea/ gastrointestinal/ mental status changes, days of symptoms, comorbidities, uses of antihypertensives, duration of hospitalization/ icu care, presenting laboratory functions, presenting vital signs, need for oxygen support, dialysis/ ecmo use, treatment with hydroxychloroquine/ azithromycin/ remdesevir/ tociluzimab/ anti-inflammatory agents, arrhythmias/ QTc prolongation, enrollment on clinical trial, positive cultures, survival and cause of death. Additional data points will be added as needed.

2. The data will be entered into a central "Universal" database hosted within the REDCap system (HIPAA compliant, secure, access only per HMH research approval)

3. A de-identified dataset will be sent to COTA for primary statistical analysis as requested by the research teams. COTA will also make available a data/analytic visualization tool (hosted on Tableau) for analysis by primary investigators.

4. Additional data points and analysis may be added to the Universal database as requested by HMH investigators with IRB approval. De-identified data may also be sent directly to HMH investigators for their own analysis with IRB approval of their projects 5. Data will be made available to governmental agencies as requested.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with confirmed or suspected COVID-19
• Condition: COVID-19
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
• Berry DA, Ip A, Lewis BE, Berry SM, Berry NS, MrKulic M, Gadalla V, Sat B, Wright K, Serna M, Unawane R, Trpeski K, Koropsak M, Kaur P, Sica Z, McConnell A, Bednarz U, Marafelias M, Goy AH, Pecora AL, Sawczuk IS, Goldberg SL. Development and validation of a prognostic 40-day mortality risk model among hospitalized patients with COVID-19. PLoS One. 2021 Jul 30;16(7):e0255228. doi: 10.1371/journal.pone.0255228. eCollection 2021.
• Biran N, Ip A, Ahn J, Go RC, Wang S, Mathura S, Sinclaire BA, Bednarz U, Marafelias M, Hansen E, Siegel DS, Goy AH, Pecora AL, Sawczuk IS, Koniaris LS, Simwenyi M, Varga DW, Tank LK, Stein AA, Allusson V, Lin GS, Oser WF, Tuma RA, Reichman J, Brusco L Jr, Carpenter KL, Costanzo EJ, Vivona V, Goldberg SL. Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study. Lancet Rheumatol. 2020 Oct;2(10):e603-e612. doi: 10.1016/S2665-9913(20)30277-0. Epub 2020 Aug 14.
• Ip A, Berry DA, Hansen E, Goy AH, Pecora AL, Sinclaire BA, Bednarz U, Marafelias M, Berry SM, Berry NS, Mathura S, Sawczuk IS, Biran N, Go RC, Sperber S, Piwoz JA, Balani B, Cicogna C, Sebti R, Zuckerman J, Rose KM, Tank L, Jacobs LG, Korcak J, Timmapuri SL, Underwood JP, Sugalski G, Barsky C, Varga DW, Asif A, Landolfi JC, Goldberg SL. Hydroxychloroquine and tocilizumab therapy in COVID-19 patients-An observational study. PLoS One. 2020 Aug 13;15(8):e0237693. doi: 10.1371/journal.pone.0237693. eCollection 2020.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 11, 2022): 4496
• Original Estimated Enrollment (submitted: April 14, 2020): 5000
• Estimated Study Completion Date: March 2023
• Actual Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Confirmed or suspected COVID-19
• Data available via the EPIC system
• NO age restriction
• NO pregnancy restrictions

Exclusion Criteria:

• Patients on a clinical trial in which the treatment is blinded may be included in the database, however the study medication or treatment will be noted as "experimental" and not reported individually. NO efforts to "break" randomization or blinding will be permitted
• Patients may refuse to be tracked in the database and/or participate in this observational study. Given the lack of active "study" procedures in this observational database, formal informed consent is not required

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04347993
• Other Study ID Numbers: Pro2020-0342
• 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

• Current Responsible Party: Hackensack Meridian Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Hackensack Meridian Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andrew Ip, MD; Hackensack Meridian Health

• PRS Account: Hackensack Meridian Health
• Verification Date: May 2022