Clinical trial NCT04347993: A Prospective "Universal" Observational Database for COVID-19
Official title: Real World Observational Database for COVID-19 Treatment and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Coronavirus
Covid19
SARS-CoV-2
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 4588
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed or suspected COVID-19

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.

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

Primary outcomes:
measure: Need for Hospitalization
timeFrame: 1 Year
measure: Duration of Hospitalization
timeFrame: 1 Year
measure: Need for ICU/Ventilator Support
timeFrame: 1 Year
measure: Duration of Ventilator Support
timeFrame: 1 Year
measure: Overall Survival Rate
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Meridian Health - John Theurer Cancer Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Andrew Ip, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.