COVID-19
Conditions
Keywords
Coronavirus, Covid19, SARS-CoV-2
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.
Interventions
None listed
Sponsors
Hackensack Meridian Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for Hospitalization | 1 Year | Number of Participants needing hospitalization |
| Duration of Hospitalization | 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 | 1 Year | Rate of ICU/Ventilator Support |
| Duration of Ventilator Support | 1 Year | The duration of Ventilator Support is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis. |
| Overall Survival Rate | 1 Year | Overall survival will be defined as rate of patients alive at end of follow up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Confirmed or Suspected COVID-19 Confirmed or suspected COVID-19 Data available via the EPIC system | 4,588 |
| Total | 4,588 |
Baseline characteristics
| Characteristic | Patients With Confirmed or Suspected COVID-19 |
|---|---|
| Age, Continuous | 60.43 years STANDARD_DEVIATION 18.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1041 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1411 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 175 Participants |
| Race (NIH/OMB) Black or African American | 436 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1728 Participants |
| Race (NIH/OMB) White | 2249 Participants |
| Sex: Female, Male Female | 1914 Participants |
| Sex: Female, Male Male | 2609 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 933 / 4,588 |
| other Total, other adverse events | 0 / 4,588 |
| serious Total, serious adverse events | 933 / 4,588 |
Outcome results
Primary
Duration of Hospitalization
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.
Time frame: 1 Year
Population: Hospitalized Patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Confirmed or Suspected COVID-19 | Duration of Hospitalization | 8.93 Days | Standard Deviation 10.89 |
Primary
Duration of Ventilator Support
The duration of Ventilator Support is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
Time frame: 1 Year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Confirmed or Suspected COVID-19 | Duration of Ventilator Support | 11.39 Days | Standard Deviation 10.24 |
Primary
Need for Hospitalization
Number of Participants needing hospitalization
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Confirmed or Suspected COVID-19 | Need for Hospitalization | 3389 Participants |
Primary
Need for ICU/Ventilator Support
Rate of ICU/Ventilator Support
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Confirmed or Suspected COVID-19 | Need for ICU/Ventilator Support | 853 Participants |
Primary
Overall Survival Rate
Overall survival will be defined as rate of patients alive at end of follow up
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Confirmed or Suspected COVID-19 | Overall Survival Rate | 3463 Participants |