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A Prospective "Universal" Observational Database for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347993
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : April 24, 2020
Sponsor:
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 April 24, 2020
Actual Study Start Date March 27, 2020
Estimated Primary Completion Date April 2021   (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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 14, 2020)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2021
Estimated Primary Completion Date April 2021   (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: Brittany Sinclaire 551-996-8073 Brittany.Sinclaire@HackensackMeridian.org
Contact: Urszula Bednarz 551-996-5799 Urszula.Bednarz@HackenasckMeridian.org
Listed Location Countries United States
Removed Location Countries  
 
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
Responsible Party Hackensack Meridian Health
Study Sponsor Hackensack Meridian Health
Collaborators Not Provided
Investigators
Principal Investigator: Andrew Ip, MD Hackensack Meridian Health
PRS Account Hackensack Meridian Health
Verification Date April 2020