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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

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.

Condition or disease
COVID-19

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Real World Observational Database for COVID-19 Treatment and Outcomes
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021



Primary Outcome Measures :
  1. Need for hospitalization [ Time Frame: 1 Year ]
    Rate of Hospitalization

  2. 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.

  3. Need for ICU/Ventilator Support [ Time Frame: 1 Year ]
    Rate of ICU/Ventilator Support

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed or suspected COVID-19
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347993


Contacts
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Contact: Brittany Sinclaire 551-996-8073 Brittany.Sinclaire@HackensackMeridian.org
Contact: Urszula Bednarz 551-996-5799 Urszula.Bednarz@HackenasckMeridian.org

Locations
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United States, New Jersey
Hackensack Meridian Health - John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Brittany Sinclaire    551-996-8073    Brittany.Sinclaire@HackensackMeridian.org   
Contact: Urszula Bednarz    551-996-5744    Urszula.Bednarz@HackensackMeridian.org   
Principal Investigator: Andrew Ip, MD         
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Andrew Ip, MD Hackensack Meridian Health
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04347993    
Other Study ID Numbers: Pro2020-0342
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hackensack Meridian Health:
Coronavirus
Covid19
SARS-CoV-2