N/A
Completed N=4,588
A Prospective "Universal" Observational Database for COVID-19
Source: ClinicalTrials.gov NCT04347993 ↗Enrolled (actual)
4,588
Serious AEs
20.3%
Results posted
Sep 2024
Primary outcomePrimary: Need for Hospitalization — 3389 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Hospitalization |
3389 | — |
| PRIMARY Duration of Hospitalization |
8.93 | — |
| PRIMARY Need for ICU/Ventilator Support |
853 | — |
| PRIMARY Duration of Ventilator Support |
11.39 | — |
| PRIMARY Overall Survival Rate |
3463 | — |
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
Data sourced from ClinicalTrials.gov (NCT04347993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.