Trial Outcomes & Findings for A Prospective "Universal" Observational Database for COVID-19 (NCT NCT04347993)

NCT ID: NCT04347993

Last Updated: 2024-09-03

Results Overview

Number of Participants needing hospitalization

Recruitment status

COMPLETED

Target enrollment

4588 participants

Primary outcome timeframe

1 Year

Results posted on

2024-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Confirmed or Suspected COVID-19 Confirmed or suspected COVID-19 with data available via the EPIC system. There are no age restrictions or pregnancy restrictions
Overall Study STARTED	4588
Overall Study COMPLETED	4588
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Due to the nature of the retrospective study, not all baseline measures were available in the electronic medical record for all participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Confirmed or Suspected COVID-19 n=4588 Participants Confirmed or suspected COVID-19 Data available via the EPIC system
Age, Continuous	60.43 years STANDARD_DEVIATION 18.13 • n=4522 Participants • Due to the nature of the retrospective study, not all baseline measures were available in the electronic medical record for all participants.
Sex: Female, Male Female	1914 Participants n=4523 Participants • Due to the nature of the retrospective study, not all baseline measures were available in the electronic medical record for all participants.
Sex: Female, Male Male	2609 Participants n=4523 Participants • Due to the nature of the retrospective study, not all baseline measures were available in the electronic medical record for all participants.
Ethnicity (NIH/OMB) Hispanic or Latino	1041 Participants n=4588 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2136 Participants n=4588 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1411 Participants n=4588 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4588 Participants
Race (NIH/OMB) Asian	175 Participants n=4588 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4588 Participants
Race (NIH/OMB) Black or African American	436 Participants n=4588 Participants
Race (NIH/OMB) White	2249 Participants n=4588 Participants
Race (NIH/OMB) More than one race	0 Participants n=4588 Participants
Race (NIH/OMB) Unknown or Not Reported	1728 Participants n=4588 Participants

PRIMARY outcome

Timeframe: 1 Year

Number of Participants needing hospitalization

Outcome measures

Outcome measures
Measure	Patients With Confirmed or Suspected COVID-19 n=4588 Participants Confirmed or suspected COVID-19 Data available via the EPIC system
Need for Hospitalization	3389 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Hospitalized Patients

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.

Outcome measures

Outcome measures
Measure	Patients With Confirmed or Suspected COVID-19 n=3010 Participants Confirmed or suspected COVID-19 Data available via the EPIC system
Duration of Hospitalization	8.93 Days Standard Deviation 10.89

PRIMARY outcome

Timeframe: 1 Year

Rate of ICU/Ventilator Support

Outcome measures

Outcome measures
Measure	Patients With Confirmed or Suspected COVID-19 n=4588 Participants Confirmed or suspected COVID-19 Data available via the EPIC system
Need for ICU/Ventilator Support	853 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Confirmed or Suspected COVID-19 n=681 Participants Confirmed or suspected COVID-19 Data available via the EPIC system
Duration of Ventilator Support	11.39 Days Standard Deviation 10.24

PRIMARY outcome

Timeframe: 1 Year

Overall survival will be defined as rate of patients alive at end of follow up

Outcome measures

Outcome measures
Measure	Patients With Confirmed or Suspected COVID-19 n=4396 Participants Confirmed or suspected COVID-19 Data available via the EPIC system
Overall Survival Rate	3463 Participants

Adverse Events

Patients With Confirmed or Suspected COVID-19

Serious events: 933 serious events

Other events: 0 other events

Deaths: 933 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Confirmed or Suspected COVID-19 n=4588 participants at risk Confirmed or suspected COVID-19 included in the COVID-19 Database Data available via the EPIC system
Investigations Death	20.3% 933/4588 • Number of events 933 • Adverse events were collected for 1 year but this is an observational study and there was no intervention introduced for research purposes.

Other adverse events

Adverse event data not reported

Additional Information

Joshua Zenreich

Hackensack Meridian Health

Phone: 5519965900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place