NCT04347993

A Prospective "Universal" Observational Database for COVID-19

Completed Results posted Last updated 3 September 2024

What this trial tests

trial in COVID-19 in 4,588 participants. Completed in 12 June 2023.

Timeline

27 March 2020

Primary endpoint
12 June 2022

12 June 2023

Quick facts

Lead sponsor	Hackensack Meridian Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,588
Start date	27 March 2020
Primary completion	12 June 2022
Estimated completion	12 June 2023
Sites	1 location across United States

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Hackensack Meridian Health — full company profile →

Who can join

Eligibility, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Need for Hospitalization Primary · 1 Year

Number of Participants needing hospitalization

Group	Value	95% CI
Patients With Confirmed or Suspected COVID-19	3389

Duration of Hospitalization Primary · 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.

Group	Value	95% CI
Patients With Confirmed or Suspected COVID-19	8.93	± 10.89

Need for ICU/Ventilator Support Primary · 1 Year

Rate of ICU/Ventilator Support

Group	Value	95% CI
Patients With Confirmed or Suspected COVID-19	853

Duration of Ventilator Support Primary · 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.

Group	Value	95% CI
Patients With Confirmed or Suspected COVID-19	11.39	± 10.24

Overall Survival Rate Primary · 1 Year

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

Group	Value	95% CI
Patients With Confirmed or Suspected COVID-19	3463

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for 1 year but this is an observational study and there was no intervention introduced for research purposes.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Confirmed or Suspected COVID-19

Serious: 933/4588 (20%)

Deaths: 933/4588

Serious adverse events (1 terms)

Reaction	System	Patients With Confirmed or…
Death	Investigations	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT04347993 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study.
   Biran N, Ip A, Ahn J, Go RC, et al · · 2020 · cited 210× · PMID 32838323 · DOI 10.1016/s2665-9913(20)30277-0
2. Hydroxychloroquine and tocilizumab therapy in COVID-19 patients-An observational study.
   Ip A, Berry DA, Hansen E, Goy AH, et al · · 2020 · cited 103× · PMID 32790733 · DOI 10.1371/journal.pone.0237693
3. SARS-CoV-2 Treatment Approaches: Numerous Options, No Certainty for a Versatile Virus.
   Iacob S, Iacob DG. · · 2020 · cited 27× · PMID 32982720 · DOI 10.3389/fphar.2020.01224
4. Infections of the lung: a predictive, preventive and personalized perspective through the lens of evolution, the emergence of SARS-CoV-2 and its pathogenesis.
   Ahluwalia P, Ahluwalia M, Vaibhav K, Mondal A, et al · · 2020 · cited 12× · PMID 33204369 · DOI 10.1007/s13167-020-00230-1
5. Methylprednisolone and 60 Days in Hospital Survival in Coronavirus Disease 2019 Pneumonia.
   Go RC, Shah R, Nyirenda T, Oe Y, et al · · 2021 · cited 10× · PMID 34291223 · DOI 10.1097/cce.0000000000000493
6. The Immunopathobiology of SARS-CoV-2 Infection.
   Patel M, Shahjin F, Cohen JD, Hasan M, et al · · 2021 · cited 9× · PMID 34160586 · DOI 10.1093/femsre/fuab035
7. Hydroxychloroquine and Tocilizumab Therapy in COVID-19 Patients – An Observational Study
   Ip A, Berry DA, Hansen E, Goy AH, et al · · 2020 · cited 8× · DOI 10.1101/2020.05.21.20109207
8. Repurposing of drugs targeting the cytokine storm induced by SARS-CoV-2.
   Ng WH, Tang PCH, Mahalingam S, Liu X. · · 2023 · cited 7× · PMID 36394425 · DOI 10.1111/bph.15987