Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry (COVID-19)

April 22, 2024 updated by: Juan Pablo Domecq Garces, Mayo Clinic

Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)

Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators aim is to create a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.

Such a set of standards would increase the quality of single and multi-center studies, national registries as well as aggregation syntheses such as meta-analyses. It will also be of utmost importance in tiring times of public health emergencies and will help understand practice variability and outcomes during COVID-19 pandemic.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60056
        • Not yet recruiting
        • Society of Critical Care Medicine (150+ sites)
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Rahul Kashyap
        • Contact:
        • Sub-Investigator:
          • Ognjen Gajic, MD
        • Sub-Investigator:
          • Vikas Bansal, MBBS, MPH
        • Sub-Investigator:
          • John C O'Horo, MD, MPH
        • Sub-Investigator:
          • Aysun Tekin, MD
        • Principal Investigator:
          • Juan Pablo Domecq Garces, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COVID-19 Hospitalized patients

Description

Inclusion Criteria:

  • COVID-19 PCR positive (within 7 days)
  • COVID-19 PCR pending
  • COVID-19 high clinical suspicion

Exclusion Criteria:

  • Patient without Prior Research Authorization (applicable to Mayo Clinic sites)
  • Non COVID-19 related admissions
  • Repeated Admission to ICUs/Hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID19 test positive/pending or high clinical suspicion
COVID19 test positive/pending/high clinical suspicion- patient admitted to hospital
Other: observational
No Intervention
Other Names:
  • No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU and hospital mortality of COVID-19 patients
Time Frame: 7 days
Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 days mortality
Time Frame: 30 days
Secondary outcome will be to measure 30 days mortality from Hospital discharge
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Boston University
Society of Critical Care Medicine

Investigators

  • Principal Investigator: Juan Pablo Domecq Garces, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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