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Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry (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: NCT04323787
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 20, 2023
Sponsor:
Collaborators:
Society of Critical Care Medicine
Boston University
Information provided by (Responsible Party):
Juan Pablo Domecq Garces, Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Coronavirus Other: observational

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 Design
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: No Intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 30 days mortality [ Time Frame: 30 days ]
    Secondary outcome will be to measure 30 days mortality from Hospital discharge


Eligibility Criteria
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Information from the National Library of Medicine

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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
COVID-19 Hospitalized patients
Criteria

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
Contacts and Locations
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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): NCT04323787


Contacts
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Contact: Rahul Kashyap, MBBS 5072557196 Kashyap.Rahul@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Ayan Sen, MD    480-342-2000    sen.ayan@mayo.edu   
Contact: Rodrigo Cartin-Ceba, MD       CartinCeba.Rodrigo@mayo.edu   
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Devang Sanghavi, MD    904-956-3331    Sanghavi.Devang@mayo.edu   
United States, Illinois
Society of Critical Care Medicine (150+ sites) Not yet recruiting
Chicago, Illinois, United States, 60056
Contact: Vishakha Kumar, MD    847-827-6869    vkumar@sccm.org   
United States, Minnesota
Rahul Kashyap Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rahul Kashyap    507-255-7196    Kashyap.Rahul@mayo.edu   
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         
Sponsors and Collaborators
Mayo Clinic
Society of Critical Care Medicine
Boston University
Investigators
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Principal Investigator: Juan Pablo Domecq Garces, MD Mayo Clinic
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juan Pablo Domecq Garces, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04323787    
Other Study ID Numbers: 20-002610
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023
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 Juan Pablo Domecq Garces, Mayo Clinic:
COVID19
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases