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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 : July 23, 2021
Sponsor:
Collaborators:
Society of Critical Care Medicine
Boston University
Information provided by (Responsible Party):
Rahul Kashyap, Mayo Clinic

Tracking Information
First Submitted Date March 24, 2020
First Posted Date March 27, 2020
Last Update Posted Date July 23, 2021
Actual Study Start Date March 30, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 25, 2020)
30 days mortality [ Time Frame: 30 days ]
Secondary outcome will be to measure 30 days mortality from Hospital discharge
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry
Official Title Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population COVID-19 Hospitalized patients
Condition Coronavirus
Intervention Other: observational
No Intervention
Other Name: No Intervention
Study Groups/Cohorts COVID19 test positive/pending or high clinical suspicion
COVID19 test positive/pending/high clinical suspicion- patient admitted to hospital
Intervention: Other: observational
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 25, 2020)
50000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Rahul Kashyap, MBBS 5072557196 Kashyap.Rahul@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04323787
Other Study ID Numbers 20-002610
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rahul Kashyap, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators
  • Society of Critical Care Medicine
  • Boston University
Investigators
Principal Investigator: Rahul Kashya, MBBS Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2021