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CompletedNCT04323787COVID-19Updated Apr 27, 2025

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

An observational study in Coronavirus, sponsored by Mayo Clinic. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronavirus

Keywords

  • COVID19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 100,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COVID-19 Hospitalized patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient without Prior Research Authorization (applicable to Mayo Clinic sites)
  • Non COVID-19 related admissions
  • Repeated Admission to ICUs/Hospital
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100,000 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID19 test positive/pending or high clinical suspicion

    COVID19 test positive/pending/high clinical suspicion- patient admitted to hospital

    Other: observational

Interventions

  • Otherobservational

    No Intervention

    Also known as: No Intervention

06

What researchers measure

Primary outcomes

  1. ICU and hospital mortality of COVID-19 patients

    Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients

    Time frame: 7 days

Secondary outcomes

  1. 30 days mortality

    Secondary outcome will be to measure 30 days mortality from Hospital discharge

    Time frame: 30 days

07

Study locations

4 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
  • Society of Critical Care Medicine (150+ sites)
    Chicago, Illinois 60056, United States
  • Rahul Kashyap
    Rochester, Minnesota 55905, United States
08

References and documents

Publications

  • Gupta N, Settle L, Brown BR, Armaignac DL, Baram M, Perkins NE, Kaufman M, Melamed RR, Christie AB, Danesh VC, Denson JL, Cheruku SR, Boman K, Bansal V, Kumar VK, Walkey AJ, Domecq JP, Kashyap R, Aston CE; Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group. Association of Renin Angiotensin Aldosterone System Inhibitors and Outcomes of Hospitalized Patients With COVID-19. Crit Care Med. 2022 Oct 1;50(10):e744-e758. doi: 10.1097/CCM.0000000000005627. Epub 2022 Jul 27. PubMed 35894609 ↗
  • Garcia MA, Johnson SW, Sisson EK, Sheldrick CR, Kumar VK, Boman K, Bolesta S, Bansal V, Bogojevic M, Domecq JP, Lal A, Heavner S, Cheruku SR, Lee D, Anderson HL, Denson JL, Gajic O, Kashyap R, Walkey AJ; from the Society of Critical Care Medicine's Discovery Viral Infection and Respiratory Illness Universal Study Investigators. Variation in Use of High-Flow Nasal Cannula and Noninvasive Ventilation Among Patients With COVID-19. Respir Care. 2022 Aug;67(8):929-938. doi: 10.4187/respcare.09672. Epub 2022 Jun 7. PubMed 35672139 ↗
  • Sayed IA, Bhalala U, Strom L, Tripathi S, Kim JS, Michaud K, Chiotos K, Dapul HR, Gharpure VP, Bjornstad EC, Heneghan JA, Irby K, Montgomery V, Gupta N, Gupta M, Boman K, Bansal V, Kashyap R, Walkey AJ, Kumar VK, Gist KM; VIRUS Investigators. Gastrointestinal Manifestations in Hospitalized Children With Acute SARS-CoV-2 Infection and Multisystem Inflammatory Condition: An Analysis of the VIRUS COVID-19 Registry. Pediatr Infect Dis J. 2022 Sep 1;41(9):751-758. doi: 10.1097/INF.0000000000003589. Epub 2022 May 27. PubMed 35622434 ↗
  • Turek JR, Bansal V, Tekin A, Singh S, Deo N, Sharma M, Bogojevic M, Qamar S, Singh R, Kumar V, Kashyap R. Lessons From a Rapid Project Management Exercise in the Time of Pandemic: Methodology for a Global COVID-19 VIRUS Registry Database. JMIR Res Protoc. 2022 Mar 15;11(3):e27921. doi: 10.2196/27921. PubMed 34762062 ↗
  • Kirkup C, Pawlowski C, Puranik A, Conrad I, O'Horo JC, Gomaa D, Banner-Goodspeed VM, Mosier JM, Zabolotskikh IB, Daugherty SK, Bernstein MA, Zaren HA, Bansal V, Pickering B, Badley AD, Kashyap R, Venkatakrishnan AJ, Soundararajan V. Healthcare disparities among anticoagulation therapies for severe COVID-19 patients in the multi-site VIRUS registry. J Med Virol. 2021 Jul;93(7):4303-4318. doi: 10.1002/jmv.26918. Epub 2021 Mar 30. PubMed 33666246 ↗
  • Domecq JP, Lal A, Sheldrick CR, Kumar VK, Boman K, Bolesta S, Bansal V, Harhay MO, Garcia MA, Kaufman M, Danesh V, Cheruku S, Banner-Goodspeed VM, Anderson HL 3rd, Milligan PS, Denson JL, St Hill CA, Dodd KW, Martin GS, Gajic O, Walkey AJ, Kashyap R. Outcomes of Patients With Coronavirus Disease 2019 Receiving Organ Support Therapies: The International Viral Infection and Respiratory Illness Universal Study Registry. Crit Care Med. 2021 Mar 1;49(3):437-448. doi: 10.1097/CCM.0000000000004879. Erratum In: Crit Care Med. 2021 May 1;49(5):e562. doi: 10.1097/CCM.0000000000005007. PubMed 33555777 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04323787
Lead sponsor
Mayo Clinic
Collaborators
Society of Critical Care Medicine, Boston University
Responsible party
Juan Pablo Domecq Garces (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 27, 2020
Start date
Mar 30, 2020
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Last update
Apr 27, 2025

Study contacts

Juan Pablo Domecq Garces, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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