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CoronavirusCOVID-19NCT04323787

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

An observational study of Coronavirus, run by Mayo Clinic at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Any age
Conditions the study is for
Coronavirus
What is being tested?
observational
How many people
100,000 participants
Where
4 sitesUnited States
Study dates
30 Mar 2020to 31 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: COVID-19 Hospitalized patients

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Society of Critical Care Medicine (150+ sites)

    Chicago, Illinois, 60056

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Rahul Kashyap

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: 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.

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.

Conditions
Coronavirus
Being tested
observational
Keywords
COVID19
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observationalOther

    Also called No Intervention

    No Intervention

Study groups in NCT04323787
Study groupRoleWhat they receive
COVID19 test positive/pending or high clinical suspicionCOVID19 test positive/pending/high clinical suspicion- patient admitted to hospital
Receives: Other: observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days

Secondary outcomes (1)

  1. 30 days mortality

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start30 Mar 2020
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
100,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323787
Sponsor's protocol ID
20-002610
Acronym
COVID-19
Status last verified
Apr 2025
First submitted
24 Mar 2020
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tripathi S, McGarvey J, Montgomery V, Gharpure VP, Kashyap R, Walkey A, Bansal V, Boman K, Kumar VK, Kissoon N. Prevalence of Sepsis as Defined by Phoenix Sepsis Definition Among Children With COVID-19. Hosp Pediatr. 2025 Jul 1;15(7):554-562. doi: 10.1542/hpeds.2024-008161.

    PubMed 40545259

  • Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.

    PubMed 40028879

  • Tekin A, Qamar S, Sharma M, Singh R, Malinchoc M, Bansal V, Deo N, Bogojevic M, Valencia-Morales DJ, Zec S, Zorko-Garbajs N, Sharma N, Lal A, Sanghavi DK, Cartin-Ceba R, Khan SA, La Nou AT, Cherian A, Zabolotskikh IB, Kumar VK, Kashyap R, Walkey AJ, Domecq JP, Yadav H, Gajic O, Odeyemi YE; Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group. Development and Validation of an Acute Respiratory Distress Syndrome Prediction Model in Coronavirus Disease 2019: Updated Lung Injury Prediction Score. Mayo Clin Proc. 2023 May;98(5):736-747. doi: 10.1016/j.mayocp.2022.11.021. Epub 2022 Dec 30.

    PubMed 37028977

  • 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.

    PubMed 33555777

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus, run by Mayo Clinic at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICU and hospital mortality of COVID-19 patients (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323787, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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