NCT04323787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

March 24, 2020

Last Update Submit

April 23, 2025

Conditions

Coronavirus

Keywords

COVID19

Outcome Measures

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

    7 days

Secondary Outcomes (1)

  • 30 days mortality

    30 days

Study Arms (1)

COVID19 test positive/pending or high clinical suspicion

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

Other: observational

Interventions

observationalOTHER

No Intervention

Also known as: No Intervention
COVID19 test positive/pending or high clinical suspicion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 Hospitalized patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Society of Critical Care Medicine (150+ sites)

Chicago, Illinois, 60056, United States

Location

Rahul Kashyap

Rochester, Minnesota, 55905, United States

Location

Related Publications (8)

  • 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.

    PMID: 40028879DERIVED

  • 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.

    PMID: 37028977DERIVED

  • 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.

    PMID: 35894609DERIVED

  • 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.

    PMID: 35672139DERIVED

  • 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.

    PMID: 35622434DERIVED

  • 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.

    PMID: 34762062DERIVED

  • 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.

    PMID: 33666246DERIVED

  • 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.

    PMID: 33555777DERIVED

Related Links

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Juan Pablo Domecq Garces, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

March 30, 2020

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)