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

• ClinicalTrials.gov Identifier: NCT04323787
• Recruitment Status: Recruiting
• First Posted: March 27, 2020
• Last Update Posted: April 20, 2023
• Sponsor: Mayo Clinic
• Collaborators: Society of Critical Care Medicine; Boston University
• Information provided by (Responsible Party): Juan Pablo Domecq Garces, Mayo Clinic

Tracking Information

• First Submitted Date: March 24, 2020
• First Posted Date: March 27, 2020
• Last Update Posted Date: April 20, 2023
• Actual Study Start Date: March 30, 2020
• Estimated Primary Completion Date: March 31, 2024 (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

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 *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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; Society of Critical Care Medicine Discovery Viral Infection and Respiratory Illness Universal Study (VIRUS): COVID-19 Registry Investigator Group. 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 19, 2023): 100000
• Original Estimated Enrollment (submitted: March 25, 2020): 50000
• Estimated Study Completion Date: March 31, 2024
• Estimated Primary Completion Date: March 31, 2024 (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

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

• Current Responsible Party: Juan Pablo Domecq Garces, Mayo Clinic
• Original Responsible Party: Rahul Kashyap, Mayo Clinic, Principal Investigator
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current

Collaborators

• Society of Critical Care Medicine
• Boston University

Investigators

• Principal Investigator: Juan Pablo Domecq Garces, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: April 2023