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Discovery VIRUS COVID-19 Registry


Discovery
Viral Infection and Respiratory Illness Universal Study:
COVID-19 Registry and Validation of Critical Care Data Dictionary (C2D2)

Information for enrollment in registry

Please review the VIRUS participating sites before enrolling in the study, to see if your site is already enrolled. Click on this link.

To participate as a site, please complete this intake form. 

For frequently asked questions, please review the VIRUS FAQs.

For individuals whose site is IRB approved please join the SCCM Connect webpage via VIRUS COVID-19 Registry
Access includes a listserve of all participating sites, registry resources and updates of the VIRUS Registry Project.

VIRUS Dashboard

VIRUS COVID-19 Registry Dashboard now available! VIRUS Dashboard

What is the VIRUS?

VIRUS is a cross-sectional, observational study and registry of all eligible adult and pediatric patients who are admitted to a hospital. There is no intervention or patient interaction. Only de-identified data will be used for analysis.

ClinicalTrials.gov Identifier: NCT04323787

Inclusion and Exclusion Criteria:

Inclusion:

  • COVID-19 PCR (or other SARS-CoV-2) test positive (within 21 days)
  • COVID-19 PCR pending
  • COVID-19 high clinical suspicion

Exclusion

  • Non COVID-19 related admissions
  • Already included in VIRUS COVID-19 registry

What are the aims of the VIRUS?

Primary Aims:
Aim 1: Create a real time COVID-19 registry of current ICU and hospital care patterns to allow evaluation of safety and observational effectiveness of COVID-19 practices

Aim 2: Determine practice variations across different hospitals

Hypothesis: The registry will be essential for near-real time observational comparative effectiveness studies to learn effective treatment strategies and/or provide meaningful hypotheses for clinical trials.

Secondary Aims:
Aim 1: Prospectively validate standardized critical care data dictionary (C2D2) elements for Coronavirus Disease 2019 (COVID-19) in 50-100 community and academic hospitals across all 10 U.S. Department of Health & Human Services (HHS) regions and abroad.

Hypothesis: The critical care data dictionary will be easy to use and will facilitate timely data collection to analyze and inform the practive in real-time during the COVID-19 pandemic.

Aim 2: Develop a prototype of an EHR-based automated collection of standardized data elements for testing in two community and two academic hospitals equipped with a standard EHR.

Hypothesis: EHR-based automated collection will be feasible, valid and reliable (compared to manual data entry) with lower workload of data collection. 

VIRUS Investigators

Discovery, the Critical Care Research Network, is leading the efforts for this global COVID-19 registry.

Principal Investigator:
Rahul Kashyap, MBBS, MBA (Mayo Clinic)

Co-Principal Investigators:
Allen J. Walkey, MD, MSc (Boston University)
Vishakha Kumar, MD, MBA (Discovery, Society of Critical Care Medicine)

Institutional Review Board - Waiver of Consent

A waiver of informed consent for data collection is being requested for this study from participating sites. No patients will be contacted, but clinicians participating in the study will be surveyed for feedback and satisfaction.

Project Managers:
Karen Boman (Society of Critical Care Medicine)
Vikas Bansal, MBBS, MPH (Mayo Clinic)

For any questions, contact Vishakha Kumar.
Ancillary study proposals may be submitted for a subset of de-identified data for research purposes by investigators of participating sites in the VIRUS study. The proposals are submitted via an online submission portal. Once submitted, the proposal will be received by Discovery VIRUS Publication Review Workgroup & Discovery Steering Committee for approval amd feedback.
 
Datasets may be made available to outside groups (non-participating sites/investigators) after the initial publication of the data by VIRUS principal investigators. A DUA will need to be in place for this type of request.
 
The Discovery VIRUS Publication Review Workgroup will define the approvals via a transparent feedback mechanism to the investigators. For similar proposals (which are scored on par with each other), the review workgroup leadership will encourage investigators to collaborate on the topic. If collaboration is not feasible, preference will be given to the investigator who first  submitted the idea to the VIRUS ancillary study portal. The VIRUS project manager or study coordinator will reach out to the investigators for the list of data variables requested for the ancillary study.
 
Approval Process: The feedback on proposals will be shared with the investigators. The proposals that are approved, will have to follow the SCCM Discovery publications policies, that will be shared upon proposal approval. The Discovery VIRUS Publication Review Workgroup will make it a priority for rapid review of proposals based on the  timeline given below.
 
Information for investigators:
  1. Any conflict of interest with the ancillary study proposal will be disclosed by the reviewers and the investigators.
  2. The ancillary study proposals have been kept blinded from the VIRUS core investigator group. The first batch of ancillary proposals will be published once the review period closes and notifications are sent to the investigators.
  3. SCCM, including the VIRUS core investigators group, has the first right upon publication of the dataset for research hypothesis outlined for the VIRUS Study.
  4. Study participants can serve on the writing group with the VIRUS core investigators team, if their ancillary study ideas overlap or align with the VIRUS overall project aims.
  5. Collaboration (national & international) on ancillary proposal submissions are encouraged.
  6. Ancillary proposal approval and data sharing will also depend of data quality and completion of investigator’s own site data for the VIRUS study.
 
Timeline:
  Ancillary study proposal portal open Ancillary study proposal portal closed Review period Notification
First round of reviews April 15, 2020 May 30, 2020 June 1- June 30, 2020 By July 15, 2020
Second round of reviews July 15, 2020 September 30, 2020 Oct 1 – Oct 30, 2020 By Nov 15, 2020
Third round of reviews December 1, 2020 February 15, 2021 March 1 – March 30, 2021 By April 15, 2021
 
To submit a request for ancillary studies related to VIRUS please complete this application.
Walkey, Allan J. MD, MSc; Kumar, Vishakha K. MD, MBA; Harhay, Michael O. PhD; Bolesta, Scott PharmD; Bansal, Vikas MBBS, MPH; Gajic, Ognjen MD, MSc; Kashyap, Rahul MBBS, MBA; for the Society of Critical Care Medicine Discovery, Critical Care Research Network The Viral Infection and Respiratory Illness Universal Study (VIRUS): An International Registry of Coronavirus 2019-Related Critical Illness, Critical Care Explorations: April 2020 - Volume 2 - Issue 4 - p e0113
doi: 10.1097/CCE.0000000000000113