COVID-19 ICU REGISTRY

Reportedly originated in Wuhan (China) in early December, the Coronavirus disease-2019 (COVID-19) is currently spreading all over the world, with over one million reported cases and 50,000 casualties reported to date. [1]. The responsible pathogen has been identified as a novel virus named "severe acute respiratory syndrome coronavirus-2" (SARS-CoV-2) [2].

On March 11, the World Health Organization declared that COVID-19 could be characterized as a pandemic [3]. The clinical manifestations range from mild inflammatory upper respiratory syndrome to severe diffuse viral pneumonia. In China, the overall reported fatality rate is about 2.2% in patients with proven infection [4]. In hospitalized patients with COVID-19, about 25% require admission to the ICU. Of these, 61% of patients meet the clinical criteria for acute respiratory distress syndrome (ARDS) [5].

Preliminary reports from Italy indicate an even higher disease severity [6]. In the United States, the incidence of COVID-19 cases is rising at an extremely rapid pace. The U.S. has soon become the country with the highest number of cases diagnosed at present. It is estimated that the deadly pathogen could kill between 100,000 and 240,000 Americans.

In several countries worldwide, a rapid exponential increase in the number of critically ill patients due to respiratory failure rapidly exceeded the total ICU capacity in the days immediately following the beginning of the outbreak, despite the prompt response of governments, hospitals and health authorities [7].

The risk for any healthcare system to be quickly overwhelmed by the surge in patients requiring ICU admission is real, with the potential to further increased mortality. The field of critical care must be unite and proactive all over the world in the data collection and sharing effort in order to provide time-sensitive information and guidance to the whole community.

No specifically targeted-treatment against the SARS-CoV-2 virus is available to-date. In separate randomized clinical studies, as a research group, we are currently focusing on inhaled nitric oxide gas (iNO), a pulmonary vasodilator which has shown antiviral activity against Coronavirus during the 2003 SARS outbreak [8,9].

However, in the current global health threat scenario, it might not be feasible to conduct appropriately designed interventional studies in every location. Observational data from a large dataset generated by a consortium of international institutions might help provide useful information and aid in the management of the crisis.

We designed a data collection strategy focusing on COVID-19 patients admitted to the ICU due to critical illness. Data can be entered in the registry both prospectively and retrospectively, provided a reliable source of clinical data is available within the center. The project has been approved by the Mass General Brigham Institutional Review Board (Protocol #: 2020P000760).

The purpose of this study is to deploy a global, secure, user-friendly, adaptive, and reliable registry platform aimed at gathering insight into how critically ill patients due to COVID-19 are currently being treated worldwide.

Thanks to a fast-paced turnover of data analysis and sharing we aim at providing the ICU community reliable information on important endpoints, such as:

• A global snapshot of the population of patients admitted to the ICU due to COVID-19
• The impact of pharmacologic therapies or rescue strategies being clinically implemented, like iNO or prone positioning
• The assessment of risk factors and biomarkers to more precisely stratify the severity of disease
• The impact of pharmacologic therapies currently being clinically used
• Outcome prediction and survival analysis in order to provide useful information for the planning of the response by hospitals and healthcare systems

References

[1] https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

[2] https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it

[3] https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020

[4] Guan, W.-J., Ni, Z.-Y., Hu, Y., Liang, W.-H., Ou, C.-Q., He, J.-X., … China Medical Treatment Expert Group for Covid-19. (2020). Clinical Characteristics of Coronavirus Disease 2019 in China. The New England Journal of Medicine, 1–13. https://doi.org/10.1056/NEJMoa2002032

[5] Yang, X., Yu, Y., Xu, J., Shu, H., Xia, J., Liu, H., … Shang, Y. (2020). Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. The Lancet Respiratory Medicine, 2600(20), 1–7. https://doi.org/10.1016/S2213-2600(20)30079-5

[6] https://lab.gedidigital.it/gedi-visual/2020/coronavirus-in-italia/

[7] Grasselli, G., Pesenti, A., & Cecconi, M. (2020). Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy. JAMA. https://doi.org/10.1001/jama.2020.4031

[8] https://www.medrxiv.org/content/10.1101/2020.03.10.20033522v1

[9] https://www.medrxiv.org/content/10.1101/2020.03.10.20033522v1

Meet our Team

Massachusetts General Hospital

	Riccardo Pinciroli, MD Research Staff Instructor in Anesthesia, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Lorenzo Berra, MD Anesthesiologist and Critical Care Physician Medical Director, Respiratory Care Reginald Jenney Associate Professor, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Fumito Ichinose, MD, PhD Cardiac Anesthesiologist William Thomas Green Morton Professor of Anaesthesia at Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Edward A. Bittner, MD Anesthesiologist and Critical Care Physician Program Director, Critical Care-Anesthesiology Fellowship Associate Director, Surgical Intensive Care Unit Associate Professor of Anaesthesia, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Robert Kacmarek, PhD Director of Respiratory Care Professor of Anaesthesia, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Seun Johnson-Akeju, MD Anesthetist-in-Chief, Massachusetts General Hospital Associate Professor of Anaesthesia, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Warren Zapol, MD Emeritus Anesthetist-in-Chief, Distinguished Reginald Jenney Professor of Anaesthesia, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
	Alexander Nagrebetsky, MD Anesthesiologist and Critical Care Physician Assistant Professor, Harvard Medical School Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Daniel S. Talmor, MD, MPH Chair, Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center Edward Lowenstein Professor of Anaesthesia, Harvard Medical School

Participate

If you are interested in participating, please send an email with the following information to rpinciroli@mgh.harvard.edu:

• First and last name
• Email address
• Phone number
• Institution

Data Entry

The purpose of the study database is to track subject enrollment, capture data elements in a series of short, well-designed forms all available on-line via a secure web portal, and facilitate the transfer of data into statistical packages for analysis.

The database application, called Studytrax, uses MS SQL Server as the back end relational database. The program is presently being used at dozens of major academic research centers to support numerous NIH funded projects and is available commercially (http://www.studytrax.com/). The HIPAA privacy rules and HIPAA security rules mandate that covered entities have in place appropriate policies and procedures to protect the confidentiality and security of protected health information. In compliance with these regulations, the database security features of Studytrax target multiple levels including the data element (e.g., restricted access to fields), user (e.g., password authentication access), application (e.g., role-based access to features, access audit trails), and hosting services (e.g., firewall, secure sockets layer).

Taken together, these features ensure access control, audit control, data integrity, user authentication, and transmission security. The research project is set up in Studytrax to ensure exported datasets are de-identified as defined in the HIPAA privacy regulation [45 C.F.R. §164.514 (b)(2)]. A 21 CFR Part 11 compliance document is available upon request from the creators of the software, a company called ScienceTRAX, LLC.