Topic: VIRUS COVID-19 registry: A Global Story

Speaker: Dr Rahul Kashyap, Division director for research, TriStar Division, HCA healthcare,  Nashville, TN. Assistant Professor, Anesthesiology, Mayo Clinic; Lead investigator for VIRUS COVId-19 registry

19th February, 2021, Saturday

9.30am-11am

• Viral Infection and Respiratory Illness Universal Study (VIRUS) is a collaboration of international investigators in the field of critical care, coordinated by Mayo Clinic and Society of Critical Care Medicine’s Discovery Critical Care Research Network. It is a cross sectional study which included all eligible Covid positive patients in ICU or on hospital floors. All participating sites are voluntary sites. There is no intervention. Complete de-identified data was collected.
• It is an accurate, generalizable near real-time data on Covid-19 in the last two years, though there is not much data on Omicron.
• The idea was to capture practice variation, not only in the US but also elsewhere.
• The Registry has data from 75,000 patients from 28 different countries in more than 300 sites who are contributing data either manually or through automation on the REDCap common data platform.
• There is also a pediatric version of the Registry of nearly 2500 patients, where more than 12 countries and 80 sites are contributing data.
• Data is mostly from US, but also Brazil, South America, Middle East, India, Japan and Europe.
• The dashboard can be accessed at https://sccmcovid19.org.
• The data gives information about male and female distribution, the top five comorbidities (HT, DM, dyslipidemia, obesity, CKD), the type of support the patients received (mechanical ventilation, NIV, HFNO, dialysis, ECMO) and the patient outcomes (duration of mechanical ventilation, ICU/hospital stay, discharged alive to home, other hospitals, long term care facility etc.)
• Nearly 60% of patients in the Registry had shortness of breath followed by fever, dry cough, myalgia. These have remained consistent throughout the Registry.
• The data is updated every week.
• The purpose was to harmonise the data and publish it so that people can adapt it. Though variable success, it is the largest database outside the government agencies and several publications have come out of the Registry.
• The Registry was introduced in a publication in in April 2020Critical Care Explorations, a journal of the Society of Critical Care Medicine.
• The Registry provided guiding principles on how to design or conduct observational critical care research for Covid-19.
• Another publication in the Critical Care Medicine journal looked at the outcomes of patients with Covid receiving organ support therapies.
• The journey began on March 11, when the idea of a Covid-19 Registry was conceived and protocol draft was initiated.
• On March 15, social media contacts were made, teams were formed and protocol revision began.
• On March 20, the first IRB was submitted, REDCap CRT design was initiated and initial invites were sent to sites.
• The first IRB approval was received on March 23 and the webpage was set up.
• The Registry was launched on March 31. First 16 sites were approved, SOPs were released and the first 10 patients were enrolled.
• This was the second global Registry after ISARIC WHO international database.
• The publication on “Outcomes of patients with Covid 19 receiving organ support therapies” was a highly cited paper during the Critical Care Meeting. It showed that in patients not on any organ support, the mortality was just 8%. If one organ support required, the mortality jumped to 40%. If two organ support required, the mortality increased to 53% and if three organ support required, mortality rose to nearly 72%. Mortality chances increase if organ support required regardless of age.
• REDCap is the data collection instrument of the Registry.
• A minimal dataset was created, which included SOFA, APACHE score, medications, signs and symptoms, ICU/hospital stay, etc. in addition to patient demographics.
• The Registry also created a reward system “What is in it for me”. If a particular site data is utilized in any publication, that site gets collaborative coauthorship. Any site could submit an idea for an ancillary study and publish as first author, but they have to give coauthorship to other sites as well. Thirdly, all sites own their data and can publish anytime and present anywhere.
• By this year end, the Registry will open up for non-contributing investigators. But there are five minimum criteria: Appropriate legal approval for data sharing, local IRB/PI approval, REDCap access, minimum patients (50) and review (2 ancillary studies).
• In the first round, 64 ancillary proposals were received and 33 were approved; in the second round, 67 were received and 20+ were approved and in the third round 35 were received and 15+ were reviewed.
• In addition to Mayo Clinic and SCCM, the Registry has also collaborated with FDA, ACR, PointClickCare. Some collaboration with AHA, IDSA, SOAP and Ob Gy society are in process.
• The STOP-VIRUS (Structured Team-based, Optimal supportive care for VIRUS study) trial will be a part of the ongoing effort of the SCCM Discovery VIRUS Registry, which will be funded partially by the SCCM’s CDC grant for Covid-19. It will assess the effectiveness of virtual coaching/evidence-based resources in a pragmatic intervention trial to improve patient-centered outcomes (mortality, discharge home, ventilatory free days, ICU and hospital length of stay) and increase the proportion of ICU days in which optimal Covid-19 care is adhered to.
• Any question, which is clinically meaningful could be answered from the Registry since it is a large database from more than 300 countries.
• Majority of data in the early days was done manually. Now the variable are automated.
• The Registry now has unique patient data of 75,000 patients, more than 140 thousand patient days, more than 13 million data points, more than 3000 volunteers, more than 300 hospitals, 40 US states and 26 countries.
• More than 150 ancillary ideas have been submitted and more than 45 studies have been approved.
• Sixteen manuscripts have been published and 21 are in submission process.
• The VIRUS Covid-19 Registry sets an example of a rapidly deployed, international pandemic registry that seeks to provide near real-time analytics and information of intensive care treatments and outcomes for Covid-19 patients.

Participants

Member National Medical Associations

Dr Yeh Woei Chong, Singapore, Chair CMAAO

Dr Alvin Yee-Shing Chan, Hong Kong, Treasurer, CMAAO

Dr Marthanda Pillai, India Member World Medical Council, Advisor CMAAO

Dr Wonchat Subhachaturas, Thailand, Advisor CMAAO

Dr Wasiq Qazi, Pakistan, President-elect CMAAO

Dr Angelique Coetzee, South Africa

Dr Akhtar Hussain, South Africa

Dr Benito Atienza, Philippines

Dr Qaiser Sajjad, Pakistan

Prof Ashraf Nizami, Pakistan

Dr Salma Kundi, Pakistan

Dr Muh-Yong Yen, Taiwan

Dr Prakash Budhathoki, Nepal

Invitees

 

Dr Rahul Kashyap, USA

Dr Russell D’Souza, Australia UNESCO Chair in Bioethics

Dr Monica Vasudev, USA

Dr Mulazim Hussain Bukhari, Pakistan

Dr Patricia La’Brooyi

Dr Nang Fong Chan

Dr Cheng Jew Ping

Dr EC Ng

Dr Nicholas Veliotes

Dr Gan Wei Lin

Dr Danny Hu

Dr Edward Pang

Dr Andiswa Nzimela

Dr L Soh

Dr Nidhi Dhawan

Dr Manisha Kukreja

Dr S Sharma, Editor IJCP Group

Moderator

Mr Saurabh Aggarwal