Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg) (CovidSurg)

• ClinicalTrials.gov Identifier: NCT04323644
• Recruitment Status: Unknown
• First Posted: March 26, 2020
• Last Update Posted: May 12, 2020
• Sponsor: University of Birmingham
• Information provided by (Responsible Party): University of Birmingham

Tracking Information

• First Submitted Date: March 25, 2020
• First Posted Date: March 26, 2020
• Last Update Posted Date: May 12, 2020
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 25, 2020)

30-day mortality [ Time Frame: 30 days ]

Death up to 30-days post surgery

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 25, 2020)

• 7-day mortality [ Time Frame: 7 days post surgery ]
  Death up to 7-days post surgery
• 30-day reoperation [ Time Frame: Up to 30-days post surgery ]
  Reoperation up to 30-days post surgery
• Postoperative ICU admission [ Time Frame: Up to 30 days post surgery ]
  Admission to ICU post surgery
• Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]
  Respiratory failure post surgery
• Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]
  Acute respiratory distress syndrome post surgery
• Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]
  Sepsis post surgery

• 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: Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
• Official Title: Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
• Brief Summary: CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.

Detailed Description

There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

The primary aim of the study is to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. In doing so, this will inform future risk stratification, decision making, and patient consent.

CovidSurg is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

• 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: Patients with COVID-19 infection who undergo surgery

Condition

• COVID-19
• Coronavirus
• Surgery

Intervention

Procedure: Surgery

Emergency or elective surgery

Study Groups/Cohorts

Cohort 1

Patients with COVID-19 infection undergoing surgery

Intervention: Procedure: Surgery

Publications *

• COVIDSurg Collaborative. Outcomes after perioperative SARS-CoV-2 infection in patients with proximal femoral fractures: an international cohort study. BMJ Open. 2021 Nov 30;11(11):e050830. doi: 10.1136/bmjopen-2021-050830.
• Seeliger B, Philouze G, Cherkaoui Z, Felli E, Mutter D, Pessaux P. Acute abdomen in patients with SARS-CoV-2 infection or co-infection. Langenbecks Arch Surg. 2020 Sep;405(6):861-866. doi: 10.1007/s00423-020-01948-2. Epub 2020 Jul 27.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 25, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients undergoing ANY type of surgery in an operating theatre, this includes obstetrics

AND

- The patient had COVID-19 infection either at the time of surgery or within 30 days of surgery, based on

(i) positive COVID-19 lab test or computed tomography (CT) chest scan

OR

(ii) clinical diagnosis (no COVID-19 lab test or CT chest performed)

Exclusion Criteria:

• If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04323644
• Other Study ID Numbers: CS-20200324
• Has Data Monitoring Committee: Yes

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
• Plan Description: No individual participant data will be available to other researchers

• Current Responsible Party: University of Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Birmingham
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Birmingham
• Verification Date: May 2020