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

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ClinicalTrials.gov Identifier: NCT04323644
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : May 12, 2020
Sponsor:
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
Change History
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 * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
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: Aneel Bhangu +44 1216272949 A.A.Bhangu@bham.ac.uk
Contact: Dmitri Nepogodiev +44 1216272949 D.Nepogodiev@bham.ac.uk
Listed Location Countries Spain
Removed Location Countries  
 
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
Responsible Party University of Birmingham
Study Sponsor University of Birmingham
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Birmingham
Verification Date May 2020