Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323644
Recruitment Status : Unknown
Verified May 2020 by University of Birmingham.
Recruitment status was:  Recruiting
First Posted : March 26, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
COVID-19 Coronavirus Surgery Procedure: Surgery

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Cohort 1
Patients with COVID-19 infection undergoing surgery
 Procedure: Surgery
Emergency or elective surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    Death up to 30-days post surgery


Secondary Outcome Measures :
  1. 7-day mortality [ Time Frame: 7 days post surgery ]
    Death up to 7-days post surgery

  2. 30-day reoperation [ Time Frame: Up to 30-days post surgery ]
    Reoperation up to 30-days post surgery

  3. Postoperative ICU admission [ Time Frame: Up to 30 days post surgery ]
    Admission to ICU post surgery

  4. Postoperative respiratory failure [ Time Frame: Up to 30 days post surgery ]
    Respiratory failure post surgery

  5. Postoperative acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 30 days post surgery ]
    Acute respiratory distress syndrome post surgery

  6. Postoperative sepsis [ Time Frame: Up to 30 days post surgery ]
    Sepsis post surgery


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COVID-19 infection who undergo surgery
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323644


Contacts
Layout table for location contacts
Contact: Aneel Bhangu +44 1216272949 A.A.Bhangu@bham.ac.uk
Contact: Dmitri Nepogodiev +44 1216272949 D.Nepogodiev@bham.ac.uk

Locations
Layout table for location information
Spain
Hospital del Henares Recruiting
Madrid, Spain
Contact: Ana Minaya-Bravo       Ana-minaya@hotmail.com   
Principal Investigator: Ana Minaya-Bravo         
Sponsors and Collaborators
University of Birmingham
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04323644    
Other Study ID Numbers: CS-20200324
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be available to other researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
COVID-19
Coronavirus
Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Coronavirus Infections
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases