Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg) (CovidSurg)
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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
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 Coronavirus Surgery | Procedure: Surgery |
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 |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Cohort 1
Patients with COVID-19 infection undergoing surgery
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Procedure: Surgery
Emergency or elective surgery |
- 30-day mortality [ Time Frame: 30 days ]Death up to 30-days post surgery
- 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

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.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Contact: Aneel Bhangu | +44 1216272949 | A.A.Bhangu@bham.ac.uk | |
Contact: Dmitri Nepogodiev | +44 1216272949 | D.Nepogodiev@bham.ac.uk |
Spain | |
Hospital del Henares | Recruiting |
Madrid, Spain | |
Contact: Ana Minaya-Bravo Ana-minaya@hotmail.com | |
Principal Investigator: Ana Minaya-Bravo |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Coronavirus Surgery |
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 |