COVID-19CovidSurgNCT04323644
Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
An observational study of COVID-19 and Coronavirus, run by University of Birmingham at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Coronavirus, Surgery
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COVID-19 infection who undergo surgery
Who may be able to join
- 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
- positive COVID-19 lab test or computed tomography (CT) chest scan
- OR
- clinical diagnosis (no COVID-19 lab test or CT chest performed)
Who cannot join
- If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Henares
Madrid
Ana Minaya-Bravo, Ana-minaya@hotmail.com
Ana Minaya-Bravo
About this study
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.
Read the 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.
- Conditions
- COVID-19, Coronavirus, Surgery
- Being tested
- Surgery
- Keywords
- COVID-19, Coronavirus, Surgery
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Emergency or elective surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with COVID-19 infection undergoing surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Death up to 30-days post surgery
Measured: 30 days
Secondary outcomes (6)
7-day mortality
Death up to 7-days post surgery
Measured: 7 days post surgery
30-day reoperation
Reoperation up to 30-days post surgery
Measured: Up to 30-days post surgery
Postoperative ICU admission
Admission to ICU post surgery
Measured: Up to 30 days post surgery
Postoperative respiratory failure
Respiratory failure post surgery
Measured: Up to 30 days post surgery
Postoperative acute respiratory distress syndrome (ARDS)
Acute respiratory distress syndrome post surgery
Measured: Up to 30 days post surgery
Postoperative sepsis
Sepsis post surgery
Measured: Up to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jan 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323644
- Sponsor's protocol ID
- CS-20200324
- Acronym
- CovidSurg
- Status last verified
- May 2020
- First submitted
- 25 Mar 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers
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.
PubMed 34848515Seeliger 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.
PubMed 32720012
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)
- ClinicalTrials.gov ID
- NCT04323644
- Acronym / sponsor ID
- CovidSurg / CS-20200324
- Conditions
- COVID-19, Coronavirus, Surgery
- Keywords
- COVID-19, Coronavirus, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: SurgeryPatients with COVID-19 infection undergoing surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COVID-19 infection who undergo surgery
Key inclusion criteria (6 listed)
- 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
- positive COVID-19 lab test or computed tomography (CT) chest scan
- OR
Key exclusion criteria (1 listed)
- If COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryEmergency or elective surgery | Procedure or surgery | Cohort 1 |
Primary outcome
30-day mortality
Time frame: 30 days
Death up to 30-days post surgery
6 secondary outcomes
7-day mortality
Time frame: 7 days post surgery
30-day reoperation
Time frame: Up to 30-days post surgery
Postoperative ICU admission
Time frame: Up to 30 days post surgery
Postoperative respiratory failure
Time frame: Up to 30 days post surgery
Postoperative acute respiratory distress syndrome (ARDS)
Time frame: Up to 30 days post surgery
Postoperative sepsis
Time frame: Up to 30 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 34848515COVIDSurg 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.
- Derived from this study: PubMed 32720012Seeliger 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.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Coronavirus, run by University of Birmingham at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aneel Bhangu (+44 1216272949, A.A.Bhangu@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04323644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.