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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Tracking Information | |||||
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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 |
30-day mortality [ Time Frame: 30 days ] Death up to 30-days post surgery
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Other |
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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 |
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Intervention | Procedure: Surgery
Emergency or elective surgery
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Study Groups/Cohorts | Cohort 1
Patients with COVID-19 infection undergoing surgery
Intervention: Procedure: Surgery
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
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:
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:
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Sex/Gender |
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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 | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04323644 | ||||
Other Study ID Numbers | CS-20200324 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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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 |