NCT04323644

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

March 25, 2020

Last Update Submit

May 11, 2020

Conditions

Keywords

COVID-19CoronavirusSurgery

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Death up to 30-days post surgery

    30 days

Secondary Outcomes (6)

  • 7-day mortality

    7 days post surgery

  • 30-day reoperation

    Up to 30-days post surgery

  • Postoperative ICU admission

    Up to 30 days post surgery

  • Postoperative respiratory failure

    Up to 30 days post surgery

  • Postoperative acute respiratory distress syndrome (ARDS)

    Up to 30 days post surgery

  • +1 more secondary outcomes

Study Arms (1)

Cohort 1

Patients with COVID-19 infection undergoing surgery

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Emergency or elective surgery

Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COVID-19 infection who undergo surgery

You may qualify if:

  • 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
  • (ii) clinical diagnosis (no COVID-19 lab test or CT chest performed)

You may not qualify if:

  • If COVID-19 infection is diagnosed \>30 days after discharge, the patient should not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Henares

Madrid, Spain

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 26, 2020

Study Start

January 1, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

No individual participant data will be available to other researchers

Locations