Covid19NCT04525716
The Effect of the Covid-19 Pandemic Among Operated Patients
An observational study of Covid19 and Surgery, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This project covers several research aims and uses different research methods, such as cohort analyses. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- COVID-19 infection status and Socioeconomic status
- How many people
- 300,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 that undergo surgical treatment in the Stockholm Region during the study period
Who may be able to join
- Patients that undergo surgical treatment in the Stockholm Region during the study period
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Nordberg, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
All acute care hospitals in Region Stockholm
Stockholm
Andreas Älgå, MD, PhD, 0702463287, andreas.alga@ki.se
About this study
Official title: What Are the Effects of the Covid-19 Pandemic Among Operated Patients? A Hospital Based Cohort in Stockholm, Sweden
This project covers several research aims and uses different research methods, such as cohort analyses.
Read the detailed description
Background:
A novel Coronavirus (SARS-CoV-2) was first detected in the Hubei Province in China in December, 2019. The virus causes a severe respiratory disease (Coronavirus disease 2019, COVID-19) that has rapidly spread worldwide. The COVID-19 pandemic is prognosed to affect a majority of the world's population before the end of 2020. Throughout the course of the pandemic, patients will continuously need essential healthcare, such as for acute surgical conditions. How the clinical course and management of surgical conditions is influenced by concomitant COVID-19 is largely unknown. There is an acute need for an improved evidence base to inform treatment strategies and guide the management of this patient group.
Objectives of initial analyses:
- To compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.
Methods:
The study will enroll consecutive patients that undergo surgical treatment in the Stockholm Region. Data will be extracted from a series of linked electronic systems, such as electronic healthcare records systems, and regional data systems. Collected data will include routine clinical data, such as baseline characteristics, previous medical history, details on care given at the hospital and data from follow-up visits. Endpoints include death, length of hospital stay and complications, such as readmission, reoperation, sepsis, respiratory failure, and number of days in the intensive care unit. Outcome data of patients with confirmed COVID-19 will be compared to those of patients without COVID-19.
Objectives and methods of further analyses:
By comparing surgical patients from different socioeconomic groups the investigators aim to assess whether socioeconomic status is associated with good or bad outcomes.
Dissemination and relevance:
To the best of the investigators knowledge, there has been no previous comprehensive comparative research on patients with and without confirmed COVID-19 that undergo surgical treatment.
The results will be disseminated through peer-reviewed publications, aiming for journals with a rapid editorial process, preferably open access journals. The findings are expected to increase the knowledge to establish best-treatment strategies and improve outcomes, both for patients affected by COVID-19 and by future epidemics.
- Being tested
- COVID-19 infection status, Socioeconomic status
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 infection statusOther
The investigators will compare patients with/without confirmed COVID-19 infection
Socioeconomic statusOther
Patients from different socioeconomic groups will be compared
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Patients with confirmed COVID-19 infection Receives: Other: COVID-19 infection status | |
| Non-COVID-19 | Patients without confirmed COVID-19 infection Receives: Other: COVID-19 infection status | |
| Socioeconomic status | Patients with varying socioeconomic status will be compared Receives: Other: Socioeconomic status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Mortality
Measured: 30 days post surgery
Secondary outcomes (2)
Length of stay
Length of hospital stay
Measured: Through study completion, an average of 1 month
Complications
Includes readmission, reoperation, infection, sepsis, respiratory failure, and number of days in the intensive care unit
Measured: 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Älgå, Karolinska Institutet
- Investigators
- Martin Nordberg, MD, PhD, Study chair, Karolinska Institutet, Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525716
- Sponsor's protocol ID
- CovidKirurgi
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2020
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Effects of the Covid-19 Pandemic Among Operated Patients? A Hospital Based Cohort in Stockholm, Sweden
- ClinicalTrials.gov ID
- NCT04525716
- Acronym / sponsor ID
- CovidKirurgi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Aug 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.
This project covers several research aims and uses different research methods, such as cohort analyses.
Detailed description
Background:
A novel Coronavirus (SARS-CoV-2) was first detected in the Hubei Province in China in December, 2019. The virus causes a severe respiratory disease (Coronavirus disease 2019, COVID-19) that has rapidly spread worldwide. The COVID-19 pandemic is prognosed to affect a majority of the world's population before the end of 2020. Throughout the course of the pandemic, patients will continuously need essential healthcare, such as for acute surgical conditions. How the clinical course and management of surgical conditions is influenced by concomitant COVID-19 is largely unknown. There is an acute need for an improved evidence base to inform treatment strategies and guide the management of this patient group.
Objectives of initial analyses:
- To compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.
Methods:
The study will enroll consecutive patients that undergo surgical treatment in the Stockholm Region. Data will be extracted from a series of linked electronic systems, such as electronic healthcare records systems, and regional data systems. Collected data will include routine clinical data, such as baseline characteristics, previous medical history, details on care given at the hospital and data from follow-up visits. Endpoints include death, length of hospital stay and complications, such as readmission, reoperation, sepsis, respiratory failure, and number of days in the intensive care unit. Outcome data of patients with confirmed COVID-19 will be compared to those of patients without COVID-19.
Objectives and methods of further analyses:
By comparing surgical patients from different socioeconomic groups the investigators aim to assess whether socioeconomic status is associated with good or bad outcomes.
Dissemination and relevance:
To the best of the investigators knowledge, there has been no previous comprehensive comparative research on patients with and without confirmed COVID-19 that undergo surgical treatment.
The results will be disseminated through peer-reviewed publications, aiming for journals with a rapid editorial process, preferably open access journals. The findings are expected to increase the knowledge to establish best-treatment strategies and improve outcomes, both for patients affected by COVID-19 and by future epidemics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Other: COVID-19 infection statusPatients with confirmed COVID-19 infection |
| Non-COVID-19 | – | Other: COVID-19 infection statusPatients without confirmed COVID-19 infection |
| Socioeconomic status | – | Other: Socioeconomic statusPatients with varying socioeconomic status will be compared |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that undergo surgical treatment in the Stockholm Region during the study period
Key inclusion criteria (1 listed)
- Patients that undergo surgical treatment in the Stockholm Region during the study period
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| COVID-19 infection statusThe investigators will compare patients with/without confirmed COVID-19 infection | Other | COVID-19, Non-COVID-19 |
| Socioeconomic statusPatients from different socioeconomic groups will be compared | Other | Socioeconomic status |
Primary outcome
Death
Time frame: 30 days post surgery
Mortality
2 secondary outcomes
Length of stay
Time frame: Through study completion, an average of 1 month
Complications
Time frame: 3 months post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Martin Nordberg, MD, PhD contact
Martin Nordberg, MD, PhD study chair
Karolinska Institutet, Södersjukhuset
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 Covid19 and Surgery, run by Karolinska Institutet at 1 site in Sweden.
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 1 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Älgå, MD, PhD (0702463287, andreas.alga@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.