Covid19NCT04615026
Prevalence of Thrombosis in COVID-Patients
An observational study of Covid19, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- duplex sonography
- How many people
- 525 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2020to 30 Jun 2021
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: all SARS CoV 2 positive patients registered at local health departments (Augsburg) are invited to join the study
Who may be able to join
- SARS CoV 2 positive swap, at least 4 weeks after infection
Who cannot join
- under 18 years old no consent anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Thrombosis in COVID-Patients in Correlation to Humoral and Cellular Immunity
Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection.
- Conditions
- Covid19
- Being tested
- duplex sonography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duplex sonographyDiagnostic test
Also called test of smell, cognitive test, blood sample
all patients with consent receive a duplex ultrasound, blood test, cognitive test and test of smelling
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 patients | all patients with positive SARS-CoV 2 swap Receives: Diagnostic Test: duplex sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of thrombosis
Measured: 20 minutes
Secondary outcomes (2)
correlation to immunity
Measured: 20 minutes
Assessment of late complications
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start4 Nov 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Hyhlik-Dürr, University Hospital Augsburg
- Investigators
- Alexander Hyhlik-Duerr, MD, Principal investigator, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615026
- Sponsor's protocol ID
- COVID Thrombose
- Status last verified
- May 2022
- First submitted
- 3 Nov 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data as pseudonyms
Publications
Schmidbauer L, Kirchberger I, Gosslau Y, Warm TD, Hyhlik-Durr A, Linseisen J, Meisinger C. The association between the number of symptoms and the severity of Post-COVID-Fatigue after SARS-CoV-2 infection treated in an outpatient setting. J Neurol. 2023 Jul;270(7):3294-3302. doi: 10.1007/s00415-023-11752-9. Epub 2023 May 23.
PubMed 37219607
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Thrombosis in COVID-Patients in Correlation to Humoral and Cellular Immunity
- ClinicalTrials.gov ID
- NCT04615026
- Acronym / sponsor ID
- COVID Thrombose
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Nov 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.
Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID 19 patients | – | Diagnostic Test: duplex sonographyall patients with positive SARS-CoV 2 swap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all SARS CoV 2 positive patients registered at local health departments (Augsburg) are invited to join the study
Key inclusion criteria (1 listed)
- SARS CoV 2 positive swap, at least 4 weeks after infection
Key exclusion criteria (1 listed)
- under 18 years old no consent anemia
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 |
|---|---|---|
| duplex sonographyAlso: test of smell, cognitive test, blood sampleall patients with consent receive a duplex ultrasound, blood test, cognitive test and test of smelling | Diagnostic test | COVID 19 patients |
Primary outcome
prevalence of thrombosis
Time frame: 20 minutes
2 secondary outcomes
correlation to immunity
Time frame: 20 minutes
Assessment of late complications
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 37219607Schmidbauer L, Kirchberger I, Gosslau Y, Warm TD, Hyhlik-Durr A, Linseisen J, Meisinger C. The association between the number of symptoms and the severity of Post-COVID-Fatigue after SARS-CoV-2 infection treated in an outpatient setting. J Neurol. 2023 Jul;270(7):3294-3302. doi: 10.1007/s00415-023-11752-9. Epub 2023 May 23.
- Individual participant dataSharing planned: Undecided. data as pseudonyms
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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.
Alexander Hyhlik-Duerr, MD principal investigator
University Hospital Augsburg
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, run by University Hospital Augsburg at 1 site in Germany.
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: finished, as of the sponsor's last update on 2 Jun 2022. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of thrombosis (time frame: 20 minutes). 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 NCT04615026, which also lists 1 linked publication.
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 2 Jun 2022.