SARS-COV-2LA-COVIDNCT05075928
Description of a Cohort of Covid-19 Patients With a Circulating Anticoagulant
An observational study of SARS-COV-2, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-COV-2
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to Nov 2021
- 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: Major patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment
Who may be able to join
- Adult patient (≥18 years old)
- Patient taken care of in the SMO pole or the NHC surgical resuscitation service or hospitalized or consultant to the HUS between 01/03/2020 and 31/05/2020
- Patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment
- or Patient infected with Covid-19, with a documented infection, without documented thrombosis (arterial or venous), with in the standard work-up an increase in TCA revealing the presence of LA
- Subject having given his agreement for the reuse of his data for the purposes of this research
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Anne-Sophie Korganow, MD, PhD, 33 3 69 55 05 21, Anne-sophie.Korganow@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). A significant proportion is also a carrier of circulating anticoagulant (ACC or LA), making it possible to suggest a diagnosis of APS. This type of autoantibody results in a spontaneous prolongation of the TCA uncorrected by a control serum therefore is quickly diagnosed using standard hemostasis The objective of this study is to describe the diagnosis of thrombotic complications in COVID19 patients presenting a positive lupus anticoagulant type test (LA) or aPL and the associated clinical and biological elements that may have favored thrombosis.
- Conditions
- SARS-COV-2
- Keywords
- SARS-COV-2, Covid-19, Antiphospholipid syndrome (APS), autoimmune disease, antiphospholipid antibodies (aPL), thrombosis
- Medical subject headings
- COVID-19, Antiphospholipid Syndrome, Autoimmune Diseases, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant
Measured: Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Jun 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-COV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie Korganow, MD, PhD, Principal investigator, Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075928
- Sponsor's protocol ID
- 7861
- Acronym
- LA-COVID
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of a Cohort of Covid-19 Patients With a Circulating Anticoagulant
- ClinicalTrials.gov ID
- NCT05075928
- Acronym / sponsor ID
- LA-COVID / 7861
- Conditions
- SARS-COV-2
- Keywords
- SARS-COV-2, Covid-19, Antiphospholipid syndrome (APS), autoimmune disease, antiphospholipid antibodies (aPL), thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 13 Oct 2021 (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.
SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). A significant proportion is also a carrier of circulating anticoagulant (ACC or LA), making it possible to suggest a diagnosis of APS. This type of autoantibody results in a spontaneous prolongation of the TCA uncorrected by a control serum therefore is quickly diagnosed using standard hemostasis The objective of this study is to describe the diagnosis of thrombotic complications in COVID19 patients presenting a positive lupus anticoagulant type test (LA) or aPL and the associated clinical and biological elements that may have favored thrombosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment
Key inclusion criteria (5 listed)
- Adult patient (≥18 years old)
- Patient taken care of in the SMO pole or the NHC surgical resuscitation service or hospitalized or consultant to the HUS between 01/03/2020 and 31/05/2020
- Patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment
- or Patient infected with Covid-19, with a documented infection, without documented thrombosis (arterial or venous), with in the standard work-up an increase in TCA revealing the presence of LA
- Subject having given his agreement for the reuse of his data for the purposes of this research
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant
Time frame: Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Anne-Sophie Korganow, MD, PhD principal investigator
Service de Médecine Interne et d'Immunologie Clinique - Hôpitaux Universitaires de Strasbourg
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 SARS-COV-2, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 3 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 1 Dec 2021. 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 France. 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 Anne-Sophie Korganow, MD, PhD (33 3 69 55 05 21, Anne-sophie.Korganow@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant (time frame: Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined]). 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 1 Dec 2021.