COVID 19NCT04361786
Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection
An observational study of COVID 19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID 19
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen in Covid unity in Montpellier University Hospital
Who may be able to join
- Chilblains or vascular abnormalities (Raynaud's phenomenon, purpura, livedo, necrosis, acrocyanosis) of the acral skin (hands, feet, nose, ears) developping during or after a proved or suspected Covid-19 infection.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection: Search for Acquired Thrombophilia and Interferon-alpha Signature
Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood.
The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.
- Conditions
- COVID 19
- Keywords
- Suspected or proved Covid-19 virus infection, current or past, Chilblains, Interferon, Vasculitis
- Medical subject headings
- COVID-19, Chilblains, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological acquired thrombophilia
Searching for presence or absence of abnormal acquired thrombophilic condition as antibodies, hemostasis disturbances. Presence or absence of thrombophilic markers in the blood
Measured: 1 day
Secondary outcomes (1)
Overexpression of interferon type I
Dosing transcriptomic interferon signature in a blood sample. Presence or absence of interferon in the blood
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Lyon Sud Hospital Center, University Hospital, Marseille
- Responsible party
- Sponsor
- Investigators
- Didier BESSIS, PhD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361786
- Sponsor's protocol ID
- RECHMPL20_0211
- Status last verified
- Dec 2020
- First submitted
- 17 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection: Search for Acquired Thrombophilia and Interferon-alpha Signature
- ClinicalTrials.gov ID
- NCT04361786
- Acronym / sponsor ID
- RECHMPL20_0211
- Conditions
- COVID 19
- Keywords
- Suspected or proved Covid-19 virus infection, current or past, Chilblains, Interferon, Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Lyon Sud Hospital Center, University Hospital, Marseille
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 24 Apr 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.
Spectrum of skin lesions may arise during Covid-19 virus infection. It includes non-specific urticaria, aphtoids lesions, but also acrosyndromes, in particular suggestive of chilblains. Pathological findings showed thrombocytic lymphocytic vasculitis. Chilblains are sometimes associated with Raynaud's phenomenon or acrocyanosis. Dermatological features may present pathophysiological similarities with the inflammatory and respiratory vascular disturbances, which makes all the gravity of this disease, or even with other organs. Indeed, genetic conditions such as familial lupus chilblains, linked to a mutation of TREX1 gene, and SAVI (Sting associated vasculopathy with onset on infancy) have similar clinical presentations. In particular, SAVI associates both acral skin and lung damage, and auto-antibodies. They have recently been identified as type I interferonopathies. Hallmark is interferon signature, i.e. hyperexpression of type I interferon in the blood.
The investigators hypothesize Covid-19 may lead to similar skin involvement as in type I interferonopathies. The interferon pathway is involved in anti-viral defense. Covid-19 could cause excessive activation of this pathway. In addition, hyperactivation of the type I interferon pathway leads to modulation of the adaptive immune response. Production of autoantibodies, in particular antiphospholipid antibodies, have thrombogenic properties. Searching for acquired hemostasis disorders and high level of interferon secondary Covid-19 virus infection, could explain this new and misunderstood skin disorder. Then, targeted therapies, both treating and preventing, could be considered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen in Covid unity in Montpellier University Hospital
Key inclusion criteria (1 listed)
- Chilblains or vascular abnormalities (Raynaud's phenomenon, purpura, livedo, necrosis, acrocyanosis) of the acral skin (hands, feet, nose, ears) developping during or after a proved or suspected Covid-19 infection.
Key exclusion criteria (1 listed)
- None
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
Biological acquired thrombophilia
Time frame: 1 day
Searching for presence or absence of abnormal acquired thrombophilic condition as antibodies, hemostasis disturbances. Presence or absence of thrombophilic markers in the blood
1 secondary outcome
Overexpression of interferon type I
Time frame: 1 day
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 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Didier BESSIS, PhD principal investigator
University Hospitals of Montpellier
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 COVID 19, run by University Hospital, Montpellier 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 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 29 Dec 2020. 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?
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?
Biological acquired thrombophilia (time frame: 1 day). 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 29 Dec 2020.