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Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361786
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
Lyon Civil Hospitals - Lyon Sud Hospital Center
Marseille University Hospital - Assistance-Publique Hôpitaux de Marseille.
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.


Condition or disease
COVID 19

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection: Search for Acquired Thrombophilia and Interferon-alpha Signature
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 30, 2020





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overexpression of interferon type I [ Time Frame: 1 day ]
    Dosing transcriptomic interferon signature in a blood sample. Presence or absence of interferon in the blood


Biospecimen Retention:   Samples Without DNA
Blood and skin biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in Covid unity in Montpellier University Hospital
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361786


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Lyon Civil Hospitals - Lyon Sud Hospital Center
Marseille University Hospital - Assistance-Publique Hôpitaux de Marseille.
Investigators
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Principal Investigator: Didier BESSIS, PhD University Hospitals of Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04361786    
Other Study ID Numbers: RECHMPL20_0211
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Suspected or proved Covid-19 virus infection, current or past
Chilblains
Interferon
Vasculitis
Additional relevant MeSH terms:
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Infection