Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection
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|ClinicalTrials.gov Identifier: NCT04361786|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : July 29, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|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|
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361786
|Montpellier, France, 34295|
|Principal Investigator:||Didier BESSIS, PhD||University Hospitals of Montpellier|