Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04361786
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-04-17
Brief Title:
Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection Search for Acquired Thrombophilia and Interferon-alpha Signature
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Raynauds 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 ie 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None