Acral Cutaneous Thrombotic Vasculopathy and Covid-19 Infection

NCT04361786 | Completed

• 1 other identifier: RECHMPL20_0211
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Keywords

Suspected or proved Covid-19 virus infection, current or past; Chilblains; Interferon; Vasculitis

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (1)

• Overexpression of interferon type I

  1 day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in Covid unity in Montpellier University Hospital

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Lyon Civil Hospitals - Lyon Sud Hospital Center: collaborator
• University Hospital, Marseille: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and skin biopsy

MeSH Terms

Conditions

COVID-19; Chilblains; Vasculitis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Frostbite; Cold Injury; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Didier BESSIS, PhD

  University Hospitals of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: April 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)