Clinical and Mechanistic Study of Patients (With COVID-19 or Not) With a Recent Acrosyndrome

NCT ID: NCT04590209

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-03-31

Brief Summary

The recent and unexpected occurrence of patients with the development of skin lesions on the hands and/ or feet has been described recently. As these cases occurred contemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the most often occurrence of de novo frostbites, the question raised of whether there is a direct link between the occurrence of these lesions and infection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed, mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorly understood. Therefore, this study aim to:

1. Determine the possible link with this virus,

2. Understand the mechanisms involved in the pathogenesis of these lesions.

Detailed Description

In this study, the investigator designed a prospective interventional study in order to collect blood samples and skin lesion biopsy at significant time points in patients who present a skin lesion. The intervention in this study is limited to some blood samples and skin biopsies.

Two 7 mL tubes of blood will be collected at consultant time for essentially serological test for the SARS-CoV-2 and for analysing certain populations of white blood cells. The second additional blood sample of 7 mL will be collected around day 15 after inclusion in a dry tube to perform a serological test for SARS-CoV-2 at a distance from the onset of skin signs.

A biopsy for histological study is usually done in patients with acrosyndrome. This is why this type of biopsy will be done as a routine care of these patients. An immunohistochemical study could complete the histological explorations using an anti-coronavirus antibody if arguments in favour of SARS-CoV-2 are demonstrated. In this study, patients who accept and sign informed consent will be proposed a skin biopsy on a characteristic lesion for freezing. This biopsy can be used for transcriptomic analysis. This may allow a better understanding of the mechanisms of the disease.

Conditions

Adult Patients With Lesions on Fingers or Toes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Acrosyndrome

The blood sample, skin biopsy and other biological samples will be taken from patients

The precise description of the semiology of skin lesions, their topography, as well as the analysis of the entire skin integument and mucous, cardiac and pulmonary auscultation and neurological examination will be done as required.

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: OTHER

Recruited patients will be subjected to 2 blood samples of 7 mL at day 0 for serological analysis and cell collection and to an additional blood sample of 7 mL at day 15 for serological analysis

Skin biopsy

Intervention Type: OTHER

Recruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis

Interventions

Blood sampling

Recruited patients will be subjected to 2 blood samples of 7 mL at day 0 for serological analysis and cell collection and to an additional blood sample of 7 mL at day 15 for serological analysis

Intervention Type: OTHER

Skin biopsy

Recruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients
• Consultant for the recent occurrence of lesions on the fingers and or toes
• Having signed an informed consent
• Affiliated or entitled to a social security regime

Exclusion Criteria

• Patients under guardianship or under curate
• Patients under state medical assistance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sélim Aractingi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tarnier Hospital, AP-HP

Nicolas Dupin, MD, PhD

Role: STUDY_DIRECTOR

Tarnier Hospital, AP-HP

Locations

Department of Dermatology, Tarnier hospital, AP-HP

Paris, , France

Countries

France

Central Contacts

Sélim Aractingi, MD, PhD

Role: CONTACT

selim.aractingi@aphp.fr

+33158411813

Marie Benhammani-Godard

Role: CONTACT

marie.godard@aphp.fr

00.33158411190

Facility Contacts

Sélim Aractingi, MD, PhD

Role: primary

selim.aractingi@aphp.fr

+33158411813

Other Identifiers

N° IDRCB 2020-A0181336

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200884

Identifier Type: -

Identifier Source: org_study_id