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

NCT04590209 | Withdrawn

• 2 other identifiers: APHP200884N° IDRCB 2020-A0181336
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.Determine the possible link with this virus,
2. 2.Understand the mechanisms involved in the pathogenesis of these lesions.

Conditions

Adult Patients With Lesions on Fingers or Toes

Keywords

SARS-CoV-2; COVID-19; Acrosyndrome; Skin lesions

Outcome Measures

Primary Outcomes (1)

• Detection of SARS-CoV-2 by real-time PCR and serological test

  SARS-CoV-2 will be tested by Polymorphism Chain Reaction (PCR) (on the first day of consultation) and serological analysis ( at day 0 and day 15 after the first consultation)

  assessing change between day 0 and day 15

Secondary Outcomes (2)

• Detection of SARS-CoV-2 by metagenomics analysis

  Up to 2.5 months after inclusion

• Detection of acrosyndrome by transcriptomic analysis of skin samples

  Up to 2.5 months after inclusion

Study Arms (1)

Acrosyndrome

EXPERIMENTAL

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.

Other: Blood sampling; Other: Skin biopsy

Interventions

Blood sampling 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

Acrosyndrome

Skin biopsy OTHER

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

Acrosyndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut Cochin: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Department of Dermatology, Tarnier hospital, AP-HP

Paris, 75006, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sélim Aractingi, MD, PhD

  Tarnier Hospital, AP-HP

  PRINCIPAL INVESTIGATOR

• Nicolas Dupin, MD, PhD

  Tarnier Hospital, AP-HP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)