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

Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adult Patients With Lesions on Fingers or Toes
• Intervention / Treatment: Other: Blood sampling; Other: Skin biopsy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sélim Aractingi, MD, PhD; Phone Number: +33158411813; Email: selim.aractingi@aphp.fr
• Study Contact Backup: Name: Marie Benhammani-Godard; Phone Number: 00.33158411190; Email: marie.godard@aphp.fr

Study Locations

• France
  • Paris, France, 75006
    • Department of Dermatology, Tarnier hospital, AP-HP
    • Contact: Sélim Aractingi, MD, PhD; Phone Number: +33158411813; Email: selim.aractingi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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; Other: Skin biopsy; Recruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of SARS-CoV-2 by metagenomics analysis	Metagenomics analysis will be performed on nasopharyngeal, tonsil and perianal samples	Up to 2.5 months after inclusion
Detection of acrosyndrome by transcriptomic analysis of skin samples	Transcriptomic analysis will be conducted with RNA extracted from frozen skin samples	Up to 2.5 months after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut Cochin
• Investigators: Principal Investigator: Sélim Aractingi, MD, PhD, Tarnier Hospital, AP-HP; Study Director: Nicolas Dupin, MD, PhD, Tarnier Hospital, AP-HP

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Acrosyndrome; Skin lesions
• Other Study ID Numbers: APHP200884; N° IDRCB 2020-A0181336 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No