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

March 10, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75006
        • Department of Dermatology, Tarnier hospital, AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: assessing change between day 0 and day 15
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
Time Frame: Up to 2.5 months after inclusion
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
Time Frame: Up to 2.5 months after inclusion
Transcriptomic analysis will be conducted with RNA extracted from frozen skin samples
Up to 2.5 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2023

Primary Completion (Estimated)

March 1, 2023

Study Completion (Estimated)

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)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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