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

Adult Patients With Lesions on Fingers or Toes Clinical Trial

— ACROCOVID  

Official title:

Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04590209
• Other study ID #: APHP200884
• Secondary ID: N° IDRCB 2020-A0
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: March 2023

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sélim Aractingi, MD, PhD
• Phone: +33158411813
• Email: selim.aractingi[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Patients With Lesions on Fingers or Toes

Intervention

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

Locations

Country	Name	City	State
France	Department of Dermatology, Tarnier hospital, AP-HP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut Cochin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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