Clinical trial NCT04590209: Clinical and Mechanistic Study of Patients (With COVID-19 or Not) With a Recent Acrosyndrome
Official title: Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult Patients With Lesions on Fingers or Toes
Keywords: SARS-CoV-2
COVID-19
Acrosyndrome
Skin lesions
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut Cochin
First posted: 2020-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Detection of SARS-CoV-2 by real-time PCR and serological test
timeFrame: assessing change between day 0 and day 15
Secondary outcomes:
measure: Detection of SARS-CoV-2 by metagenomics analysis
timeFrame: Up to 2.5 months after inclusion
measure: Detection of acrosyndrome by transcriptomic analysis of skin samples
timeFrame: Up to 2.5 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Dermatology, Tarnier hospital, AP-HP
Study officials:
affiliation: Tarnier Hospital, AP-HP
name: Sélim Aractingi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarnier Hospital, AP-HP
name: Nicolas Dupin, MD, PhD
role: STUDY_DIRECTOR
References: