Adult Patients With Lesions on Fingers or Toes
Conditions
Keywords
SARS-CoV-2, COVID-19, Acrosyndrome, Skin lesions
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.
Interventions
OTHERBlood 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
OTHERSkin biopsy
Recruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis
Sponsors
Assistance Publique - Hôpitaux de Paris
Institut Cochin
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of SARS-CoV-2 by real-time PCR and serological test | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of acrosyndrome by transcriptomic analysis of skin samples | Up to 2.5 months after inclusion | Transcriptomic analysis will be conducted with RNA extracted from frozen skin samples |
| Detection of SARS-CoV-2 by metagenomics analysis | Up to 2.5 months after inclusion | Metagenomics analysis will be performed on nasopharyngeal, tonsil and perianal samples |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSélim Aractingi, MD, PhD
Tarnier Hospital, AP-HP
STUDY_DIRECTORNicolas Dupin, MD, PhD
Tarnier Hospital, AP-HP
Outcome results
None listed