Clinical trial NCT04387955: Analysis of Chilblains pROfile During coVID-19 Epidemic (ACROVID)
Official title: Analysis of Chilblains Profile During COVID-19 Epidemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Chilblains
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort
Primary purpose: DIAGNOSTIC

Brief summary: Cases of chilblains have been reported with an unusual frequency in France in the context of the COronaVirus Infectious Disease 2019 (COVID-19) epidemic. Some of these cases have been linked to a virological status in favour of a recent Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. Chilblains are acral inflammatory lesion typically reactive to cold (primary form). There are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type I Interferonopathy. An interferon type I signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of CoV-2 SARS infection. If cases of frostbite are indeed secondary to an SARS-CoV-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during COVID-19.


Eligibility criteria: Inclusion Criteria:

* Patient over the age of majority or a minor over 12 years of age accompanied by his/her legal representative
* Benefiting from a Social Security scheme
* Informed consent signed by the patient (if major) or by his legal representative (if minor) after clear, fair and appropriate information about the study.
* Red and swollen lesions of the hands and/or feet evolving for more than 24 hours in the context of a COVID-19 epidemic.
* PCR SARS-CoV-2 PCR on nasopharyngeal swab with results available, prior to the inclusion visit.
* Absence of fever or respiratory signs suggestive of COVID-19 for at least 14 days

Exclusion Criteria:

* A person who does not benefit from a Social Security scheme or who does not benefit from it through a third party.
* Patient who is subject to a judicial safeguard measure
* Allergy to local anaesthetic products
* Fever or respiratory signs suggestive of COVID-19 within 14 days

Primary outcomes:
measure: Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics.
timeFrame: 2 months
Secondary outcomes:
measure: Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic.
timeFrame: 2 months
measure: Comparison of the clinical and biological profiles of patients presenting chilblains according to their SARS-CoV-2 virological status (in case of over-representation of SARS-CoV-2 positive patients, the results will be given without comparison).
timeFrame: 2 months
measure: Comparison of the capillaroscopic profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).
timeFrame: 2 months
measure: Comparison of the TCPO2 profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).
timeFrame: 2 months
measure: Comparison of the toe or Finger Pressure Index profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).
timeFrame: 2 months
measure: Comparison of histo-pathological profiles of chilblains according to their SARS-CoV-2 virological status of patients with the disease (in case of overrepresentation of SARS-CoV-2 positive patients, results will be given without comparison).
timeFrame: 2 months
measure: Comparison of the gene expression profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
timeFrame: 2 months
measure: Comparison of the immunostaining profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
timeFrame: 2 months
measure: Comparison of the ELISA assays profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
timeFrame: 2 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: