- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04387955
Analysis of Chilblains pROfile During coVID-19 Epidemic (ACROVID) (ACROVID)
Analysis of Chilblains Profile During COVID-19 Epidemic
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poitiers, France, 86000
- Chu de Poitiers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Acrovid
Cohort
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics.
Time Frame: 2 months
|
Main Judgement Criterion Comparison between the proportion of patients with chilblains presenting a SARS-CoV-2 positive virological status and the estimated proportion of SARS-CoV-2 positive virological status in the general population. The SARS-CoV-2 positive virological status of patients with chilblains will be defined by :
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic.
Time Frame: 2 months
|
SARS-CoV-2 virological profile of patients with chilblains during a COVID-19 epidemic:
|
2 months
|
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).
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status (if there is an overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison):
|
2 months
|
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).
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status (if there is an overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison): - Proportions of each capillaroscopic abnormalities detailed in the ACROVID data collection sheet in the Appendix present during video capillaroscopy performed on all patient fingers (excluding thumbs) at D0 and M2. |
2 months
|
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).
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status (if there is an overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison): - Measurements of TCPO2 (expressed in mmHg) on the inter-metatarsal or metacarpal space of the two most affected toes or fingers. |
2 months
|
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).
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status (if there is an overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison): - Measurements of the toe or finger pressure index calculated as the ratio of the systolic toe or finger pressure measured on the most affected toe or finger (expressed in mmHg) and the average of the humeral systolic arterial pressure (SAP) measured per cuff on both arms (expressed in mmHg). |
2 months
|
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).
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status (if there is an overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison): - Proportions of the histological characteristics of skin lesions detailed in the ACROVID data collection form in Appendix COVID-19 |
2 months
|
Comparison of the gene expression profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status and healthy subjects : - Levels of messenger RiboNucleic Acid (mRNA) expression encoding cytokines, chemokines and interferon-induced genes involved in anti-viral response and inflammation in chilblains and Peripheral Blood Mononuclear Cell (PBMC) cultures. |
2 months
|
Comparison of the immunostaining profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status and healthy subjects : - Immunostaining profiles (qualitative) of cytokines, chemokines and interferon-induced proteins involved in anti-viral response and inflammation in chilblains biopsy sections. |
2 months
|
Comparison of the ELISA assays profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
Time Frame: 2 months
|
Comparison between patients with chilblains with a positive SARS-CoV-2 status and patients with chilblains with a negative SARS-CoV-2 status and healthy subjects : - ELISA assays of cytokines and chemokines involved in anti-viral response and inflammation in plasma and PBMC supernatant from patients with chilblains. |
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACROVID
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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