COVID-19ACROVIDNCT04387955
Analysis of Chilblains pROfile During coVID-19 Epidemic (ACROVID)
A study testing Biological Sample Collection in people with COVID-19 and Chilblains, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Chilblains
- What is being tested?
- Biological Sample Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Chilblains Profile During COVID-19 Epidemic
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.
- Conditions
- COVID-19, Chilblains
- Being tested
- Biological Sample Collection
- Medical subject headings
- COVID-19, Chilblains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Sample CollectionDiagnostic test
- Diagnostic test : biological sample collection at Day 0
- Two skin biopsies on chilblain at Day 0 (one biopsy for histological analysis, one biopsy for basic research)
- Anal swabbing at Day 0
- Blood test at Day 0
- Blood test at Month 1
- Blood test at Month 2
| Study group | Role | What they receive |
|---|---|---|
| Acrovid | Other | Cohort Receives: Diagnostic Test: Biological Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics.
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 :
- SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) on a positive nasopharyngeal swab pre-inclusion.
- And/or RT-PCR SARS-CoV-2 on positive anal swab at D0
- And/or RT-PCR SARS-CoV-2 on skin bubble fluid positive at D0.
- And/or RT-PCR SARS-CoV-2 on skin biopsy positive at D0.
- And/or SARS-CoV-2 serology positive at D0 and/or M1 and/or M2.
Measured: 2 months
Secondary outcomes (9)
Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic.
SARS-CoV-2 virological profile of patients with chilblains during a COVID-19 epidemic:
- Proportion of patients with positive SARS-CoV-2 RT-PCR on pre-inclusion nasopharyngeal swab.
- Proportion of patients with a positive RT-PCR SARS-CoV-2 on anal self-sampling at D0 +/- M1.
- Proportion of patients with positive RT-PCR SARS-CoV-2 on skin bubble fluid collection at D0 +/- M1.
- Proportion of patients with positive RT-PCR SARS-CoV-2 on skin biopsy at D0 and viral quantification.
- Proportion of patients with positive SARS-CoV-2 serology at D0 and/or M1 and/or M2.
- Proportion of SARS-CoV-2 positive serum neutralization in patients with SARS-CoV-2 positive serology at D0 and/or M1 and/or M2.
- Proportion of patients with a positive viral culture at sites with positive PCR (nasopharyngeal or anal or bubble fluid or skin biopsy).
Measured: 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).
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 of the clinical signs detailed in the ACROVID data collection sheet in the Appendix.
- Proportions of each of the biological characteristics detailed in the ACROVID data collection form in the Appendix.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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).
Measured: 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).
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
Measured: 2 months
Comparison of the gene expression profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
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.
Measured: 2 months
Comparison of the immunostaining profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
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.
Measured: 2 months
Comparison of the ELISA assays profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start30 Apr 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387955
- Sponsor's protocol ID
- ACROVID
- Acronym
- ACROVID
- Status last verified
- Nov 2021
- First submitted
- 29 Apr 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Chilblains Profile During COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT04387955
- Acronym / sponsor ID
- ACROVID / ACROVID
- Conditions
- COVID-19, Chilblains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort
| Arm | Type | Receives |
|---|---|---|
| Acrovid | Other | Diagnostic Test: Biological Sample CollectionCohort |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological Sample Collection* Diagnostic test : biological sample collection at Day 0 * Two skin biopsies on chilblain at Day 0 (one biopsy for histological analysis, one biopsy for basic research) * Anal swabbing at Day 0 * Blood test at Day 0 * Blood test at Month 1 * Blood test at Month 2 | Diagnostic test | Acrovid |
Primary outcome
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 : * SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) on a positive nasopharyngeal swab pre-inclusion. * And/or RT-PCR SARS-CoV-2 on positive anal swab at D0 * And/or RT-PCR SARS-CoV-2 on skin bubble fluid positive at D0. * And/or RT-PCR SARS-CoV-2 on skin biopsy positive at D0. * And/or SARS-CoV-2 serology positive at D0 and/or M1 and/or M2.
9 secondary outcomes
Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic.
Time frame: 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 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 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 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 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 of the gene expression profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
Time frame: 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 of the ELISA assays profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Sample Collection in people with COVID-19 and Chilblains, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.