Skin ManifestationsChilblainCOVIDNCT04344119
Assessment of Chilbains Occuring During Covid-19 Infection
An observational study of Skin Manifestations and COVID, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Skin Manifestations, COVID, Chilblains
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2020to 25 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 90 years
- All sexes
- Child, Adult, Older adult
Study population: All patients with covid infection presenting with skin manifestations
Who may be able to join
- All patients with proven covid infection (using PCR, serum antibody or lung TDM) and presenting at least one cutaneous lesions that occurred during the infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Skin Manifestations Occuring During Covid-19 Infection With a Special Focus on Chilbains
Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. The aim of this project is to better characterize the cutaneous manifestations occurring during Covid-19 infection with a special focus on chilblains. These acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. Understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. This study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the CHU of Nice in covid-19 patients.
- Conditions
- Skin Manifestations, COVID, Chilblains
- Medical subject headings
- Skin Manifestations, Chilblains
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical skin manifestations
Type and description of the skin manifestations with a special focus on patients with chilblains
Measured: 3 months
Secondary outcomes (2)
Histology and biological data
Data on Histology (HE staining and immunofluorescence) and on biology (blood cells counts, CRP and immune profile) will be collected in covid patient with skin manifestation
Measured: 3 months
Non invasive vascular examination
Vascular examination will be performed by Capillaroscopy, laser-doppler or lung TDM if clinically required
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start9 Apr 2020
- Primary completion30 Apr 2021
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ManifestationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344119
- Sponsor's protocol ID
- 20dermatocovid01
- Acronym
- ChilblainCOVID
- Status last verified
- Jun 2026
- First submitted
- 9 Apr 2020
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hubiche T, Cardot-Leccia N, Le Duff F, Seitz-Polski B, Giordana P, Chiaverini C, Giordanengo V, Gonfrier G, Raimondi V, Bausset O, Adjtoutah Z, Garnier M, Burel-Vandenbos F, Dadone-Montaudie B, Fassbender V, Palladini A, Courjon J, Mondain V, Contenti J, Dellamonica J, Leftheriotis G, Passeron T. Clinical, Laboratory, and Interferon-Alpha Response Characteristics of Patients With Chilblain-like Lesions During the COVID-19 Pandemic. JAMA Dermatol. 2021 Feb 1;157(2):202-206. doi: 10.1001/jamadermatol.2020.4324.
PubMed 33237291
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin Manifestations Occuring During Covid-19 Infection With a Special Focus on Chilbains
- ClinicalTrials.gov ID
- NCT04344119
- Acronym / sponsor ID
- ChilblainCOVID / 20dermatocovid01
- Conditions
- Skin Manifestations, COVID, Chilblains
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 14 Apr 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.
Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. The aim of this project is to better characterize the cutaneous manifestations occurring during Covid-19 infection with a special focus on chilblains. These acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. Understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. This study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the CHU of Nice in covid-19 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with covid infection presenting with skin manifestations
Key inclusion criteria (1 listed)
- All patients with proven covid infection (using PCR, serum antibody or lung TDM) and presenting at least one cutaneous lesions that occurred during the infection.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical skin manifestations
Time frame: 3 months
Type and description of the skin manifestations with a special focus on patients with chilblains
2 secondary outcomes
Histology and biological data
Time frame: 3 months
Non invasive vascular examination
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 33237291Hubiche T, Cardot-Leccia N, Le Duff F, Seitz-Polski B, Giordana P, Chiaverini C, Giordanengo V, Gonfrier G, Raimondi V, Bausset O, Adjtoutah Z, Garnier M, Burel-Vandenbos F, Dadone-Montaudie B, Fassbender V, Palladini A, Courjon J, Mondain V, Contenti J, Dellamonica J, Leftheriotis G, Passeron T. Clinical, Laboratory, and Interferon-Alpha Response Characteristics of Patients With Chilblain-like Lesions During the COVID-19 Pandemic. JAMA Dermatol. 2021 Feb 1;157(2):202-206. doi: 10.1001/jamadermatol.2020.4324.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Manifestations and COVID, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia CAILLON (+33492034011, caillon.c@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical skin manifestations (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344119, which also lists 1 linked publication.
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 Jun 2026.