Adult Patients With Lesions on Fingers or ToesACROCOVIDNCT04590209
Clinical and Mechanistic Study of Patients (With COVID-19 or Not) With a Recent Acrosyndrome
A study testing Blood sampling and Skin biopsy in people with Adult Patients With Lesions on Fingers or Toes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients With Lesions on Fingers or Toes
- What is being tested?
- Blood sampling and Skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2023to Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients under guardianship or under curate
- Patients under state medical assistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome
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:
- Determine the possible link with this virus,
- Understand the mechanisms involved in the pathogenesis of these lesions.
Read the 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.
- Being tested
- Blood sampling, Skin biopsy
- Keywords
- SARS-CoV-2, COVID-19, Acrosyndrome, Skin lesions
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
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
Skin biopsyOther
Recruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis
| Study group | Role | What they receive |
|---|---|---|
| Acrosyndrome | Experimental | The blood sample, skin biopsy and other biological samples will be taken from patients
The precise description of the semiology of skin lesions, their topography, as well as the analysis of the entire skin integument and mucous, cardiac and pulmonary auscultation and neurological examination will be done as required. Receives: Other: Blood sampling; Other: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SARS-CoV-2 by real-time PCR and serological test
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)
Measured: assessing change between day 0 and day 15
Secondary outcomes (2)
Detection of SARS-CoV-2 by metagenomics analysis
Metagenomics analysis will be performed on nasopharyngeal, tonsil and perianal samples
Measured: Up to 2.5 months after inclusion
Detection of acrosyndrome by transcriptomic analysis of skin samples
Transcriptomic analysis will be conducted with RNA extracted from frozen skin samples
Measured: Up to 2.5 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startJan 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Abandonment of the study project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Lesions on Fingers or ToesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Cochin, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sélim Aractingi, MD, PhD, Principal investigator, Tarnier Hospital, AP-HPNicolas Dupin, MD, PhD, Study director, Tarnier Hospital, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590209
- Sponsor's protocol ID
- APHP200884
- Other IDs
- N° IDRCB 2020-A0181336
- Acronym
- ACROCOVID
- Status last verified
- Mar 2026
- First submitted
- 5 Oct 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome
- ClinicalTrials.gov ID
- NCT04590209
- Acronym / sponsor ID
- ACROCOVID / APHP200884
- Keywords
- SARS-CoV-2, COVID-19, Acrosyndrome, Skin lesions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Abandonment of the study project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut Cochin, URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Oct 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.
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:
- Determine the possible link with this virus,
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acrosyndrome | Experimental | Other: Blood sampling, Other: Skin biopsyThe blood sample, skin biopsy and other biological samples will be taken from patients The precise description of the semiology of skin lesions, their topography, as well as the analysis of the entire skin integument and mucous, cardiac and pulmonary auscultation and neurological examination will be done as required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under guardianship or under curate
- Patients under state medical assistance
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 |
|---|---|---|
| Blood samplingRecruited 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 | Other | Acrosyndrome |
| Skin biopsyRecruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis | Other | Acrosyndrome |
Primary outcome
Detection of SARS-CoV-2 by real-time PCR and serological test
Time frame: 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)
2 secondary outcomes
Detection of SARS-CoV-2 by metagenomics analysis
Time frame: Up to 2.5 months after inclusion
Detection of acrosyndrome by transcriptomic analysis of skin samples
Time frame: Up to 2.5 months after inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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.
Sélim Aractingi, MD, PhD principal investigator
Tarnier Hospital, AP-HP
Nicolas Dupin, MD, PhD study director
Tarnier Hospital, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and Skin biopsy in people with Adult Patients With Lesions on Fingers or Toes, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 12 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Detection of SARS-CoV-2 by real-time PCR and serological test (time frame: assessing change between day 0 and day 15). 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 12 Mar 2026.