Covid 19 Research using Clinical Trials (Home Page)
Report for D002647: Chilblains NIH
(Synonyms: Chilblains)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug745 | Detection of anti-COVID-19 antibody level Wiki | 0.58 |
| drug747 | Device used to record voice for screening Wiki | 0.58 |
| drug346 | Biological Sample Collection Wiki | 0.58 |
| drug349 | Biological sample collection Wiki | 0.41 |
| drug748 | Dexamethasone Wiki | 0.33 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 3 clinical trials
Clinical Trials
1 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.
NCT04344119 Skin Manifestations COVID Chilblains MeSH:Skin Manifestations Chilblains
Primary Outcomes
Description: Type and description of the skin manifestations with a special focus on patients with chilblains
Measure: Clinical skin manifestations Time: 3 monthsSecondary Outcomes
Description: 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
Measure: Histology and biological data Time: 3 monthsDescription: Vascular examination will be performed by Capillaroscopy, laser-doppler or lung TDM if clinically required
Measure: Non invasive vascular examination Time: 3 months2 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.
NCT04387955 COVID-19 Chilblains Diagnostic Test: Biological Sample Collection MeSH:Chilblains
Primary Outcomes
Description: 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 TranscriptionâPolymerase 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.
Measure: Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics. Time: 2 monthsSecondary Outcomes
Description: 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).
Measure: Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic. Time: 2 monthsDescription: 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.
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). Time: 2 monthsDescription: 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.
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). Time: 2 monthsDescription: 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.
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). Time: 2 monthsDescription: 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).
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). Time: 2 monthsDescription: 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
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). Time: 2 monthsDescription: 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.
Measure: Comparison of the gene expression profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects. Time: 2 monthsDescription: 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.
Measure: Comparison of the immunostaining profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects. Time: 2 monthsDescription: 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.
Measure: Comparison of the ELISA assays profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects. Time: 2 months3 Chilblains, COVID-19 and Lockdown: Epidemiologic Study
Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual frequency during the confinement period, most commonly in children, teenagers and young adults. The aim of the ECCES study is to find out whether these manifestations of chilblains can be linked to the SARS-CoV-2 coronavirus. For this, an epidemiologic study will compare two types of family (or more precisely people who were confined together in March-April-May): - "case family" in which at least one of the members had chilblains - "comparator family" in which none of the members had chilblains Environment (home lockdown) of the two types of family will be analyzed. Each member of the "family" will be suggested doing a serological test.
NCT04455308 Chilblains COVID-19 Diagnostic Test: Biological sample collection MeSH:Chilblains
Primary Outcomes
Measure: Level of viral exposure in "case family" compared to "comparator family" Time: Through study completion, an average of 3 monthsSecondary Outcomes
Measure: Comparison of seropositivity rates in subjects with chilblains and their age-matched controls Time: Through study completion, an average of 3 monthsMeasure: Comparison of SARS-CoV-2 seropositivity rates among members of case (subject with chilblains) and control (subject without chilblains) outbreaks Time: Through study completion, an average of 3 months
Measure: Antibody avidity and differentiated IgG and IgM assay by subject in the homes Time: Through study completion, an average of 3 months