COVID-19
Conditions
Keywords
lupus erythematous disease, prophylaxis, pre-emptive therapy, Hydroxy-Chloroquine
Brief summary
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.
Detailed description
A pre- or post-exposure treatment strategy has been validated in some infectious diseases. In particular, in HIV infection, this type of prophylactic treatment reduces the rate of infection in at-risk populations. The first studies from Chinese show that in case of immunosuppression or immunosuppressive treatment, whatever the causal pathology, COVID-19 infection is more severe. The present study presents a population of patients with lupus (SLE) or Gougerot's disease (SGD) who are treated for a long time, with Hydroxy-Chloroquine. The protective effect against COVID-19 infection of Hydroxy-Chloroquine compared to populations not exposed to this drug requires to be assessed in patients and their control groups under or without immunosuppressive treatments. It is hypothesized that long-term treatment with Hydroxy-Chloroquine in SLE or SGD taken in its usual indication before the onset of the pandemic could decrease the number of COVID19 infections and/or the intensity of the disease.
Interventions
DIAGNOSTIC_TESTCOVID 19 serology
Diagnosis of Covid-19 past infection will be made by serology
OTHERCOVID 19 Self-Questionnaire
COVID 19 Self-Questionnaire
Sponsors
University Hospital, Toulouse
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group with hydroxychloroquine treatment (HC +): * LED/SG diagnosed * Treatment with Hydroxy-Chloroquine in the 3 months before and during the outbreak at COVID 19, at least in December 2019. Patients may have treatment with immunosuppressants in combination with Hydroxy-Chloroquine. * COVID19 diagnostic questionnaire and available serology result. Group without hydroxychloroquine treatment (HC-) : * No Hydroxy-Chloroquine intake for more than 12 months --\> HC- without an immunosuppressant * Viral hepatitis C cured for more than 12 months or primitive bile cholangitis (CBP) whose diagnosis is based on international criteria. * Non-significant liver fibrosis assessed either by historical histology or by fibroscan with non-significant liver fibrosis Metavir - F3 (at last available examination) * No Hydroxy-Chloroquine, or immunosuppressants have been taken for more than 12 months. * COVID19 diagnostic questionnaire and COVID19 serology result available. --\>HC- with an immunosuppressant * Diagnosis of LED/SG according to the CAB criteria revised in 1997 or autoimmune hepatitis according to the international criteria validated in 2008. * Patients treated with immunosuppressants for at least three months before the start of the pandemic at COVID 19, at least since December 2019. * COVID19 diagnostic questionnaire and available serology result.
Exclusion criteria
* Anti-CD20 or Cyclophosphamide taken during the six months prior to the completion of the COVID 19 serology. * Refusal of a blood test for antibodies to COVID-19. * Protected adults * Pregnant or breastfeeding women. * Lack of health insurance coverage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Anti-SARS-CoV-2 Serology | 12 months post inclusion | Number of patients with positive anti-COVID19 serology depending on whether or not they were taking Hydroxy-Chloroquine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced Symptomatic or Severe (Hospitalization) COVID-19 Infection | From inclusion until the end of the study (at M12) | Percentage of patients who experienced symptomatic or severe (hospitalization) COVID-19 infection, as determined by the self-administered questionnaire and medical consultation. Each subject will complete a self-administered questionnaire at the enrollment visit, describing the main symptoms of COVID-19 infection by answering "yes" or "no" to the various items. The physician will then conduct a medical assessment of the symptoms and their severity. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLaurent ALRIC, Pr
University Hospital, Toulouse
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.95 Years STANDARD_DEVIATION 19.17 |
| Polymedicated patient | 71 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 121 | 0 / 115 | 0 / 199 |
| other Total, other adverse events | 0 / 112 | 0 / 121 | 0 / 115 | 0 / 199 |
| serious Total, serious adverse events | 0 / 112 | 0 / 121 | 0 / 115 | 0 / 199 |
Outcome results
None listed