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The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clÃnical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points.
Drug interventions in this protocol will follow the Spanish law about off-label use of medicines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing and prophylaxis of SARS-CoV-2 | Experimental | Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months. |
|
| placebo | Active Comparator | Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hidroxicloroquina | Drug | Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of new COVID-19 cases in both arms | number of new cases divided by number of persons-time at risk | From day 14 after start of treatment up to the end of follow-up: week 27 |
| Prevalence of COVID-19 cases in both arms | percentage of cases of COVID 19 | 27 weeks after the beginning of the study |
| Mortality rate secondary to COVID-19 cases in both groups | Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death | 27 weeks after the beginning of the study |
| Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups | percentage of patients who need admission in an ICU due to COVID 19 infection | 27 weeks after the beginning of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Presence and type of adverse events at this point. | 12 weeks after the start of treatment |
| Adverse events | Proportion of participants that drop out of study |
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Inclusion Criteria:
Exclusion Criteria
to. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).
b. Total bilirubin> 25 μmol / l (1.5 mg / dl). c. International normalized index> 1.4. d. Platelet count <100,000 / mm3. 17. Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 24 mg / dl) in women.
18.Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the measurement of eGFR may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.Pregnant or lactating women; 19. Inability to consent and/or comply with study protocol; 20. Individuals with known hypersensitivity to the study drugs. 21. Any contraindications as per the Data Sheet of or Hydroxychloroquine.
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Randomized, controlled, double-blind clinical trial
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| Control group | Drug | Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months |
|
| 27 weeks after the beginning of the study |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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