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 clínical 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months
Incidence rate of new COVID-19 cases in both arms
number of new cases divided by number of persons-time at risk
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 27 weeks after the beginning of the study
Adverse events
Presence and type of adverse events at this point.
Time frame: 12 weeks after the start of treatment
Adverse events
Proportion of participants that drop out of study
Time frame: 27 weeks after the beginning of the study
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