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Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection

COVID 19 Clinical Trial

Official title:
Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • COVID 19
  • COVID-19
  • Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
Clinical Trial Details
NCT number NCT04330495
Study type Interventional
Source Instituto de Investigación Marqués de Valdecilla
Contact
Status Withdrawn
Phase Phase 4
Start date April 6, 2020
Completion date August 27, 2021
View Details
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