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

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.

Timeline

Start

2020-04-06

Primary completion

2020-11-06

Completion

2021-08-27

Outcome

Outcome not reported

Stopped: “* Care pressures on the investigator team during the COVID-19 pandemic. * Subsequent appearance of scientific evidence on the lack of efficacy of hydroxychloroquine in the treatment or prophylaxis of COVID-19 infection.”

Drugs

Indications