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
Overview
- Phase
- Phase 4
- Intervention
- Hidroxicloroquina
- Conditions
- COVID 19
- Sponsor
- Instituto de Investigación Marqués de Valdecilla
- Primary Endpoint
- Incidence rate of new COVID-19 cases in both arms
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
- •Aged ≥18 and \< 75 years male or female;
- •In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
- •Willing to take study medication
- •Willing to comply with all study procedures,
- •Diagnosis of IBD disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.
- •Be on stable treatment with biological agents, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacit
- •Able to provide oral and written informed consent
- •Exclusion Criteria
- •Previous infection with SARS-CoV-
Exclusion Criteria
- Not provided
Arms & Interventions
Testing and prophylaxis of SARS-CoV-2
Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
Intervention: Hidroxicloroquina
placebo
Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months
Intervention: Control group
Outcomes
Primary Outcomes
Incidence rate of new COVID-19 cases in both arms
Time Frame: From day 14 after start of treatment up to the end of follow-up: week 27
number of new cases divided by number of persons-time at risk
Prevalence of COVID-19 cases in both arms
Time Frame: 27 weeks after the beginning of the study
percentage of cases of COVID 19
Mortality rate secondary to COVID-19 cases in both groups
Time Frame: 27 weeks after the beginning of the study
Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death
Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups
Time Frame: 27 weeks after the beginning of the study
percentage of patients who need admission in an ICU due to COVID 19 infection
Secondary Outcomes
- Adverse events(27 weeks after the beginning of the study)