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

NCT04330495 | Withdrawn Phase 4

• 1 other identifier: EnCOVID-HidroxiCLOROQUINA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID 19; Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Adverse events

  12 weeks after the start of treatment

• Adverse events

  27 weeks after the beginning of the study

Study Arms (2)

Testing and prophylaxis of SARS-CoV-2

EXPERIMENTAL

Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.

Drug: Hidroxicloroquina

placebo

ACTIVE COMPARATOR

Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

Drug: Control group

Interventions

Hidroxicloroquina DRUG

Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.

Testing and prophylaxis of SARS-CoV-2

Control group DRUG

Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous infection with SARS-CoV-2.
• Current treatment with hydroxychloroquine / chloroquine.
• Previous or current treatment with tamoxifen or raloxifene.
• Previous eye disease, especially maculopathy.
• Known heart failure grade III-IV of the classification of the New York Heart Association).
• Any type of cancer (except basal cell) in the last 5 years.
• Pregnancy.
• Refusal to give informed consent.
• Evidence of any other unstable or clinically significant unstable, clinically significant, immunological, endocrine, hematologic, gastrointestinal, neurological, neoplastic, or psychiatric illness.
• Instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.
• Positive antibodies to the human immunodeficiency virus.
• Data on decompensated liver disease:
• 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.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, double-blind clinical trial

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 1, 2020
• Study Start: April 6, 2020
• Primary Completion: November 6, 2020
• Study Completion: August 27, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09