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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

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ClinicalTrials.gov Identifier: NCT04330495
Recruitment Status : Not yet recruiting
First Posted : April 1, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Marqués de Valdecilla

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.


Condition or disease Intervention/treatment Phase
COVID 19 Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors Drug: Hidroxicloroquina Drug: Control group Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, double-blind clinical trial
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : April 6, 2020
Estimated Primary Completion Date : November 6, 2020
Estimated Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Testing and prophylaxis of SARS-CoV-2
Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
Drug: Hidroxicloroquina
Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.

Active Comparator: placebo
Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months
Drug: Control group
Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months




Primary Outcome Measures :
  1. 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

  2. Prevalence of COVID-19 cases in both arms [ Time Frame: 27 weeks after the beginning of the study ]
    percentage of cases of COVID 19

  3. 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

  4. 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 Outcome Measures :
  1. Adverse events [ Time Frame: 12 weeks after the start of treatment ]
    Presence and type of adverse events at this point.

  2. Adverse events [ Time Frame: 27 weeks after the beginning of the study ]
    Proportion of participants that drop out of study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
  2. Aged ≥18 and < 75 years male or female;
  3. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
  4. Willing to take study medication
  5. Willing to comply with all study procedures,
  6. Diagnosis of IBD disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.
  7. 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
  8. Able to provide oral and written informed consent

Exclusion Criteria

  1. Previous infection with SARS-CoV-2.
  2. Current treatment with hydroxychloroquine / chloroquine.
  3. Previous or current treatment with tamoxifen or raloxifene.
  4. Previous eye disease, especially maculopathy.
  5. Known heart failure grade III-IV of the classification of the New York Heart Association).
  6. Any type of cancer (except basal cell) in the last 5 years.
  7. Pregnancy.
  8. Refusal to give informed consent.
  9. Evidence of any other unstable or clinically significant unstable, clinically significant, immunological, endocrine, hematologic, gastrointestinal, neurological, neoplastic, or psychiatric illness.
  10. Instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.
  11. Positive antibodies to the human immunodeficiency virus.
  12. 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.

18.Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the measurement of eGFR may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.Pregnant or lactating women; 19. Inability to consent and/or comply with study protocol; 20. Individuals with known hypersensitivity to the study drugs. 21. Any contraindications as per the Data Sheet of or Hydroxychloroquine.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330495


Contacts
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Contact: Javier Crespo, MDPhD 942202520 javiercrespo1991@gmail.com

Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
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Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT04330495    
Other Study ID Numbers: EnCOVID-HidroxiCLOROQUINA
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents