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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

Tracking Information
First Submitted Date  ICMJE March 31, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date April 13, 2020
Estimated Study Start Date  ICMJE April 6, 2020
Estimated Primary Completion Date November 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • Adverse events [ Time Frame: 12 weeks after the start of treatment ]
    Presence and type of adverse events at this point.
  • Adverse events [ Time Frame: 27 weeks after the beginning of the study ]
    Proportion of participants that drop out of study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, controlled, double-blind clinical trial
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID 19
  • Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
Intervention  ICMJE
  • Drug: Hidroxicloroquina
    Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
  • Drug: Control group
    Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months
Study Arms  ICMJE
  • Experimental: Testing and prophylaxis of SARS-CoV-2
    Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
    Intervention: Drug: Hidroxicloroquina
  • Active Comparator: placebo
    Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months
    Intervention: Drug: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2020)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 6, 2020
Estimated Primary Completion Date November 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Javier Crespo, MDPhD 942202520 javiercrespo1991@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04330495
Other Study ID Numbers  ICMJE EnCOVID-HidroxiCLOROQUINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Instituto de Investigación Marqués de Valdecilla
Study Sponsor  ICMJE Instituto de Investigación Marqués de Valdecilla
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto de Investigación Marqués de Valdecilla
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP