EUCTR2020-001357-52-ES
Active, not recruiting
Phase 1
Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacyand Safety of Chemoprophylaxis With Hydroxychloroquine in Patients UnderBiological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2Infection. COVID-19
IDIVA0 sites800 target enrollmentMay 14, 2020
ConditionsQuimioprophylaxis of SARS-CoV-2 infection with hydroxyloquine (HCQ) in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitorMedDRA version: 20.0Level: HLTClassification code 10021982Term: Inflammatory disorders following infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
Drugshydroxychloroquine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Quimioprophylaxis of SARS-CoV-2 infection with hydroxyloquine (HCQ) in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitor
- Sponsor
- IDIVA
- Enrollment
- 800
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients between 18 and 75 years old at baseline
- •2\) Subjects must be able and willing to give written informed consent
- •and to comply with the requirements of this study protocol
- •3\) Patient in treatment with biological agents in a stable way, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacitinib, baricitinib.
- •4\) Diagnosis of inflammatory bowel disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 600
- •F.1\.3 Elderly (\>\=65 years) yes
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 untreated immunological, endocrine, hematological, 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.
Outcomes
Primary Outcomes
Not specified
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