Effect of the administration of Hydroxychloroquine as prevention of COVID-19 infection in patients with biological treatment or with JAK inhibitors

Phase 1

• 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; MedDRA version: 20.0Level: HLTClassification code 10021982Term: Inflammatory disorders following infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001357-52-ES
• Lead Sponsor: IDIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-14
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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
F.1.3.1 Number of subjects for this age range 200

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.
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.
13) Serum creatinine levels> 135 µmol / l (> 1.53 mg / dl) in men and> 110 µmol / l (> 1.24 mg / dl) in women.
14) 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 eGFR measurement 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified