Status:
WITHDRAWN
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
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Conditions:
COVID 19
Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 followi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion Criteria
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04330495
Start Date
April 6 2020
End Date
August 27 2021
Last Update
September 16 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.