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

NCT ID: NCT04330495

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2021-08-27

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.

Conditions

COVID 19; Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Testing and prophylaxis of SARS-CoV-2

Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.

Group Type: EXPERIMENTAL

Hidroxicloroquina

Intervention Type: DRUG

Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.

placebo

Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: DRUG

Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

Interventions

Hidroxicloroquina

Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.

Intervention Type: DRUG

Control group

Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EnCOVID-HidroxiCLOROQUINA

Identifier Type: -

Identifier Source: org_study_id