Prophylaxis of COVID-19 infection with hydroxychloroquine in healthcarepersonnel with high risk of infection.

Phase 1

• Conditions: COVID-19 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001536-98-ES
• Lead Sponsor: HOSPITAL UNIVERSITARI MÚTUA TERRASSA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Be over 18 years old and sign the informed consent.
-Not having previously presented or at the time of inclusion SARS-CoV-2
infection.
- In the case of fertile women, a written commitment to use a reliable
contraceptive method for the duration of the study and for 3 months
after the end of treatment.
- Sign the informed consent.
-Groups of patients:
1. Active treatment group (Group A): healthcare professionals with high
risk of exposure to patients with COVID-19 (ICU staff, emergency
departments, medical plants that have patients with COVID-19
hospitalized) who agree to take treatment with hydroxychloroquine. for
a month.
2. Control group 1 (Group C1): health professionals with high risk of
exposure to patients with COVID-19 (ICU staff, emergency departments,
medical plants that have patients with COVID-19 hospitalized) who do
not want to take treatment with hydroxychloroquine for one month.
3. Control group 2 (Group C2): health professionals with low risk of
exposure to patients with COVID.
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 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Group A:
- Pregnant or lactating women.
- Having previously had a positive PCR for SARS-CoV-2, presenting
positive serologies for SARS-CoV-2 or compatible clinic at the time of
inclusion.
- Long QT syndrome
- Diseases of the retina or cornea
- Glomerular filtration <30ml / min
- Severe liver dysfunction (Child Pugh 3)
- Hypersensitivity to study medication
- Greater drug interaction between your chronic medication and
hydroxychloroquine.
- Any other contraindication included in the technical sheet of the study
medication

Study & Design

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