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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001536-98-ES

Enrollment

300

Registered

2020-04-20

Start date

2020-04-18

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection

Interventions

Trade Name: hidroxicloroquine Pharmaceutical Form: Capsule INN or Proposed INN: Hydroxychloroquine CAS Number: 747-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Health professionals with high risk of transmission taking prophylaxis (Group A) and the control group of high risk health professionals who decide not to take it (Group C1) will be compared. 2. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Professionals with high risk of transmission taking prophylaxis (Group A) and the control group of professionals with low risk of transmission (Group C2) will be compared.;Secondary Objective: 1. Incidence of cases of COVID-19 requiring hospitalization in a conventional plant between day 15 and day 30 of inclusion in the study, comparing the three study groups. 3. Duration of symptoms of COVID-19 in those infected with positive PCR between day 15 and day 30 of inclusion in the study, comparing the three study groups. 4. Incidence and severity (hospital admissions, ICU admissions) of COVID cases in the first 15 days after enrollment in the study, comparing the three study groups.;Primary end point(s): 1. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Health professionals with high risk of transmission taking prophylaxis (Group A) and the control group of high risk health professionals who decide not to take it (Group C1) will be compared. 2. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Professionals with high risk of transmission taking prophylaxis (Group A) and the control group of professionals with low risk of transmission (Group C2) will be compared.;Timepoint(s) of evaluation of this end point: Inclusion in the study: A serology of SARS-CoV-2 will be performed before inclusion,. Day 15 from inclusion: the incubation period of a possible infection ends prior to the inc	—

Measure

Time frame

Main Objective: 1. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Health professionals with high risk of transmission taking prophylaxis (Group A) and the control group of high risk health professionals who decide not to take it (Group C1) will be compared. 2. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Professionals with high risk of transmission taking prophylaxis (Group A) and the control group of professionals with low risk of transmission (Group C2) will be compared.;Secondary Objective: 1. Incidence of cases of COVID-19 requiring hospitalization in a conventional plant between day 15 and day 30 of inclusion in the study, comparing the three study groups. 3. Duration of symptoms of COVID-19 in those infected with positive PCR between day 15 and day 30 of inclusion in the study, comparing the three study groups. 4. Incidence and severity (hospital admissions, ICU admissions) of COVID cases in the first 15 days after enrollment in the study, comparing the three study groups.;Primary end point(s): 1. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Health professionals with high risk of transmission taking prophylaxis (Group A) and the control group of high risk health professionals who decide not to take it (Group C1) will be compared. 2. Incidence of symptomatic healthcare professionals with positive PCR between day 15 and day 30 of inclusion in the study. Professionals with high risk of transmission taking prophylaxis (Group A) and the control group of professionals with low risk of transmission (Group C2) will be compared.;Timepoint(s) of evaluation of this end point: Inclusion in the study: A serology of SARS-CoV-2 will be performed before inclusion,. Day 15 from inclusion: the incubation period of a possible infection ends prior to the inc

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Secondary

Measure	Time frame
Secondary end point(s): 1. Incidence of cases of COVID-19 requiring hospitalization in a conventional plant between day 15 and day 30 of inclusion in the study, comparing the three study groups. 3. Duration of symptoms of COVID-19 in those infected with positive PCR between day 15 and day 30 of inclusion in the study, comparing the three study groups. 4. Incidence and severity (hospital admissions, ICU admissions) of COVID cases in the first 15 days after enrollment in the study, comparing the three study groups.;Timepoint(s) of evaluation of this end point: Inclusion in the study: A serology of SARS-CoV-2 will be performed before inclusion,. Day 15 from inclusion: the incubation period of a possible infection ends prior to the inclusion of the study. Events from now on will count for Objectives 1-5. Day 30 from enrollment: end of treatment period and active follow-up. A second SARS-CoV-2 serology will be performed on all professionals. Day 45 from inclusion: end of the study. It will be evaluated if the health personnel have had symptoms of illness within 15 days after the end of the treatment. The appearance of possible adverse effects will be evaluated.	—

Measure

Time frame

Secondary end point(s): 1. Incidence of cases of COVID-19 requiring hospitalization in a conventional plant between day 15 and day 30 of inclusion in the study, comparing the three study groups. 3. Duration of symptoms of COVID-19 in those infected with positive PCR between day 15 and day 30 of inclusion in the study, comparing the three study groups. 4. Incidence and severity (hospital admissions, ICU admissions) of COVID cases in the first 15 days after enrollment in the study, comparing the three study groups.;Timepoint(s) of evaluation of this end point: Inclusion in the study: A serology of SARS-CoV-2 will be performed before inclusion,. Day 15 from inclusion: the incubation period of a possible infection ends prior to the inclusion of the study. Events from now on will count for Objectives 1-5. Day 30 from enrollment: end of treatment period and active follow-up. A second SARS-CoV-2 serology will be performed on all professionals. Day 45 from inclusion: end of the study. It will be evaluated if the health personnel have had symptoms of illness within 15 days after the end of the treatment. The appearance of possible adverse effects will be evaluated.

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Countries

Spain

Contacts

Public ContactINTERNAL MEDICINE DEPARTMENT

HOSPITAL UNIVERSITARI MUTUA TERRASSA

lboix@mutuaterrassa.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026