Study for the prevention of COVID-19 infection in healthcare personnel

Pilot, double-blind clinical trial to evaluate the efficacy and safety of pre-exposure use of hydroxychloroquine versus placebo in the prevention of SARS-CoV-2 (COVID-19) infection in healthcare personnel. - PrevenCOVID-19

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001440-26-ES

Enrollment

184

Registered

2020-04-20

Start date

2020-04-19

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

Prevention of SARS-CoV-2 (COVID-19) infection

Interventions

Trade Name: Dolquine Pharmaceutical Form: Capsule INN or Proposed INN: Hydroxychloroquine CAS Number: 118-42-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthcare personnel (doctor, nurse, nursing assistant or hospital porter) with risk of exposure to SARS-CoV-2 infected or probably infected patients. 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 184 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age under 18. Weight under 40Kg Pregnancy Contraindications for the use of hydroxychloroquine (allergy, retinal disease, myasthenia gravis...)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of hydroxychloroquine preventive administration in healthcare personnel with risk of exposure to COVID-19 infected patients.;Secondary Objective: To assess the safety and tolerability of preventive use of hydroxychloroquine in healthcare personnel.;Primary end point(s): - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group. - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group.;Timepoint(s) of evaluation of this end point: At the end of treatment (day 60)	—

Measure

Time frame

Main Objective: To assess the efficacy of hydroxychloroquine preventive administration in healthcare personnel with risk of exposure to COVID-19 infected patients.;Secondary Objective: To assess the safety and tolerability of preventive use of hydroxychloroquine in healthcare personnel.;Primary end point(s): - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group. - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group.;Timepoint(s) of evaluation of this end point: At the end of treatment (day 60)

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Secondary

Measure	Time frame
Secondary end point(s): - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of the seroconversion rate in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of temporary work disability (TWD) and/or the employee absenteeism at the end of the study from 9% in control group to 5% in experimental group - Safety: presence of adverse events;Timepoint(s) of evaluation of this end point: At the end of treatment (day 60) Safety will be evaluated at day 15, 30 and 60.	—

Measure

Time frame

Secondary end point(s): - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of the seroconversion rate in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of temporary work disability (TWD) and/or the employee absenteeism at the end of the study from 9% in control group to 5% in experimental group - Safety: presence of adverse events;Timepoint(s) of evaluation of this end point: At the end of treatment (day 60) Safety will be evaluated at day 15, 30 and 60.

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Countries

Spain

Contacts

Public ContactClinical trial information

CTU-HUVR

claram.rosso.sspa@juntadeandalucia.es+34670949617

Outcome results

None listed

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