Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic

Phase 3

Completed

• Conditions: COVID-19
• Interventions: Drug: Placebos; Drug: Hydroxychloroquine

• Registration Number: NCT04331834
• Lead Sponsor: Barcelona Institute for Global Health

Brief Summary

The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-04-03
• Primary Completion: 2020-06-25
• Study Completion: 2020-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Age ≥ 18 years
• Negative PCR and negative serology on day 0
• Healthcare worker at any of the trial sites
• Female participants: negative for pregnancy test
• Willing to participate in the study
• Able to sign the informed consent form

Exclusion Criteria

• Age <18 years

• Pregnancy or breastfeeding

• Ongoing antiviral or antiretroviral treatment or HIV positive

• Ongoing anti-inflammatory treatment (corticosteroids)

• Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment

• Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0

• Positive serology for SARS-CoV-1 infection at day 0

• Impossibility of signing the informed consent form

• Rejection of participation

• Working less than 3 days a week in the Hospital Clinic of Barcelona.

• Any contraindication for hydroxychloroquine treatment:

  • Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
  • Retinopathy, visual field or visual acuity disturbances
  • QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history
  • Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test
  • Previous myocardial infarction
  • Myasthenia gravis
  • Porphyria
  • Glomerular clearance < 10ml/min
  • Previous history of severe hypoglycaemia
  • Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group with placebo	Placebos	Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
Pre-exposure prophylaxis of SARS-CoV-2	Hydroxychloroquine	Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months

Primary Outcome Measures

Name	Time	Method
Confirmed cases of a COVID-19	Up to 6 months after start of treatment	Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.

Secondary Outcome Measures

Name	Time	Method
Occurrence of any adverse event related with hydroxychloroquine treatment	Up to 6 months after start of treatment	Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.
Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19	Up to 6 months after start of treatment
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers	Up to 6 months after start of treatment	Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.
SARS-CoV-2 seroconversion	Up to 6 months after start of treatment	SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.
COVID-19 Biobank	Up to 6 months after start of treatment	A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.

Trial Locations

Locations (1)

ISGlobal; 🇪🇸 Barcelona, Spain