Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic (PrEP_COVID)
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ClinicalTrials.gov Identifier: NCT04331834 |
Recruitment Status :
Completed
First Posted : April 2, 2020
Last Update Posted : February 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Hydroxychloroquine Drug: Placebos | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 275 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial |
Actual Study Start Date : | April 3, 2020 |
Actual Primary Completion Date : | June 25, 2020 |
Actual Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Pre-exposure prophylaxis of SARS-CoV-2
Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
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Drug: Hydroxychloroquine
Hydroxychloroquine with the following dosage:
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Placebo Comparator: Control group with placebo
Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
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Drug: Placebos
Placebo with the following dosage:
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- Confirmed cases of a COVID-19 [ Time Frame: 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.
- SARS-CoV-2 seroconversion [ Time Frame: 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.
- Occurrence of any adverse event related with hydroxychloroquine treatment [ Time Frame: 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.
- Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers [ Time Frame: 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.
- Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19 [ Time Frame: Up to 6 months after start of treatment ]
- COVID-19 Biobank [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331834
Spain | |
ISGlobal | |
Barcelona, Spain, 08036 |
Principal Investigator: | Jose Muñoz Gutiérrez, MD, PhD | Barcelona Institute for Global Health |
Responsible Party: | Barcelona Institute for Global Health |
ClinicalTrials.gov Identifier: | NCT04331834 |
Other Study ID Numbers: |
PrEP_COVID |
First Posted: | April 2, 2020 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
PrEP hydroxychloroquine prophylaxis pre-exposure healthcare workers |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Hydroxychloroquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |