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Completed

NCT Number: NCT04331834

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ISGlobal

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine with the following dosage:

  • day 0: 400 mg (2 tablets)
  • day 1: 400 mg (2 tablets)
  • day 2: 400 mg (2 tablets)
  • day 3: 400 mg (2 tablets)
  • weekly: 400 mg (2 tablets) for a period of six months

Placebos

Drug

Placebo with the following dosage:

  • day 0: 400 mg (2 tablets)
  • day 1: 400 mg (2 tablets)
  • day 2: 400 mg (2 tablets)
  • day 3: 400 mg (2 tablets)
  • weekly: 400 mg (2 tablets) for a period of six months

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19

    Time frame: Up to 6 months after start of treatment

  5. 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.

Sponsors and collaborators

Lead sponsor

Barcelona Institute for Global Health

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Hospital Clinic of Barcelona
  • Hospital Plató
  • Hospital de Granollers
  • Laboratorios Rubió

Registry information

Official study title

Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial

Acronym: PrEP_COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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