COVID-19
Conditions
Keywords
PrEP, hydroxychloroquine, prophylaxis, pre-exposure, healthcare workers
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.
Interventions
DRUGHydroxychloroquine
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
DRUGPlacebos
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
Sponsors
Hospital Clinic of Barcelona
Laboratorios Rubió
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Plató
Hospital de Granollers
Barcelona Institute for Global Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19 | Up to 6 months after start of treatment | — |
| 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. |
Countries
Spain
Outcome results
None listed