COVID-19
Conditions
Sponsors
ISGlobal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Negative PCR and negative serology at day 0 - Healthcare worker at Hospital Clinic of Barcelona - Female participants: negative for pregnancy test - Willing to participate in the study - Able to sign the informed consent form 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 435 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Age 5 upper normal limit, as determined on day 0 blood test o Previous myocardial infarction o Myasthenia gravis o Psoriasis or porphyria o Glomerular clearance < 10ml/min o Previous history of severe hypoglycaemia o Ongoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of COVID-19 disease during an epidemic period.;Secondary Objective: 1) To assess the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of exposure to SARS-CoV-2 (defined by seroconversion) during an epidemic period. 2) To evaluate the safety of PrEP with hydroxychloroquine in adults. 3) To describe the incidence of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 infection. 4) To identify clinical, analytical and microbiological predictors of COVID-19 among healthcare workers at high risk of SARS-CoV-2 infection. 5) To set up a repository (biobank) of serum samples obtained from healthcare workers at high risk of SARS-CoV-2 infection for future research on blood markers to predict SARS-CoV-2 infection.;Primary end point(s): Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) 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 at day 0.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) 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) The occurrence of any adverse event related with hydroxychloroquine treatment. We will compare the incidence of clinical and/or laboratory adverse events in the hydroxychloroquine PrEP group and the non-PrEP group. 3) 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 non-PrEP 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. 5) 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.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Spain
Contacts
Public ContactJose Muñoz Gutiérrez
ISGlobal
Outcome results
None listed