The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
275
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
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
ISGlobal
Barcelona, Spain
Confirmed cases of a COVID-19
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.
Time frame: Up to 6 months after start of treatment
SARS-CoV-2 seroconversion
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.
Time frame: Up to 6 months after start of treatment
Occurrence of any adverse event related with hydroxychloroquine treatment
Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.
Time frame: Up to 6 months after start of treatment
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers
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.
Time frame: Up to 6 months after start of treatment
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
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 6 months after start of treatment