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 : Suspended (The study has been suspended until a new epidemic curve occurs.)
First Posted : April 2, 2020
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Drug: Placebos||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Primary Completion Date :||October 3, 2020|
|Estimated Study Completion Date :||October 30, 2020|
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
Hydroxychloroquine with the following dosage:
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
Placebo with the following dosage:
- 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.
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
|Barcelona, Spain, 08036|
|Principal Investigator:||Jose Muñoz Gutiérrez, MD, PhD||Barcelona Institute for Global Health|