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Berta Grau-Pujol
Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - Universitat de Bareclona, Barcelona, Spain
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7320-0965
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Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period.
Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400mg of hydroxychloroquine daily the first four consecutive days and subsequently, 400mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets.
Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Both groups showed similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041). Given the national epidemic incidence decay, only one participant in each group was COVID-19 diagnosed. Consequently, our study design deemed underpowered to evaluate any benefit regarding PrEP efficacy.
Conclusions: First month follow-up analysis displayed that PrEP with hydroxychloroquine at low doses is safe.
Trial registration: This trial was registered at clinicaltrials.gov (NCT04331834) on April 2nd 2020. https://clinicaltrials.gov/ct2/show/NCT04331834?term=NCT04331834&draw=2&rank=1
Keywords
hydroxychloroquine, COVID-19, pre-exposure prophylaxis, prevention, health-care workers, control, SARS-CoV-2
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CURRENT STATUS: Under Review
Version 1
Posted 13 Apr, 2021
No community comments so far
Editorial decision: Minor revision
On 02 Aug, 2021
Review #3 received
Received 01 Aug, 2021
Reviewer #3 agreed
On 21 Jun, 2021
Review #2 received
Received 20 Jun, 2021
Reviewer #2 agreed
On 28 May, 2021
Review #1 received
Received 07 May, 2021
Reviews received
Received 07 May, 2021
Reviewer #1 agreed
On 06 May, 2021
Reviewers invited
Invitations sent on 03 May, 2021
Editor assigned
On 26 Apr, 2021
Submission checks complete
On 12 Apr, 2021
First submitted
On 26 Jan, 2021
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Subject Areas
Clinical Pharmacology
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A new preprint design is coming!
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Berta Grau-Pujol
Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - Universitat de Bareclona, Barcelona, Spain
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7320-0965
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 13 Apr, 2021
No community comments so far
Editorial decision: Minor revision
On 02 Aug, 2021
Review #3 received
Received 01 Aug, 2021
Reviewer #3 agreed
On 21 Jun, 2021
Review #2 received
Received 20 Jun, 2021
Reviewer #2 agreed
On 28 May, 2021
Review #1 received
Received 07 May, 2021
Reviews received
Received 07 May, 2021
Reviewer #1 agreed
On 06 May, 2021
Reviewers invited
Invitations sent on 03 May, 2021
Editor assigned
On 26 Apr, 2021
Submission checks complete
On 12 Apr, 2021
First submitted
On 26 Jan, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Clinical Pharmacology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period.
Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400mg of hydroxychloroquine daily the first four consecutive days and subsequently, 400mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets.
Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Both groups showed similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041). Given the national epidemic incidence decay, only one participant in each group was COVID-19 diagnosed. Consequently, our study design deemed underpowered to evaluate any benefit regarding PrEP efficacy.
Conclusions: First month follow-up analysis displayed that PrEP with hydroxychloroquine at low doses is safe.
Trial registration: This trial was registered at clinicaltrials.gov (NCT04331834) on April 2nd 2020. https://clinicaltrials.gov/ct2/show/NCT04331834?term=NCT04331834&draw=2&rank=1
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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