Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers: early termination of a phase 3, randomised, open-label, controlled clinical trial.
COVID-19
Global health
Prophylaxis
Journal
BMC research notes
ISSN: 1756-0500
Titre abrégé: BMC Res Notes
Pays: England
ID NLM: 101462768
Informations de publication
Date de publication:
28 Feb 2023
28 Feb 2023
Historique:
received:
01
07
2022
accepted:
30
01
2023
entrez:
28
2
2023
pubmed:
1
3
2023
medline:
3
3
2023
Statut:
epublish
Résumé
To assess the effectiveness and safety of hydroxychloroquine (HCQ) prophylaxis for the prevention of SARS-CoV-2 infection in healthcare workers (HCW) on duty during the COVID-19 pandemic. A total of 68 HCWs met the eligibility criteria were randomly allocated to receive HCQ (n = 36) or not (n = 32). There were no significant differences between groups in respects to age, gender, or medical history. Eight participants met the primary efficacy endpoint of SAR-CoV-2 infection during the study period; there was no difference in incidence of SARS-CoV-2 infections between both study arms (HCQ: 5 vs Control: 3, p = 0.538). The relative risk of SARS-CoV-2 infection in the HCQ arm was 1.69 compared to the control group (95%CI 0.41-7.11, p = 0.463); due to poor participant accrual, the resulting statistical power of the primary efficacy outcome was 11.54%. No serious adverse events occurred; however, two (2/36, 5.6%) participants no longer wished to participate in the study and withdrew consent due to recurring grade 1 and 2 adverse events. ClinicalTrials.gov ID: NCT04414241. (Registered on June 4, 2020).
Identifiants
pubmed: 36849996
doi: 10.1186/s13104-023-06281-7
pii: 10.1186/s13104-023-06281-7
pmc: PMC9970848
doi:
Substances chimiques
Hydroxychloroquine
4QWG6N8QKH
Banques de données
ClinicalTrials.gov
['NCT04414241']
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
22Informations de copyright
© 2023. The Author(s).
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