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Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial.

ABSTRACT:

SUBMITTER: Tirupakuzhi Vijayaraghavan BK

PROVIDER: S-EPMC7456761 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial.

Tirupakuzhi Vijayaraghavan Bharath Kumar BK Jha Vivekanand V Rajbhandari Dorrilyn D Myatra Sheila Nainan SN John Oommen O Ghosh Arpita A Bassi Abhinav A Arfin Sumaiya S Kunigari Mallikarjuna M Joshi Rohina R Donaldson Lachlan L Hammond Naomi N Venkatesh Balasubramanian B

Trials 20200831 1

<h4>Objectives</h4>To evaluate the effect of the combination of hydroxychloroquine (HCQ) and standard personal protective equipment (PPE) compared to the use of standard personal protective equipment alone on the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers(HCWs) in India TRIAL DESIGN: HOPE is an investigator initiated multi-centre open-label parallel group randomized controlled trial.<h4>Participants</h4>All HCWs currently working in an environment w ...[more]

PMID: 32867852

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Project description:ObjectivesTo determine whether hydroxychloroquine when used with personal protective equipment reduces the proportion of laboratory-confirmed COVID-19 among healthcare workers in comparison to the use of personal protective equipment alone.DesignMulticentre, parallel-group, open-label randomised trial. Enrolment started on 29 June 2020 and stopped on 4 February 2021. Participants randomised in HydrOxychloroquine Prophylaxis Evaluation were followed for 6 months.Setting9 hospitals across India.ParticipantsHealthcare workers in an environment with exposure to COVID-19 were randomised in a 1:1 ratio to hydroxychloroquine plus use of personal protective equipment or personal protective equipment alone. 886 participants were screened and 416 randomised (213 hydroxychloroquine arm and 203 personal protective equipment).InterventionParticipants in intervention arm received 800 mg of hydroxychloroquine on day of randomisation and then 400 mg once a week for 12 weeks in addition to the use of personal protective equipment. In the control arm, participants continued to use personal protective equipment alone.Main outcomeProportion of laboratory-confirmed COVID-19 in the 6 months after randomisation.ResultsParticipants were young (mean age 32.1 years, SD 9.1 years) with low-comorbid burden. 47.4% were female. In the 6 months after randomisation (primary analysis population=413), 11 participants assigned to the hydroxychloroquine group and 12 participants assigned to the standard practice group met the primary endpoint (5.2% vs 5.9%; OR 0.85, 95% CI 0.35 to 2.07, p=0.72). There was no heterogeneity of treatment effect in any prespecified subgroup. There were no significant differences in the secondary outcomes. The adverse event rates were 9.9% and 6.9% in the hydroxychloroquine and standard practice arms, respectively. There were no serious adverse events in either group.Conclusions and relevanceHydroxychloroquine along with personal protective equipment was not superior to personal protective equipment alone on the proportion of laboratory-confirmed COVID-19. Definitive conclusions are precluded as the trial stopped early for futility, and hence was underpowered.Trial registration numberCTRI/2020/05/025067.

Project description:ObjectivesTo report frontline healthcare workers' (HCWs) experiences with personal protective equipment (PPE) during the COVID-19 pandemic in the UK. To understand HCWs' fears and concerns surrounding PPE, their experiences following its guidance and how these affected their perceived ability to deliver care during the COVID-19 pandemic.DesignA rapid qualitative appraisal study combining three sources of data: semistructured in-depth telephone interviews with frontline HCWs (n=46), media reports (n=39 newspaper articles and 145 000 social media posts) and government PPE policies (n=25).ParticipantsInterview participants were HCWs purposively sampled from critical care, emergency and respiratory departments as well as redeployed HCWs from primary, secondary and tertiary care centres across the UK.ResultsA major concern was running out of PPE, putting HCWs and patients at risk of infection. Following national level guidance was often not feasible when there were shortages, leading to reuse and improvisation of PPE. Frequently changing guidelines generated confusion and distrust. PPE was reserved for high-risk secondary care settings and this translated into HCWs outside these settings feeling inadequately protected. Participants were concerned about differential access to adequate PPE, particularly for women and Black, Asian and Minority Ethnic HCWs. Participants continued delivering care despite the physical discomfort, practical problems and communication barriers associated with PPE use.ConclusionThis study found that frontline HCWs persisted in caring for their patients despite multiple challenges including inappropriate provision of PPE, inadequate training and inconsistent guidance. In order to effectively care for patients during the COVID-19 pandemic, frontline HCWs need appropriate provision of PPE, training in its use as well as comprehensive and consistent guidance. These needs must be addressed in order to protect the health and well-being of the most valuable healthcare resource in the COVID-19 pandemic: our HCWs.

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