Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratory-confirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India
Bharath Kumar Tirupakuzhi Vijayaraghavan, Vivekanand Jha, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Arpita Ghosh, Amritendu Bhattacharya, Sumaiya Arfin, Abhinav Bassi, Lachlan Hugh Donaldson, Naomi E Hammond, Oommen John, Rohina Joshi, Mallikarjuna Kunigari, Cynthia Amrutha, Syed Haider Mehdi Husaini, Subir Ghosh, Santosh Kumar Nag, Hari Krishnan Selvaraj, Viny Kantroo, Kamal D Shah, Balasubramanian Venkatesh
BMJ Open, doi:10.1136/bmjopen-2021-059540
Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratoryconfirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India. BMJ Open 2022;12:e059540.
Ethics approval This study involves human participants and was approved by The George Institute Ethics Committee (reference number: 08-2020). Participants gave informed consent to participate in the study before taking part. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request. Deidentified patient data will be made available beginning 6 months after publication of the study and ending at 2 years. All requests for data sharing must be accompanied by a formal request, a study proposal with clear statement of aims and hypotheses and a statistical analysis plan. All applications will be assessed by the HOPE Management Committee. Applications from investigators with suitable academic capability to conduct the proposed work will be given consideration. Any proposal will require approval from the ethics committee which approved the conduct of this trial prior to sharing of any patient data. If a proposal is approved, a signed data transfer agreement will be required before data sharing. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated..
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doi:10.1002/cpt.1955{ 'indexed': {'date-parts': [[2022, 7, 1]], 'date-time': '2022-07-01T03:11:52Z', 'timestamp': 1656645112558},
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'abstract': '<jats:sec><jats:title>Objectives</jats:title><jats:p>To 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.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Multicentre, '
'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.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>9 '
'hospitals across '
'India.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>Healthcare '
'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).</jats:p></jats:sec><jats:sec><jats:title>Intervention</jats:title><jats:p>Participants '
'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.</jats:p></jats:sec><jats:sec><jats:title>Main outcome</jats:title><jats:p>Proportion '
'of laboratory-confirmed COVID-19 in the 6 months after '
'randomisation.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Participants '
'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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and '
'relevance</jats:title><jats:p>Hydroxychloroquine 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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration '
'number</jats:title><jats:p>CTRI/2020/05/025067.</jats:p></jats:sec>',
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