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
Objectives 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.Design Multicentre, parallel-group, open-label randomised t...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e059540.full |
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| author | Rohina Joshi Sudha Vidyasagar Niveditha Devasenapathy Rinaldo Bellomo Vivekanand Jha Chirag Patel Vijay Kumar Lachlan Donaldson Oommen John Balasubramanian Venkatesh Michael John Naomi Hammond Jeyaraj Pandian Ashwani Kumar Arpita Ghosh S Radhakrishnan Rajib Paul Bharath Kumar Tirupakuzhi Vijayaraghavan Dorrilyn Rajbhandari Sheila Nainan Myatra Amritendu Bhattacharya Sumaiya Arfin Abhinav Bassi Lachlan Hugh Donaldson Naomi E Hammond Mallikarjuna Kunigari Cynthia Amrutha Syed Haider Mehdi Husaini Subir Ghosh Santosh Kumar Nag Hari Krishnan Selvaraj Viny Kantroo Kamal D Shah Sheila Myatra Amritendu Battacharya Pavan Kumar Vecham Evangeline Elvira Gomathi Parthasarathy Archana Ragunathan Gnanavel Rajendra Kunjurao Pavithra Sampath Kumar Hilda Nirmala Kumari Jayanthi Swaminathan Murshid Cheriyeri Peediyekkal Arun Chander Yadav Aarthi Venkatramanan Cynthia Amrutha Sukumar Dharini Prasad Krishnanda Nayak Ravindra Prabhu Rohini Bilagi Akash Bhange Bhumika Patel Ekta Ramchandani Jinesh Patel Krupa Gandhi N Prathyusha Rayshma Rao Bonshlay Lakshmanan S Hari Krishnan Abhishek George Mehta Mousumi Pradhan Syed Haider Mehdi Husaini Shahid Ali Siddique Naved-ur Rahman Mohammad Jamalludeen Mounika Amarneni Suresh Sankar Vidya Rajesh Joshi Alka Yadav Nikhil Modi Rinku Dahiya Serena Knowles Nikita Bathla Fatima Butt |
| author_facet | Rohina Joshi Sudha Vidyasagar Niveditha Devasenapathy Rinaldo Bellomo Vivekanand Jha Chirag Patel Vijay Kumar Lachlan Donaldson Oommen John Balasubramanian Venkatesh Michael John Naomi Hammond Jeyaraj Pandian Ashwani Kumar Arpita Ghosh S Radhakrishnan Rajib Paul Bharath Kumar Tirupakuzhi Vijayaraghavan Dorrilyn Rajbhandari Sheila Nainan Myatra Amritendu Bhattacharya Sumaiya Arfin Abhinav Bassi Lachlan Hugh Donaldson Naomi E Hammond Mallikarjuna Kunigari Cynthia Amrutha Syed Haider Mehdi Husaini Subir Ghosh Santosh Kumar Nag Hari Krishnan Selvaraj Viny Kantroo Kamal D Shah Sheila Myatra Amritendu Battacharya Pavan Kumar Vecham Evangeline Elvira Gomathi Parthasarathy Archana Ragunathan Gnanavel Rajendra Kunjurao Pavithra Sampath Kumar Hilda Nirmala Kumari Jayanthi Swaminathan Murshid Cheriyeri Peediyekkal Arun Chander Yadav Aarthi Venkatramanan Cynthia Amrutha Sukumar Dharini Prasad Krishnanda Nayak Ravindra Prabhu Rohini Bilagi Akash Bhange Bhumika Patel Ekta Ramchandani Jinesh Patel Krupa Gandhi N Prathyusha Rayshma Rao Bonshlay Lakshmanan S Hari Krishnan Abhishek George Mehta Mousumi Pradhan Syed Haider Mehdi Husaini Shahid Ali Siddique Naved-ur Rahman Mohammad Jamalludeen Mounika Amarneni Suresh Sankar Vidya Rajesh Joshi Alka Yadav Nikhil Modi Rinku Dahiya Serena Knowles Nikita Bathla Fatima Butt |
| collection | DOAJ |
| description | Objectives 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.Design 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.Setting 9 hospitals across India.Participants 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).Intervention 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.Main outcome Proportion of laboratory-confirmed COVID-19 in the 6 months after randomisation.Results 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.Conclusions and relevance 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.Trial registration number CTRI/2020/05/025067. |
| format | Article |
| id | doaj-art-ae3415ae970048db8f849ec9a7de9ad3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ae3415ae970048db8f849ec9a7de9ad32025-01-28T01:30:08ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-059540Hydroxychloroquine 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 Rohina Joshi0Sudha Vidyasagar1Niveditha Devasenapathy2Rinaldo Bellomo3Vivekanand Jha4Chirag Patel5Vijay Kumar6Lachlan Donaldson7Oommen John8Balasubramanian Venkatesh9Michael JohnNaomi Hammond10Jeyaraj PandianAshwani KumarArpita Ghosh11S RadhakrishnanRajib PaulBharath Kumar Tirupakuzhi Vijayaraghavan12Dorrilyn Rajbhandari13Sheila Nainan Myatra14Amritendu Bhattacharya15Sumaiya Arfin16Abhinav Bassi17Lachlan Hugh Donaldson18Naomi E Hammond19Mallikarjuna Kunigari20Cynthia Amrutha21Syed Haider Mehdi Husaini22Subir Ghosh23Santosh Kumar Nag24Hari Krishnan Selvaraj25Viny Kantroo26Kamal D Shah27Sheila MyatraAmritendu BattacharyaPavan Kumar VechamEvangeline ElviraGomathi ParthasarathyArchana RagunathanGnanavel Rajendra KunjuraoPavithra Sampath KumarHilda Nirmala KumariJayanthi SwaminathanMurshid Cheriyeri PeediyekkalArun Chander YadavAarthi VenkatramananCynthia Amrutha SukumarDharini PrasadKrishnanda NayakRavindra PrabhuRohini BilagiAkash BhangeBhumika PatelEkta RamchandaniJinesh PatelKrupa GandhiN PrathyushaRayshma Rao Bonshlay LakshmananS Hari KrishnanAbhishek George MehtaMousumi PradhanSyed Haider Mehdi HusainiShahid Ali SiddiqueNaved-ur RahmanMohammad JamalludeenMounika AmarneniSuresh SankarVidya Rajesh JoshiAlka YadavNikhil ModiRinku DahiyaSerena Knowles28Nikita BathlaFatima Butt7 School of Population Health, University of New South Wales (UNSW), Sydney, New South Wales, AustraliaDepartment of Medicine, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, IndiaThe George Institute for Global Health India, Delhi, IndiaAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, AustralianephrologistDepartment of Biomedical Informatics, Harvard Medical School, Boston, Massachusetts, USADepartment of General Medicine, All India Institute of Medical Sciences, Patna, IndiaDepartment of Intensive Care Medicine, Royal North Shore Hospital, St Leonards, New South Wales, Australia6 George Institute for Global Health, UNSW, New Delhi, IndiaRoyal Brisbane and Women’s Hospital, Herston, Queensland, AustraliaGeorge Institute for Global Health, Camperdown, New South Wales, AustraliaThe George Institute for Global Health India, Delhi, IndiaCritical Care, Apollo Hospitals, Chennai, Tamil Nadu, India18 Critical Care Medicine, The George Institute for Global Health, Newtown, New South Wales, AustraliaHomi Bhabha National Institute, Mumbai, Maharashtra, IndiaThe George Institute for Global Health, New Delhi, Delhi, IndiaThe George Institute for Global Health, New Delhi, Delhi, IndiaThe George Institute for Global Health India, New Delhi, Delhi, IndiaThe George Institute for Global Health, Newtown, New South Wales, Australia18 Critical Care Medicine, The George Institute for Global Health, Newtown, New South Wales, AustraliaThe George Institute for Global Health, New Delhi, Delhi, IndiaKasturba Medical College, Manipal, Karnataka, IndiaAligarh Muslim University, Aligarh, Uttar Pradesh, IndiaApollo Hospitals Ahmedabad, Ahmedabad, Gujarat, IndiaChristian Hospital, Nabarangpur, Odisha, IndiaApollo Hospitals, Madurai, Tamil Nadu, IndiaIndraprastha Apollo Hospital, New Delhi, Delhi, IndiaNephroPlus Health Services, Hyderabad, Telangana, India4 Critical Care Program, The George Institute for Global Health, Sydney, New South Wales, AustraliaObjectives 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.Design 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.Setting 9 hospitals across India.Participants 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).Intervention 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.Main outcome Proportion of laboratory-confirmed COVID-19 in the 6 months after randomisation.Results 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.Conclusions and relevance 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.Trial registration number CTRI/2020/05/025067.https://bmjopen.bmj.com/content/12/6/e059540.full |
| spellingShingle | Rohina Joshi Sudha Vidyasagar Niveditha Devasenapathy Rinaldo Bellomo Vivekanand Jha Chirag Patel Vijay Kumar Lachlan Donaldson Oommen John Balasubramanian Venkatesh Michael John Naomi Hammond Jeyaraj Pandian Ashwani Kumar Arpita Ghosh S Radhakrishnan Rajib Paul Bharath Kumar Tirupakuzhi Vijayaraghavan Dorrilyn Rajbhandari Sheila Nainan Myatra Amritendu Bhattacharya Sumaiya Arfin Abhinav Bassi Lachlan Hugh Donaldson Naomi E Hammond Mallikarjuna Kunigari Cynthia Amrutha Syed Haider Mehdi Husaini Subir Ghosh Santosh Kumar Nag Hari Krishnan Selvaraj Viny Kantroo Kamal D Shah Sheila Myatra Amritendu Battacharya Pavan Kumar Vecham Evangeline Elvira Gomathi Parthasarathy Archana Ragunathan Gnanavel Rajendra Kunjurao Pavithra Sampath Kumar Hilda Nirmala Kumari Jayanthi Swaminathan Murshid Cheriyeri Peediyekkal Arun Chander Yadav Aarthi Venkatramanan Cynthia Amrutha Sukumar Dharini Prasad Krishnanda Nayak Ravindra Prabhu Rohini Bilagi Akash Bhange Bhumika Patel Ekta Ramchandani Jinesh Patel Krupa Gandhi N Prathyusha Rayshma Rao Bonshlay Lakshmanan S Hari Krishnan Abhishek George Mehta Mousumi Pradhan Syed Haider Mehdi Husaini Shahid Ali Siddique Naved-ur Rahman Mohammad Jamalludeen Mounika Amarneni Suresh Sankar Vidya Rajesh Joshi Alka Yadav Nikhil Modi Rinku Dahiya Serena Knowles Nikita Bathla Fatima Butt 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/6/e059540.full |
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hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia AT alkayadav hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia AT nikhilmodi hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia AT rinkudahiya hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia AT serenaknowles hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia AT nikitabathla hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia AT fatimabutt hydroxychloroquinepluspersonalprotectiveequipmentversuspersonalprotectiveequipmentaloneforthepreventionoflaboratoryconfirmedcovid19infectionsamonghealthcareworkersamulticentreparallelgrouprandomisedcontrolledtrialfromindia |