{"doi":"10.2139/ssrn.3927782","title":"Hydroxychloroquine Plus Standard Personal Protective Equipment Versus Standard Personal Protective Equipment Alone for the Prevention of Laboratory Confirmed Covid-19 Infections Among Healthcare Workers: A Multi-Centre Parallel Group Randomized Controlled Trial from India","abstract":null,"journal":"SSRN Electronic Journal","year":null,"id":683169,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":22569,"name":"Vivekanand Jha","orcid":"0000-0002-8015-9470","position":1,"is_corresponding":false},{"id":1574929,"name":"Dorrilyn Rajbhandari","orcid":null,"position":2,"is_corresponding":false},{"id":366381,"name":"Sheila Nainan Myatra","orcid":"0000-0001-6761-163X","position":3,"is_corresponding":false},{"id":535368,"name":"Arpita Ghosh","orcid":"0009-0000-0812-7477","position":4,"is_corresponding":false},{"id":683905,"name":"Amritendu Bhattacharya","orcid":"0000-0001-6237-7290","position":5,"is_corresponding":false},{"id":1574933,"name":"Sumaiya Arfin","orcid":null,"position":6,"is_corresponding":false},{"id":1574934,"name":"Abhinav Bassi","orcid":null,"position":7,"is_corresponding":false},{"id":1784679,"name":"Lachlan Donaldson","orcid":null,"position":8,"is_corresponding":false},{"id":95011,"name":"Naomi Hammond","orcid":"0000-0002-6559-7747","position":9,"is_corresponding":false},{"id":48470,"name":"Oommen John","orcid":"0000-0002-9008-1726","position":10,"is_corresponding":false},{"id":942,"name":"Rohina Joshi","orcid":"0000-0002-3374-401X","position":11,"is_corresponding":false},{"id":1574937,"name":"Mallikarjuna Kunigari","orcid":null,"position":12,"is_corresponding":false},{"id":1574938,"name":"Cynthia Amrutha","orcid":null,"position":13,"is_corresponding":false},{"id":1784680,"name":"Syed Haider Mehdi Hussaini","orcid":null,"position":14,"is_corresponding":false},{"id":1574940,"name":"Subir Ghosh","orcid":null,"position":15,"is_corresponding":false},{"id":1574941,"name":"Santosh Kumar Nag","orcid":null,"position":16,"is_corresponding":false},{"id":1784681,"name":"Harikrishnan S","orcid":null,"position":17,"is_corresponding":false},{"id":1574943,"name":"Viny Kantroo","orcid":null,"position":18,"is_corresponding":false},{"id":1784682,"name":"Kamal D. Shah","orcid":null,"position":19,"is_corresponding":false},{"id":642624,"name":"Balasubramanian Venkatesh","orcid":"0000-0002-3234-5244","position":20,"is_corresponding":false},{"id":1784683,"name":"HOPE Investigators","orcid":null,"position":21,"is_corresponding":false},{"id":1784678,"name":"Bharath Kumar Tirupakuzhi Vijavaraghavan","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Hydroxychloroquine Plus Standard Personal Protective Equipment Versus Standard Personal Protective Equipment Alone for the Prevention of Laboratory Confirmed Covid-19 Infections Among Healthcare Workers: A Multi-Centre Parallel Group Randomized Controlled Trial from India","abstract":"Background: Healthcare workers (HCWs),particularly from lower-middle income countries (LMIC), are at high risk of acquiring COVID-19.  Limited data exist on the effectiveness of hydroxychloroquine as prophylaxis. Our trial evaluated the effectiveness of a 12-week regimen of hydroxychloroquine among HCWs on the risk of laboratory-confirmed COVID-19 in the 6 months after randomization <br><br>Methods: We conducted a multicentre parallel-group open-label randomized controlled trial in 9 centres across India. HCWs serving in an environment with exposure to COVID-19 were eligible and randomized in a 1:1 ratio to hydroxychloroquine plus standard practice or to standard practice alone (role-appropriate personal protective equipment). In the intervention arm, participants received 2 doses of 400mg hydroxychloroquine at randomization followed by a weekly  dose for 12 weeks. The primary outcome was the proportion of laboratory-confirmed COVID-19 in the 6 months after randomization using an intention-to-treat analysis. The trial was registered on Clinical Trials Registry of India(CTRI/2020/05/025067). <br><br>Findings: From 29<sup>th</sup> June 2020 to 4<sup>th</sup> February 2021, 886 participants were screened and 416 were randomized (203-standard practice and 213- hydroxychloroquine plus standard practice). In the 6 months after randomization (primary analysis population=413), 11 participants assigned to the hydroxychloroquine group and 12 participants assigned to the standard practice group met the primary end point[ 5.1% vs 5.9%; OR 0.85, [95% CI 0.35-2.06] p=0.71]. There was no heterogeneity of treatment effect on the primary outcome in any  of the pre-specified subgroups. There were no significant differences in any of 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. <br><br>Interpretation: Hydroxychloroquine along with standard practice was not superior to standard practice alone on the proportion of lab-confirmed COVID-19. However, conclusions are limited by the premature trial cessation.<br><br>Trial Registration: Clinical Trials Registry of India (CTRI/2020/05/025067).<br><br>Funding:  Wesley Medical Research, Australia<br><br>Declaration of Interest: OJ reports being a member of the WHO R&D Blueprint Safety Monitoring Team, ACT Acclerator-R&D Digital Health working group and COVID-19 Clinical Research Coalition data sharing working group. Remaining authors have nothing to declare. <br><br>Ethical Approval: Written informed consent was obtained from all participants. The<br>trial was approved by the Ethics Committee at all participating sites (coordinating centre EC approval number: The George Institute Ethics Committee:08-2020)","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"26207759","pmcid":null,"openalex_id":"https://openalex.org/W3204679695","authors":[],"funders":[],"total_grants":0,"fwci":null,"citation_percentile":null,"influential_citations":0,"citation_trend":[],"oa_status":"green","license":null,"oa_locations":[{"url":"https://doi.org/10.2139/ssrn.3927782","host_type":"repository"},{"url":"https://doi.org/10.2139/ssrn.3927782","host_type":"repository"}],"fields_of_study":["COVID-19 Clinical Research Studies","SARS-CoV-2 and COVID-19 Research","COVID-19 and healthcare impacts"],"mesh_terms":[],"keywords":["Personal protective equipment","Randomized controlled trial","Hydroxychloroquine","Medicine","Healthcare worker","Coronavirus disease 2019 (COVID-19)","Health care","Standard of care","Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)","Medical emergency","Surgery","Internal medicine"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-17T22:58:26.670665Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}