{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:38:09Z","timestamp":1760834289342,"version":"build-2065373602"},"reference-count":6,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2020,11,12]],"date-time":"2020-11-12T00:00:00Z","timestamp":1605139200000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Swiss National Fund","award":["33IC30_166819"],"award-info":[{"award-number":["33IC30_166819"]}]},{"DOI":"10.13039\/100030888","name":"Fondation priv\u00e9e des HUG","doi-asserted-by":"crossref","award":["no grant number"],"award-info":[{"award-number":["no grant number"]}],"id":[{"id":"10.13039\/100030888","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,10,16]]},"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Lopinavir\/ritonavir (LPV\/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>COPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (\u226516 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV\/r (400\u2009mg\/100\u2009mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with \u22651 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and\/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV\/r arm and 100 to the standard of care arm, 300 participants in total.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Ethics approval has been granted by the Commission Cantonale d\u2019Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>Clinicaltrials.gov Registry (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04364022\">NCT04364022<\/jats:ext-link>); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Registered report identifier<\/jats:title>\n                  <jats:p>CCER 2020-0864.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-040110","type":"journal-article","created":{"date-parts":[[2020,11,12]],"date-time":"2020-11-12T16:12:50Z","timestamp":1605197570000},"page":"e040110","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct04364022","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8530-748X","authenticated-orcid":false,"given":"Mikaela","family":"Smit","sequence":"first","affiliation":[{"name":"HIV Unit, Geneva University Hospitals, Geneva, Switzerland"},{"name":"Faculty of Medicine, University of Geneva, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annalisa","family":"Marinosci","sequence":"additional","affiliation":[{"name":"HIV Unit, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanni Jacopo","family":"Nicoletti","sequence":"additional","affiliation":[{"name":"Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5667-0968","authenticated-orcid":false,"given":"Thomas","family":"Perneger","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Geneva, Geneva, Switzerland"},{"name":"Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvio","family":"Ragozzino","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Hospital Epidemiology, University of Basel, Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diego O","family":"Andrey","sequence":"additional","affiliation":[{"name":"HIV Unit, Geneva University Hospitals, Geneva, Switzerland"},{"name":"Faculty of Medicine, University of Geneva, Geneva, Switzerland"},{"name":"Division of Laboratory Medicine, Diagnostic Department, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcel","family":"Stoeckle","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Hospital Epidemiology, University of Basel, Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6957-0920","authenticated-orcid":false,"given":"Frederique","family":"Jacquerioz","sequence":"additional","affiliation":[{"name":"Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Lebowitz","sequence":"additional","affiliation":[{"name":"Infection Control Programme, Geneva University Hospitals, Geneva, Switzerland"},{"name":"Direction Generale de la Sante, Republique et Canton de Geneve, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Agoritsas","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Geneva, Geneva, Switzerland"},{"name":"Department of Medicine, Geneva University Hospitals, Geneva, Switzerland"},{"name":"Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Meyer","sequence":"additional","affiliation":[{"name":"Centre for Vaccinology, Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Herve","family":"Spechbach","sequence":"additional","affiliation":[{"name":"Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julien","family":"Salamun","sequence":"additional","affiliation":[{"name":"Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moritz","family":"Back","sequence":"additional","affiliation":[{"name":"Gesundheitsdepartement, Canton of Basel City, Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carla","family":"Schaubhut","sequence":"additional","affiliation":[{"name":"Gesundheitsdepartement, Canton of Basel City, Basel, 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