2024
BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial
Messina N, Pittet L, McDonald E, Moore C, Barry S, Bonten M, Byrne A, Campbell J, Croda J, Croda M, Dalcolmo M, de Almeida e Val F, de Oliveira R, dos Santos G, Douglas M, Gardiner K, Gwee A, Jardim B, Kollmann T, Lacerda M, Lucas M, Lynn D, Manning L, Marshall H, O’Connell A, Perrett K, Post J, Prat-Aymerich C, Rocha J, Rodriguez-Baño J, Wadia U, Warris A, Davidson A, Curtis N, Group T. BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial. Journal Of Infection 2024, 89: 106245. PMID: 39127450, PMCID: PMC11409612, DOI: 10.1016/j.jinf.2024.106245.Peer-Reviewed Original ResearchConceptsBacille Calmette-GuerinBreakthrough COVID-19Healthcare workersSevere COVID-19Risk of severe COVID-19Placebo groupSymptomatic COVID-19BCG-DenmarkRisk of symptomatic COVID-19International randomised controlled trialRandomised controlled trialsBacille Calmette-Guerin vaccineVaccination of healthcare workersHealthcare centresSARS-CoV-2 testingAsymptomatic SARS-CoV-2 infectionRandomised 1:1SARS-CoV-2 infectionCOVID-19MITT populationControlled trialsHealthcareIntradermal doseModified intentionImmunomodulatory effectsBacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial
Pittet L, Messina N, McDonald E, Orsini F, Barry S, Bonten M, Campbell J, Croda J, Croda M, Dalcolmo M, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn D, Manning L, Perrett K, Post J, Prat-Aymerich C, Richmond P, Rocha J, Rodriguez-Baño J, Warris A, Wood N, Davidson A, Curtis N, Curtis N, Davidson A, Gardiner K, Gwee A, Jamieson T, Messina N, Morawakage T, Perlen S, Perrett K, Pittet L, Sastry A, Teo J, Orsini F, Lee K, Moore C, Vidmar S, Pittet L, Ali R, Dunn R, Edler P, Gell G, Goodall C, Hall R, Krastev A, La N, McDonald E, McPhate N, Nguyen T, Ren J, Stevens L, Messina N, Alamrousi A, Bonnici R, Dang T, Germano S, Hua J, McElroy R, Razmovska M, Reddiex S, Wang X, Anderson J, Azzopardi K, Bennett-Wood V, Czajko A, Mazarakis N, McCafferty C, Oppedisano F, Ortika B, Pell C, Spry L, Toh R, Velagapudi S, Vlahos A, Wee-Hee A, Ramos P, De La Cruz K, Gamage D, Karunanayake A, Mezzetti I, Ong B, Singh R, Sooriyarachchi E, Nicholson S, Cain N, Brizuela R, Huang H, Abruzzo V, Bealing M, Bimboese P, Bowes K, Burrell E, Chan J, Cushnahan J, Elborough H, Elkington O, Fahey K, Fernandez M, Flynn C, Fowler S, Andrit M, Gladanac B, Hammond C, Ma N, Macalister S, Milojevic E, Mojeed J, Nguyen J, O'Donnell L, Olivier N, Ooi I, Reynolds S, Shen L, Sherry B, Spotswood J, Wedderburn J, Younes A, Legge D, Bell J, Cheah J, Cobbledick A, Lim K, Elia S, Addlem L, Bourke A, Brophy C, Henare N, Jenkins N, Machingaifa F, Miller S, Mitchell K, Pitkin S, Wall K, Villanueva P, Crawford N, Pittet L, Norton W, Tan N, Chengodu T, Dawson D, Gordon V, Korman T, O'Bryan J, Abruzzo V, Agius S, Bannister S, Bucholc J, Burns A, Camesella B, Carlin J, Ciaverella M, Curtis M, Firth S, Guo C, Hannan M, Hill E, Joshi S, Lieschke K, Mathers M, Odoi S, Rak A, Richards C, Steve L, Stewart C, Sudbury E, Thomson H, Watts E, Williams F, Young A, Glenn P, Kaynes A, De Floy A, Buchanan S, Sondag T, Xie I, Edmund H, Byrne B, Keeble T, Ngien B, Noonan F, Wearing-Smith M, Clarke A, Davies P, Eastwood O, Ellinghaus A, Ghieh R, Hilton Z, Jennings E, Kakkos A, Liang I, Nicol K, O'Callaghan S, Osman H, Rajaram G, Ratcliffe S, Rayner V, Salmon A, Scheppokat A, Stevens A, Street R, Toogood N, Wood N, Bahaduri T, Baulman T, Byrne J, Carter C, Corbett M, Dao A, Desylva M, Dunn A, Gardiner E, Joyce R, Kandasamy R, Munns C, Pelayo L, Sharma K, Sterling K, Uren C, Colaco C, Douglas M, Hamilton K, Bartlett A, McMullan B, Palasanthiran P, Williams P, Beardsley J, Bergant N, Lagunday R, Overton K, Post J, Al-Hindawi Y, Barney S, Byrne A, Mead L, Plit M, Lynn D, Benson S, Blake S, Botten R, Chern T, Eden G, Griffith L, James J, Lynn M, Markow A, Sacca D, Stevens N, Wesselingh S, Doran C, Barry S, Sawka A, Evans S, Goodchild L, Heath C, Krieg M, Marshall H, McMillan M, Walker M, Richmond P, Amenyogbe N, Anthony C, Arnold A, Arrowsmith B, Ben-Othman R, Clark S, Dunnill J, Eiffler N, Ewe K, Finucane C, Flynn L, Gibson C, Hartnell L, Hollams E, Hutton H, Jarvis L, Jones J, Jones J, Jones K, Kent J, Kollmann T, Lalich D, Lee W, Lim R, McAlister S, McDonald F, Meehan A, Minhaj A, Montgomery L, O'Donnell M, Ong J, Ong J, Parkin K, Perez G, Power C, Rezazadeh S, Richmond H, Rogers S, Schultz N, Shave M, Skut P, Stiglmayer L, Truelove A, Wadia U, Wallace R, Waring J, England M, Latkovic E, Manning L, Herrmann S, Lucas M, Lacerda M, Andrade P, Barbosa F, Barros D, Brasil L, Capella A, Castro R, Costa E, de Souza D, Dias M, Dias J, Ferreira K, Figueiredo P, Freitas T, Furtado A, Gama L, Godinho V, Gouy C, Hinojosa D, Jardim B, Jardim T, Junior J, Lima A, Maia B, Marins A, Mazurega K, Medeiros T, Melo R, Moraes M, Nascimento E, Neves J, Oliveira M, Oliveira T, Oliveira I, Otsuka A, Paes R, Pereira H, Pereira G, Prado C, Queiroz E, Rodrigues L, Rodrigues B, Sampaio V, Santos A, Santos D, Santos T, Santos E, Sartim A, Silva A, Silva J, Silva E, Simão M, Soares C, Sousa A, Trindade A, Val F, Vasconcelos A, Vasconcelos H, Croda J, Abreu C, Almeida K, de Andrade C, Angelo J, de Araújo Arcanjo G, Arruda B, Ayala W, Barbosa A, Batista F, de Morais Batista F, de Jesus Costa M, Croda M, da Cruz L, Diogo R, Escobar R, Fernandes I, Figueiredo L, Gonçalves L, Lahdo S, dos Santos Lencina J, de Lima G, MEIRELES B, Moreira D, Muranaka L, de Oliveira A, de Oliveira K, de Oliveira M, de Oliveira R, dos Reis Pereira A, Puga M, Ramos C, da Rosa T, dos Santos K, dos Santos C, dos Santos D, Santos K, da Silva P, da Silva P, dos Santos Silva D, da Silva P, da Rosa Soares B, Sperotto M, Tadokoro M, Tsuha D, Vieira H, Dalcolmo M, da Paixão C, Castro G, Collopy S, da Costa Silva R, da Silveira S, Da-Cruz A, de Carvalho A, de Cássia Batista R, De Freitas M, de Oliveira Ferreira A, de Souza A, Doblas P, dos Santos A, dos Santos V, dos Santos Gomes D, Fortunato A, Gomes-Silva A, Gonçalves M, Meireless P, da Costa Carvalho E, do Couto Motta F, de Mendonça L, dos Santos Pandine G, Pereira R, Maia I, da Rocha J, Romano J, dos Santos G, da Silva E, de Siqueira M, Soares Á, Bonten M, Arroyo S, Besten H, Boon A, Brakke K, Janssen A, Koopmans M, Lemmens T, Leurink T, Prat-Aymerich C, Septer-Bijleveld E, Stadhouders K, Troeman D, van der Waal M, van Opdorp M, van Sluis N, Wolters B, Kluytmans J, Romme J, van den Bijllaardt W, van Mook L, van Rijen M, Filius P, Gisolf J, Greven F, Huijbens D, Hassing R, Pon R, Preijers L, van Leusen J, Verheij H, Boersma W, Brans E, Kloeg P, Molenaar-Groot K, Nguyen N, Paternotte N, Rol A, Stooper L, Dijkstra H, Eggenhuizen E, Huijs L, Moorlag S, Netea M, Pranger E, Taks E, Oever J, Heine R, Blauwendraat K, Meek B, Erkaya I, Harbech H, Roescher N, Peeters R, Riele M, Zhou C, Calbo E, Marti C, Palomares E, Porcuna T, Barriocanal A, Barriocanal A, Casas I, Dominguez J, Esteve M, Lacoma A, Latorre I, Molina G, Molina B, Rosell A, Vidal S, Barrera L, Bustos N, Calderón I, Campos D, Carretero J, Castellano A, Compagnone R, de Arellano E, de la Serna A, del Toro Lopez M, Espindola M, Gutierrez A, Hernandez A, Jiménez V, Moreno E, Navarrete N, Paño T, Rodríguez-Baño J, Tristán E, Villegas M, Garces A, Amo E, Guerrero R, Goikoetxea J, Jorge L, Perez C, Álvarez M, Cuadra M, de las Revillas Almajano F, Garcia P, Poderos T, Rico C, Sanchez B, Valero O, Vega N, Campbell J, Barnes A, Catterick H, Cranston T, Dawe P, Fletcher E, Fouracre L, Gifford A, Gow N, Kirkwood J, Martin C, McAnew A, Mitchell M, Newman G, O'Connell A, Onysk J, Quinn L, Rhodes S, Stone S, Symons L, Tripp H, Watkins D, Whale B, Harding A, Lockhart G, Sidaway-Lee K, Campbell J, Hilton S, Manton S, Webber-Rookes D, Winder R, Moore J, Bateman F, Gibbons M, Knight B, Moss J, Statton S, Studham J, Hall L, Moyle W, Venton T. Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial. EClinicalMedicine 2024, 72: 102616. PMID: 38774675, PMCID: PMC11106519, DOI: 10.1016/j.eclinm.2024.102616.Peer-Reviewed Original ResearchBacille Calmette-Guerin vaccineBacille Calmette-GuerinRandomised controlled phase 3 trialControlled phase 3 trialPhase 3 trialIntention-to-treatRespiratory illnessBCG-DenmarkControl groupHealthcare workersDecreased all-cause mortalityRisk of severe diseasePresence of co-morbidityAssociated with protectionAll-cause mortalityEpisodes of illnessRespiratory infectionsIncreased riskHealthcare centresSecondary outcomesCo-morbiditySevere diseaseOff-target effectsSevere episodesVaccineEffect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial
dos Santos P, Messina N, de Oliveira R, da Silva P, Puga M, Dalcolmo M, dos Santos G, de Lacerda M, Jardim B, de Almeida e Val F, Curtis N, Andrews J, Croda J. Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial. The Lancet Infectious Diseases 2024, 24: 594-601. PMID: 38423021, PMCID: PMC11111441, DOI: 10.1016/s1473-3099(23)00818-6.Peer-Reviewed Original ResearchConceptsQuantiFERON-TB GoldPlacebo groupEffect of BCG vaccinationBCG vaccinationBCG groupBCG-DenmarkHealth-care workersNegative baseline resultsMonths of treatmentMycobacterium tuberculosis infectionAdult pulmonary tuberculosisQuantiFERON-TBMedian ageRandomised controlled trialsPulmonary tuberculosisNo significant differenceEfficacy outcomesTuberculosis infectionClinical trialsControlled trialsEffect of vaccinationTreatment drugsTuberculosis preventionSubstudySignificant difference
2023
Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial
Pittet L, Moore C, McDonald E, Barry S, Bonten M, Campbell J, Croda J, Dalcolmo M, Davidson A, Douglas M, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn D, Manning L, de Oliveira R, Perrett K, Prat-Aymerich C, Richmond P, Rocha J, Rodriguez-Baño J, Warris A, Wood N, Messina N, Curtis N, Curtis N, Davidson A, Gardiner K, Gwee A, Jamieson T, Messina N, Morawakage T, Perlen S, Perrett K, Pittet L, Sastry A, Teo J, Orsini F, Lee K, Moore C, Vidmar S, Pittet L, Ali R, Dunn R, Edler P, Gell G, Goodall C, Hall R, Krastev A, La N, McDonald E, McPhate N, Nguyen T, Ren J, Stevens L, Messina N, Alamrousi A, Bonnici R, Dang T, Germano S, Hua J, McElroy R, Razmovska M, Reddiex S, Wang X, Anderson J, Azzopardi K, Bennett-Wood V, Czajko A, Mazarakis N, McCafferty C, Oppedisano F, Ortika B, Pell C, Spry L, Toh R, Velagapudi S, Vlahos A, Wee-Hee A, Ramos P, De La Cruz K, Gamage D, Karunanayake A, Mezzetti I, Ong B, Singh R, Sooriyarachchi E, Nicholson S, Cain N, Brizuela R, Huang H, Abruzzo V, Bealing M, Bimboese P, Bowes K, Burrell E, Chan J, Cushnahan J, Elborough H, Elkington O, Fahey K, Fernandez M, Flynn C, Fowler S, Andrit M, Gladanac B, Hammond C, Ma N, Macalister S, Milojevic E, Mojeed J, Nguyen J, O'Donnell L, Olivier N, Ooi I, Reynolds S, Shen L, Sherry B, Spotswood J, Wedderburn J, Younes A, Legge D, Bell J, Cheah J, Cobbledick A, Lim K, Elia S, Addlem L, Bourke A, Brophy C, Henare N, Jenkins N, Machingaifa F, Miller S, Mitchell K, Pitkin S, Wall K, Villanueva P, Crawford N, Pittet L, Norton W, Tan N, Chengodu T, Dawson D, Gordon V, Korman T, O'Bryan J, Abruzzo V, Agius S, Bannister S, Bucholc J, Burns A, Camesella B, Carlin J, Ciaverella M, Curtis M, Firth S, Guo C, Hannan M, Hill E, Joshi S, Lieschke K, Mathers M, Odoi S, Rak A, Richards C, Steve L, Stewart C, Sudbury E, Thomson H, Watts E, Williams F, Young A, Glenn P, Kaynes A, De Floy A, Buchanan S, Sondag T, Xie I, Edmund H, Byrne B, Keeble T, Ngien B, Noonan F, Wearing-Smith M, Clarke A, Davies P, Eastwood O, Ellinghaus A, Ghieh R, Hilton Z, Jennings E, Kakkos A, Liang I, Nicol K, O'Callaghan S, Osman H, Rajaram G, Ratcliffe S, Rayner V, Salmon A, Scheppokat A, Stevens A, Street R, Toogood N, Wood N, Bahaduri T, Baulman T, Byrne J, Carter C, Corbett M, Dao A, Desylva M, Dunn A, Gardiner E, Joyce R, Kandasamy R, Munns C, Pelayo L, Sharma K, Sterling K, Uren C, Colaco C, Douglas M, Hamilton K, Bartlett A, McMullan B, Palasanthiran P, Williams P, Beardsley J, Bergant N, Lagunday R, Overton K, Post J, Al-Hindawi Y, Barney S, Byrne A, Mead L, Plit M, Lynn D, Benson S, Blake S, Botten R, Chern T, Eden G, Griffith L, James J, Lynn M, Markow A, Sacca D, Stevens N, Wesselingh S, Doran C, Barry S, Sawka A, Evans S, Goodchild L, Heath C, Krieg M, Marshall H, McMillan M, Walker M, Richmond P, Amenyogbe N, Anthony C, Arnold A, Arrowsmith B, Ben-Othman R, Clark S, Dunnill J, Eiffler N, Ewe K, Finucane C, Flynn L, Gibson C, Hartnell L, Hollams E, Hutton H, Jarvis L, Jones J, Jones J, Jones K, Kent J, Kollmann T, Lalich D, Lee W, Lim R, McAlister S, McDonald F, Meehan A, Minhaj A, Montgomery L, O'Donnell M, Ong J, Ong J, Parkin K, Perez G, Power C, Rezazadeh S, Richmond H, Rogers S, Schultz N, Shave M, Skut P, Stiglmayer L, Truelove A, Wadia U, Wallace R, Waring J, England M, Latkovic E, Manning L, Herrmann S, Lucas M, Lacerda M, Andrade P, Barbosa F, Barros D, Brasil L, Capella A, Castro R, Costa E, de Souza D, Dias M, Dias J, Ferreira K, Figueiredo P, Freitas T, Furtado A, Gama L, Godinho V, Gouy C, Hinojosa D, Jardim B, Jardim T, Junior J, Lima A, Maia B, Marins A, Mazurega K, Medeiros T, Melo R, Moraes M, Nascimento E, Neves J, Oliveira M, Oliveira T, Oliveira I, Otsuka A, Paes R, Pereira H, Pereira G, Prado C, Queiroz E, Rodrigues L, Rodrigues B, Sampaio V, Santos A, Santos D, Santos T, Santos E, Sartim A, Silva A, Silva J, Silva E, Simão M, Soares C, Sousa A, Trindade A, Val F, Vasconcelos A, Vasconcelos H, Croda J, Abreu C, Almeida K, de Andrade C, Angelo J, de Araújo Arcanjo G, Arruda B, Ayala W, Barbosa A, Batista F, de Morais Batista F, de Jesus Costa M, Croda M, da Cruz L, Diogo R, Escobar R, Fernandes I, Figueiredo L, Gonçalves L, Lahdo S, dos Santos Lencina J, de Lima G, Matos L, Meireles B, Moreira D, Muranaka L, de Oliveira A, de Oliveira K, de Oliveira M, de Oliveira R, dos Reis Pereira A, Puga M, Ramos C, da Rosa T, dos Santos K, dos Santos C, dos Santos D, Santos K, da Silva P, da Silva P, dos Santos Silva D, da Silva P, da Rosa Soares B, Sperotto M, Tadokoro M, Tsuha D, Vieira H, Dalcolmo M, da Paixão C, Castro G, Collopy S, da Costa Silva R, da Silveira S, Da-Cruz A, de Carvalho A, de Cássia Batista R, De Freitas M, de Oliveira Ferreira A, de Souza A, Doblas P, dos Santos A, dos Santos V, dos Santos Gomes D, Fortunato A, Gomes-Silva A, Gonçalves M, Meireless P, da Costa Carvalho E, do Couto Motta F, de Mendonça L, dos Santos Pandine G, Pereira R, Maia I, da Rocha J, Romano J, dos Santos G, da Silva E, de Siqueira M, Soares Á, Bonten M, Arroyo S, Besten H, Boon A, Brakke K, Janssen A, Koopmans M, Lemmens T, Leurink T, Prat-Aymerich C, Septer-Bijleveld E, Stadhouders K, Troeman D, van der Waal M, van Opdorp M, van Sluis N, Wolters B, Kluytmans J, Romme J, van den Bijllaardt W, van Mook L, van Rijen M, Filius P, Gisolf J, Greven F, Huijbens D, Hassing R, Pon R, Preijers L, van Leusen J, Verheij H, Boersma W, Brans E, Kloeg P, Molenaar-Groot K, Nguyen N, Paternotte N, Rol A, Stooper L, Dijkstra H, Eggenhuizen E, Huijs L, Moorlag S, Netea M, Pranger E, Taks E, Oever J, Heine R, Blauwendraat K, Meek B, Erkaya I, Harbech H, Roescher N, Peeters R, Riele M, Zhou C, Calbo E, Marti C, Palomares E, Porcuna T, Barriocanal A, Barriocanal A, Casas I, Dominguez J, Esteve M, Lacoma A, Latorre I, Molina G, Molina B, Rosell A, Vidal S, Barrera L, Bustos N, Calderón I, Campos D, Carretero J, Castellano A, Compagnone R, de Arellano E, de la Serna A, del Toro Lopez M, Espindola M, Gutierrez A, Hernandez A, Jiménez V, Moreno E, Navarrete N, Paño T, Rodríguez-Baño J, Tristán E, Villegas M, Garces A, Amo E, Guerrero R, Goikoetxea J, Jorge L, Perez C, Álvarez M, Cuadra M, de las Revillas Almajano F, Garcia P, Poderos T, Rico C, Sanchez B, Valero O, Vega N, Campbell J, Barnes A, Catterick H, Cranston T, Dawe P, Fletcher E, Fouracre L, Gifford A, Kirkwood J, Martin C, McAnew A, Mitchell M, Newman G, O'Connell A, Onysk J, Quinn L, Rhodes S, Stone S, Symons L, Tripp H, Warris A, Watkins D, Whale B, Harding A, Lockhart G, Sidaway-Lee K, Campbell J, Hilton S, Manton S, Webber-Rookes D, Winder R, Moore J, Bateman F, Gibbons M, Knight B, Moss J, Statton S, Studham J, Hall L, Moyle W, Venton T. Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial. EClinicalMedicine 2023, 64: 102203. PMID: 37719417, PMCID: PMC10500555, DOI: 10.1016/j.eclinm.2023.102203.Peer-Reviewed Original ResearchBacille Calmette-GuerinRecurrent herpes labialisHerpes simplex virusBCG-DenmarkHerpes labialisCold soresRandomised controlled trialsRecurrence of herpes simplex virusDose of study drugEffects of Bacille Calmette-GuerinControlled trialsAs-treated populationBacillus Calmette-Guerin vaccineRecurrent cold soresControl groupBurden of recurrenceMean survival timeIntention-to-treatNested randomised controlled trialImpact quality-of-lifeStudy drugLive attenuated vaccinesIntradermal doseOrofacial regionProportion of participantsRandomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers
Pittet L, Messina N, Orsini F, Moore C, Abruzzo V, Barry S, Bonnici R, Bonten M, Campbell J, Croda J, Dalcolmo M, Gardiner K, Gell G, Germano S, Gomes-Silva A, Goodall C, Gwee A, Jamieson T, Jardim B, Kollman T, Lacerda M, Lee K, Lucas M, Lynn D, Manning L, Marshall H, McDonald E, Munns C, Nicholson S, O’Connell A, de Oliveira R, Perlen S, Perrett K, Prat-Aymerich C, Richmond P, Rodriguez-Baño J, dos Santos G, da Silva P, Teo J, Villanueva P, Warris A, Wood N, Davidson A, Curtis N. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. New England Journal Of Medicine 2023, 388: 1582-1596. PMID: 37099341, PMCID: PMC10497190, DOI: 10.1056/nejmoa2212616.Peer-Reviewed Original ResearchConceptsBacille Calmette-GuerinModified intention-to-treat populationIntention-to-treat populationSevere COVID-19Placebo groupSymptomatic COVID-19Health care workersBCG-DenmarkPlacebo-controlled trialCare workersRisk of severe COVID-19Double-blindSaline placeboRisk of symptomatic COVID-19Severe acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Negative testRandomized trialsRespiratory syndrome coronavirus 2Hazard ratioPrimary outcomeBCG vaccinationTrial definitionSyndrome coronavirus 2Risk difference