Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial
•A randomised control trial of the efficacy of a nasal spray against SARS-CoV-2.•The spray combines natural viricidal agents with mechanisms to prevent viral entry.•The test agent significantly reduced the infection rate from 34.5% to 13.1%.•Fewer patients were symptomatic in the test group [17.6% v...
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| Veröffentlicht in: | Journal of clinical virology 2022-10, Vol.155, p.105248-105248, Article 105248 |
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| container_title | Journal of clinical virology |
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| creator | Balmforth, Damian Swales, James A Silpa, Laurence Dunton, Alan Davies, Kay E. Davies, Stephen G. Kamath, Archana Gupta, Jayanti Gupta, Sandeep Masood, M.Abid McKnight, Áine Rees, Doug Russell, Angela J. Jaggi, Manu Uppal, Rakesh |
| description | •A randomised control trial of the efficacy of a nasal spray against SARS-CoV-2.•The spray combines natural viricidal agents with mechanisms to prevent viral entry.•The test agent significantly reduced the infection rate from 34.5% to 13.1%.•Fewer patients were symptomatic in the test group [17.6% vs 34.6%; p |
| doi_str_mv | 10.1016/j.jcv.2022.105248 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9313533</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1386653222001809</els_id><sourcerecordid>2702186849</sourcerecordid><originalsourceid>FETCH-LOGICAL-c451t-6cca0d695199c1d09fa303b0cd7b1bb03801a6ed4a64054eb06d4067584105713</originalsourceid><addsrcrecordid>eNp9UU1v1DAQjRCIlsIP4IJ85NAsdhw7CUhIq1X5kCohUeBqTexJ1yuvHewk0v4vfiDebqngwsn2zHtvnucVxUtGV4wy-Wa32ullVdGqym9R1e2j4py1DS9FJ5vH-c5bWUrBq7PiWUo7SpngdfO0OOOiy_BKnhe_rhZwM0zW35JpiwSHwWrQBwLekAQDTgcSBgLEhwUdGWMYtwcHerKaeEjgSBojHIj1d_Qx4oJ-ssEfWTfrrzflJvwoq9wfUB_rb8ma7Gc32VJnYMRLYsLcOyS9s95ckjGLYx9KHXI3OIe5FrOZsLcJDZmiBfe8eDKAS_ji_rwovn-4-rb5VF5_-fh5s74udS3YVEqtgRrZCdZ1mhnaDcAp76k2Tc_6nvKWMpBoapA1FTX2VJqayka0dV5nw_hF8f6kO879Hs2dYXBqjHYP8aACWPVvx9utug2L6jjjgvMs8PpeIIafM6ZJ5V9odA48hjmpqqEVa2VbdxnKTlAdQ0oRh4cxjKpj2mqnctrqmLY6pZ05r_7298D4E28GvDsBMG9psRhV0ha9RmNjjkOZYP8j_xtViL23</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2702186849</pqid></control><display><type>article</type><title>Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Balmforth, Damian ; Swales, James A ; Silpa, Laurence ; Dunton, Alan ; Davies, Kay E. ; Davies, Stephen G. ; Kamath, Archana ; Gupta, Jayanti ; Gupta, Sandeep ; Masood, M.Abid ; McKnight, Áine ; Rees, Doug ; Russell, Angela J. ; Jaggi, Manu ; Uppal, Rakesh</creator><creatorcontrib>Balmforth, Damian ; Swales, James A ; Silpa, Laurence ; Dunton, Alan ; Davies, Kay E. ; Davies, Stephen G. ; Kamath, Archana ; Gupta, Jayanti ; Gupta, Sandeep ; Masood, M.Abid ; McKnight, Áine ; Rees, Doug ; Russell, Angela J. ; Jaggi, Manu ; Uppal, Rakesh</creatorcontrib><description>•A randomised control trial of the efficacy of a nasal spray against SARS-CoV-2.•The spray combines natural viricidal agents with mechanisms to prevent viral entry.•The test agent significantly reduced the infection rate from 34.5% to 13.1%.•Fewer patients were symptomatic in the test group [17.6% vs 34.6%; p < 0.0001].•No serious adverse events were reported in either arm of the study.
Background The COVID-19 pandemic continues to devastate communities all over the world. The aim of this study was to evaluate the efficacy and safety of the test agent as a prophylaxis against SARS-CoV-2 infection in a population of high-risk healthcare workers.
Methods The study was a multi-centre, prospective, double blind, randomized, placebo-controlled trial. Key eligibility criteria included absence of significant co-morbidity and no previous SARS-CoV-2 infection or vaccination. Participants were randomised to either the active agent nasal spray or placebo using computer generated random number tables. The nasal spray was administered 3 times daily over a 45 day course. The primary end point was the percentage of subjects who tested positive for IgGS (anti-spike, immunoglobulin G specific to the spike protein of SARS-CoV-2) at day 45.
Results Between 16th April 2021 and 26th July 2021, 556 participants were analysed for the primary endpoint (275 Test; 281 Placebo). The test agent significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs 97 cases (34.5%); OR 0.29 (95% CI; 0.18–0.45), p < 0.0001]. Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27–0.59), p < 0.0001]. No harmful effects were associated with taking the test agent.
Conclusion The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well tolerated and offers a novel treatment option for prophylaxis against SARS-CoV-2 infection.</description><identifier>ISSN: 1386-6532</identifier><identifier>ISSN: 1873-5967</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2022.105248</identifier><identifier>PMID: 35952426</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Clinical trial ; COVID-19 ; COVID-19 - prevention & control ; Humans ; Nasal Sprays ; Pandemics - prevention & control ; Prophylaxis ; Prospective Studies ; SARS-CoV-2</subject><ispartof>Journal of clinical virology, 2022-10, Vol.155, p.105248-105248, Article 105248</ispartof><rights>2022 The Authors</rights><rights>Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.</rights><rights>2022 The Authors 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c451t-6cca0d695199c1d09fa303b0cd7b1bb03801a6ed4a64054eb06d4067584105713</citedby><cites>FETCH-LOGICAL-c451t-6cca0d695199c1d09fa303b0cd7b1bb03801a6ed4a64054eb06d4067584105713</cites><orcidid>0000-0001-8897-7972</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1386653222001809$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35952426$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Balmforth, Damian</creatorcontrib><creatorcontrib>Swales, James A</creatorcontrib><creatorcontrib>Silpa, Laurence</creatorcontrib><creatorcontrib>Dunton, Alan</creatorcontrib><creatorcontrib>Davies, Kay E.</creatorcontrib><creatorcontrib>Davies, Stephen G.</creatorcontrib><creatorcontrib>Kamath, Archana</creatorcontrib><creatorcontrib>Gupta, Jayanti</creatorcontrib><creatorcontrib>Gupta, Sandeep</creatorcontrib><creatorcontrib>Masood, M.Abid</creatorcontrib><creatorcontrib>McKnight, Áine</creatorcontrib><creatorcontrib>Rees, Doug</creatorcontrib><creatorcontrib>Russell, Angela J.</creatorcontrib><creatorcontrib>Jaggi, Manu</creatorcontrib><creatorcontrib>Uppal, Rakesh</creatorcontrib><title>Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>•A randomised control trial of the efficacy of a nasal spray against SARS-CoV-2.•The spray combines natural viricidal agents with mechanisms to prevent viral entry.•The test agent significantly reduced the infection rate from 34.5% to 13.1%.•Fewer patients were symptomatic in the test group [17.6% vs 34.6%; p < 0.0001].•No serious adverse events were reported in either arm of the study.
Background The COVID-19 pandemic continues to devastate communities all over the world. The aim of this study was to evaluate the efficacy and safety of the test agent as a prophylaxis against SARS-CoV-2 infection in a population of high-risk healthcare workers.
Methods The study was a multi-centre, prospective, double blind, randomized, placebo-controlled trial. Key eligibility criteria included absence of significant co-morbidity and no previous SARS-CoV-2 infection or vaccination. Participants were randomised to either the active agent nasal spray or placebo using computer generated random number tables. The nasal spray was administered 3 times daily over a 45 day course. The primary end point was the percentage of subjects who tested positive for IgGS (anti-spike, immunoglobulin G specific to the spike protein of SARS-CoV-2) at day 45.
Results Between 16th April 2021 and 26th July 2021, 556 participants were analysed for the primary endpoint (275 Test; 281 Placebo). The test agent significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs 97 cases (34.5%); OR 0.29 (95% CI; 0.18–0.45), p < 0.0001]. Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27–0.59), p < 0.0001]. No harmful effects were associated with taking the test agent.
Conclusion The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well tolerated and offers a novel treatment option for prophylaxis against SARS-CoV-2 infection.</description><subject>Clinical trial</subject><subject>COVID-19</subject><subject>COVID-19 - prevention & control</subject><subject>Humans</subject><subject>Nasal Sprays</subject><subject>Pandemics - prevention & control</subject><subject>Prophylaxis</subject><subject>Prospective Studies</subject><subject>SARS-CoV-2</subject><issn>1386-6532</issn><issn>1873-5967</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UU1v1DAQjRCIlsIP4IJ85NAsdhw7CUhIq1X5kCohUeBqTexJ1yuvHewk0v4vfiDebqngwsn2zHtvnucVxUtGV4wy-Wa32ullVdGqym9R1e2j4py1DS9FJ5vH-c5bWUrBq7PiWUo7SpngdfO0OOOiy_BKnhe_rhZwM0zW35JpiwSHwWrQBwLekAQDTgcSBgLEhwUdGWMYtwcHerKaeEjgSBojHIj1d_Qx4oJ-ssEfWTfrrzflJvwoq9wfUB_rb8ma7Gc32VJnYMRLYsLcOyS9s95ckjGLYx9KHXI3OIe5FrOZsLcJDZmiBfe8eDKAS_ji_rwovn-4-rb5VF5_-fh5s74udS3YVEqtgRrZCdZ1mhnaDcAp76k2Tc_6nvKWMpBoapA1FTX2VJqayka0dV5nw_hF8f6kO879Hs2dYXBqjHYP8aACWPVvx9utug2L6jjjgvMs8PpeIIafM6ZJ5V9odA48hjmpqqEVa2VbdxnKTlAdQ0oRh4cxjKpj2mqnctrqmLY6pZ05r_7298D4E28GvDsBMG9psRhV0ha9RmNjjkOZYP8j_xtViL23</recordid><startdate>20221001</startdate><enddate>20221001</enddate><creator>Balmforth, Damian</creator><creator>Swales, James A</creator><creator>Silpa, Laurence</creator><creator>Dunton, Alan</creator><creator>Davies, Kay E.</creator><creator>Davies, Stephen G.</creator><creator>Kamath, Archana</creator><creator>Gupta, Jayanti</creator><creator>Gupta, Sandeep</creator><creator>Masood, M.Abid</creator><creator>McKnight, Áine</creator><creator>Rees, Doug</creator><creator>Russell, Angela J.</creator><creator>Jaggi, Manu</creator><creator>Uppal, Rakesh</creator><general>Elsevier B.V</general><general>The Authors. Published by Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8897-7972</orcidid></search><sort><creationdate>20221001</creationdate><title>Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial</title><author>Balmforth, Damian ; Swales, James A ; Silpa, Laurence ; Dunton, Alan ; Davies, Kay E. ; Davies, Stephen G. ; Kamath, Archana ; Gupta, Jayanti ; Gupta, Sandeep ; Masood, M.Abid ; McKnight, Áine ; Rees, Doug ; Russell, Angela J. ; Jaggi, Manu ; Uppal, Rakesh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-6cca0d695199c1d09fa303b0cd7b1bb03801a6ed4a64054eb06d4067584105713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Clinical trial</topic><topic>COVID-19</topic><topic>COVID-19 - prevention & control</topic><topic>Humans</topic><topic>Nasal Sprays</topic><topic>Pandemics - prevention & control</topic><topic>Prophylaxis</topic><topic>Prospective Studies</topic><topic>SARS-CoV-2</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Balmforth, Damian</creatorcontrib><creatorcontrib>Swales, James A</creatorcontrib><creatorcontrib>Silpa, Laurence</creatorcontrib><creatorcontrib>Dunton, Alan</creatorcontrib><creatorcontrib>Davies, Kay E.</creatorcontrib><creatorcontrib>Davies, Stephen G.</creatorcontrib><creatorcontrib>Kamath, Archana</creatorcontrib><creatorcontrib>Gupta, Jayanti</creatorcontrib><creatorcontrib>Gupta, Sandeep</creatorcontrib><creatorcontrib>Masood, M.Abid</creatorcontrib><creatorcontrib>McKnight, Áine</creatorcontrib><creatorcontrib>Rees, Doug</creatorcontrib><creatorcontrib>Russell, Angela J.</creatorcontrib><creatorcontrib>Jaggi, Manu</creatorcontrib><creatorcontrib>Uppal, Rakesh</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Balmforth, Damian</au><au>Swales, James A</au><au>Silpa, Laurence</au><au>Dunton, Alan</au><au>Davies, Kay E.</au><au>Davies, Stephen G.</au><au>Kamath, Archana</au><au>Gupta, Jayanti</au><au>Gupta, Sandeep</au><au>Masood, M.Abid</au><au>McKnight, Áine</au><au>Rees, Doug</au><au>Russell, Angela J.</au><au>Jaggi, Manu</au><au>Uppal, Rakesh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2022-10-01</date><risdate>2022</risdate><volume>155</volume><spage>105248</spage><epage>105248</epage><pages>105248-105248</pages><artnum>105248</artnum><issn>1386-6532</issn><issn>1873-5967</issn><eissn>1873-5967</eissn><abstract>•A randomised control trial of the efficacy of a nasal spray against SARS-CoV-2.•The spray combines natural viricidal agents with mechanisms to prevent viral entry.•The test agent significantly reduced the infection rate from 34.5% to 13.1%.•Fewer patients were symptomatic in the test group [17.6% vs 34.6%; p < 0.0001].•No serious adverse events were reported in either arm of the study.
Background The COVID-19 pandemic continues to devastate communities all over the world. The aim of this study was to evaluate the efficacy and safety of the test agent as a prophylaxis against SARS-CoV-2 infection in a population of high-risk healthcare workers.
Methods The study was a multi-centre, prospective, double blind, randomized, placebo-controlled trial. Key eligibility criteria included absence of significant co-morbidity and no previous SARS-CoV-2 infection or vaccination. Participants were randomised to either the active agent nasal spray or placebo using computer generated random number tables. The nasal spray was administered 3 times daily over a 45 day course. The primary end point was the percentage of subjects who tested positive for IgGS (anti-spike, immunoglobulin G specific to the spike protein of SARS-CoV-2) at day 45.
Results Between 16th April 2021 and 26th July 2021, 556 participants were analysed for the primary endpoint (275 Test; 281 Placebo). The test agent significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs 97 cases (34.5%); OR 0.29 (95% CI; 0.18–0.45), p < 0.0001]. Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27–0.59), p < 0.0001]. No harmful effects were associated with taking the test agent.
Conclusion The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well tolerated and offers a novel treatment option for prophylaxis against SARS-CoV-2 infection.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>35952426</pmid><doi>10.1016/j.jcv.2022.105248</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-8897-7972</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Clinical trial COVID-19 COVID-19 - prevention & control Humans Nasal Sprays Pandemics - prevention & control Prophylaxis Prospective Studies SARS-CoV-2 |
| title | Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial |
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