{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:41:41Z","timestamp":1772160101699,"version":"3.50.1"},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,2,27]],"date-time":"2022-02-27T00:00:00Z","timestamp":1645920000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The RD\u2010X19 is an investigational, handheld medical device precisely engineered to emit blue light through the oral cavity to target the oropharynx and surrounding tissues. At doses shown to be noncytotoxic in an in vitro three\u2010dimensional human epithelial tissue model, the monochromatic visible light delivered by RD\u2010X19 results in light\u2010initiated expression of immune stimulating cytokines IL\u20101\u03b1 and IL\u20101\u03b2, with corresponding inhibition of severe acute respiratory syndrome\u2010coronavirus 2 (SARS\u2010CoV\u20102) replication. A single exposure of 425\u00a0nm blue light at 60\u00a0J\/cm\n                    <jats:sup>2<\/jats:sup>\n                    led to greater than 99% reductions against all SARS\u2010CoV\u20102 strains tested in vitro, including the more transmissible (Alpha) and immune evasive (Beta) variants. These preclinical findings along with other studies led to a randomized, double\u2010blind, sham\u2010controlled early feasibility study using the investigational device as a treatment for outpatients with mild to moderate coronavirus disease 2019 (COVID\u201019). The study enrolled 31 subjects with a positive SARS\u2010CoV\u20102 antigen test and at least two moderate COVID\u201019 signs and symptoms at baseline. Subjects were randomized 2:1 (RD\u2010X19: sham) and treated twice daily for 4 days. Efficacy outcome measures included assessments of SARS\u2010CoV\u20102 saliva viral load and clinical assessments of COVID\u201019. There were no local application site reactions and no device\u2010related adverse events. At the end of the study (day 8), the mean change in log\n                    <jats:sub>10<\/jats:sub>\n                    viral load was \u22123.29 for RD\u2010X19 and \u22121.81 for sham, demonstrating a treatment benefit of \u22121.48\u00a0logs (95% confidence internal, \u22122.88 to \u22120.071, nominal\n                    <jats:italic>p\u00a0<\/jats:italic>\n                    =\u00a00.040). Among the clinical outcome measures, differences between RD\u2010X19 and sham were also observed, with a 57\u2010h reduction of median time to sustained resolution of COVID\u201019 signs and symptoms (log rank test, nominal\n                    <jats:italic>p\u00a0<\/jats:italic>\n                    =\u00a00.044).\n                  <\/jats:p>","DOI":"10.1111\/cts.13249","type":"journal-article","created":{"date-parts":[[2022,2,9]],"date-time":"2022-02-09T01:49:27Z","timestamp":1644371367000},"page":"1291-1303","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A randomized, controlled, feasibility study of RD\u2010X19 in subjects with mild\u2010to\u2010moderate COVID\u201019 in the outpatient setting"],"prefix":"10.1111","volume":"15","author":[{"given":"Nathan","family":"Stasko","sequence":"first","affiliation":[{"name":"EmitBio Inc  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam S.","family":"Cockrell","sequence":"additional","affiliation":[{"name":"EmitBio Inc  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacob F.","family":"Kocher","sequence":"additional","affiliation":[{"name":"EmitBio Inc  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ibrahim","family":"Henson","sequence":"additional","affiliation":[{"name":"EmitBio Inc  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Emerson","sequence":"additional","affiliation":[{"name":"EmitBio Inc  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ye","family":"Wang","sequence":"additional","affiliation":[{"name":"Symbio, LLC  Port Jefferson New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan R.","family":"Smith","sequence":"additional","affiliation":[{"name":"Adaptive Plus, LLC  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathan H.","family":"Henderson","sequence":"additional","affiliation":[{"name":"MRIGlobal  Kansas City Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hillary","family":"Wood","sequence":"additional","affiliation":[{"name":"MRIGlobal  Kansas City Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shelton S.","family":"Bradrick","sequence":"additional","affiliation":[{"name":"MRIGlobal  Kansas City Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terry","family":"Jones","sequence":"additional","affiliation":[{"name":"J&amp;S Studies, Inc  College Station Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Santander","sequence":"additional","affiliation":[{"name":"APF Research International, LLC  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John\u00a0G.","family":"McNeil","sequence":"additional","affiliation":[{"name":"EmitBio Inc  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,2,27]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2016359"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1101\/2021.01.04.21249236v2"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30196-1"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41368-020-0074-x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01296-8"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.0202"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2035002"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2033700"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.29058"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcibr2032888"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.2294"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01294-w"},{"key":"e_1_2_10_14_1","first-page":"41","article-title":"Low\u2010level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring","volume":"32","author":"Avci P","year":"2013","journal-title":"Semin Cutan Med Surg"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1089\/photob.2020.4905"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/php.12864"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbio.202000496"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-99917-2"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.micpath.2010.11.009"},{"key":"e_1_2_10_20_1","volume-title":"COVID\u201019: Developing Drugs and Biological Products for Treatment or Prevention","author":"U.S. Food and Drug Administration","year":"2021"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/srep33847"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/JPER.21-0277"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-020-19057-5"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2020.613170"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.79.10.6441-6448.2005"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.03006-2020"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1011-1344(98)00118-3"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.molcel.2018.07.009"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.csbj.2021.07.023"},{"key":"e_1_2_10_30_1","volume-title":"Fact Sheet for Healthcare Providers: Emergency Use Authorization for REGEN\u2010COV\u00ae (casirivimab and imdevimab)","author":"Regeneron"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciab912"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1716197"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g2545"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.22813"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13249","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.13249","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13249","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,23]],"date-time":"2023-08-23T23:53:30Z","timestamp":1692834810000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.13249"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2,27]]},"references-count":33,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2022,5]]}},"alternative-id":["10.1111\/cts.13249"],"URL":"https:\/\/doi.org\/10.1111\/cts.13249","archive":["Portico"],"relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2021.10.17.21265058","asserted-by":"object"}]},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2,27]]},"assertion":[{"value":"2021-10-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-26","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}