{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T14:31:07Z","timestamp":1777645867719,"version":"3.51.4"},"reference-count":39,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"SaluGenics"},{"name":"H&S Ventures and Biosimilia funded the project"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Global Advances in Integrative Medicine and Health"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>This study investigated a potentized, oral homeopathic SARS-CoV-2 nosode (BiosimCovex) for safety, efficacy, and immunogenicity against COVID-19 infection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A phase III, multicentre, randomised, double-blind, placebo-controlled trial was conducted at 13 sites in India. 2671 unvaccinated, RT-PCR and SARS-CoV-2 antibody-negative participants were randomized 2:1 to receive 6 doses over 3 days of BiosimCovex (1781) or placebo (890). SARS-CoV-2 prevention efficacy was assessed through RT-PCR. Efficacy was defined as 100 x (1-IRR), where IRR is the ratio of positive RT-PCR test rates in the BiosimCovex compared to the placebo group. A two-sided Clopper-Pearson 95% confidence interval was adjusted for surveillance time. Immunogenicity was measured by SARS-CoV-2 antibody conversion at days 15, 30, 45, and 60. Safety was assessed through symptom questionnaires and laboratory studies every 15 days. Illness burden was assessed through symptom diaries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Maximum efficacy occurred at day 45 and was 50.06% overall, 71.88% in individuals aged 18-40 years; and 61.57% in females. By day 45, there were 23 positive RT-PCR cases per group (BiosimCovex 1.3%; placebo 2.6%,\n                      <jats:italic>P<\/jats:italic>\n                      = 0.007). A total of fifty-nine positive RT-PCR cases occurred, with thirty-three (1.86%) in the BiosimCovex and twenty-six (2.94%) in the placebo group, for a relative risk (RR) of 0.63 at the end of the study over 60 days. Antibody conversion increased over time, with 48.4% becoming antibody positive by day 60 in the treatment group compared to 13.4% in the placebo group (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001). All 169 (6.33%) mild adverse events resolved without sequelae (6.52% in treatment; 5.96% in placebo). There was a significant reduction in symptom duration (\n                      <jats:italic>P<\/jats:italic>\n                      = 0.0085) in the treatment group for those who became ill.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A potentized oral nosode was safe and appeared to prevent SARS-CoV-2 infection and be immunogenic over 60 days. Effectiveness was highest at day 45 in females and in the 18- to 40-year-old age group.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/27536130251386048","type":"journal-article","created":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T20:34:21Z","timestamp":1759782861000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Protection From SARS-CoV-2 Infection With an Oral Nosode (BiosimCovex): A Randomized, Double-Blind, Placebo-Controlled, Phase III Study"],"prefix":"10.1177","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1263-9077","authenticated-orcid":false,"given":"Rajesh","family":"Shah","sequence":"first","affiliation":[{"name":"Department of Research, Biosimilia Private Limited, Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-2215-6973","authenticated-orcid":false,"given":"Gitanjali","family":"Talele","sequence":"additional","affiliation":[{"name":"Department of Research, Biosimilia Private Limited, Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5158-9893","authenticated-orcid":false,"given":"Joan","family":"Walter","sequence":"additional","affiliation":[{"name":"Samueli Integrative Health Programs, Silver Spring, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-6851-205X","authenticated-orcid":false,"given":"John A.","family":"Ives","sequence":"additional","affiliation":[{"name":"Samueli Institute, Alexandria, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4248-3878","authenticated-orcid":false,"given":"Jessica","family":"Utts","sequence":"additional","affiliation":[{"name":"Department of Statistics, University of California, Irvine, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shubhada","family":"Chiplunkar","sequence":"additional","affiliation":[{"name":"ACTREC, Tata Memorial Centre, Navi Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8498-3849","authenticated-orcid":false,"given":"Wayne B.","family":"Jonas","sequence":"additional","affiliation":[{"name":"Georgetown University and Uniformed Services University, Alexandria, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,10,6]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.22759"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/ecam\/neh141"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.4103\/0974-7168.141740"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.joim.2024.06.005"},{"issue":"3","key":"e_1_3_6_6_2","first-page":"107","article-title":"Biophysical techniques revealed insight of potentized solvent of ethanol-water interface","volume":"31","author":"Pal P","year":"2021","unstructured":"Pal P, Talale G, Dongre P, et al. 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