Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial

{ 'indexed': {'date-parts': [[2022, 12, 9]], 'date-time': '2022-12-09T06:02:43Z', 'timestamp': 1670565763566}, 'reference-count': 26, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2022, 12, 8]], 'date-time': '2022-12-08T00:00:00Z', 'timestamp': 1670457600000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2022, 12, 8]], 'date-time': '2022-12-08T00:00:00Z', 'timestamp': 1670457600000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>Despite the development and application of vaccines against Severe ' 'Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) around the world, the scientific ' 'community is still trying to find some therapies to avoid or ameliorate the fatal evolution ' 'of the Coronavirus disease 2019 (COVID-19). Since the publication of the potential use of ' 'ivermectin as a treatment against the disease, a pleiad of information about it has been ' 'published. However, the evidence is not strong or weak enough to conclude its usefulness in ' 'the clinical evolution of patients infected with SARS-CoV-2. We evaluate the efficacy and ' 'safety of ivermectin in the treatment of Mexican patients with asymptomatic and mild COVID-19 ' 'in a three-day administration in comparison to placebo.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>A randomized, double-blind, placebo-controlled trial was carried out ' 'in 66 adults with asymptomatic and mild COVID-19. Patients were randomly assigned 1:1 ratio ' 'to ivermectin plus acetaminophen or placebo plus acetaminophen. The primary endpoint was the ' 'proportion of subjects without a disease progression to severity according to COVID-19 ' 'guidelines by the National Institutes of Health (NIH) since randomization to 14\xa0' 'days.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>None of the participants presented progression to a severe state in ' 'either group. Viral load was measured on Days 1, 5, and 14. No significant differences were ' 'observed in baseline or 14-day between groups (p\u2009=\u20090.720 and 0.362, respectively). ' 'However, on Day 5, a significant difference in viral load was observed between groups (p\u2009' '=\u20090.039). The frequency of symptoms was similar between groups, and no significant ' 'differences were observed. The most frequent symptom was cough. One severe adverse event ' 'associated with SARS-CoV-2 infection was observed in the ivermectin group.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>At standard doses, ivermectin is not effective to prevent progression ' 'to a severe state or reducing symptoms in adults with asymptomatic and mild ' 'COVID-19.</jats:p>\n' ' <jats:p><jats:italic>Trial registration</jats:italic> The study was ' 'registered with ClinicalTrial.gov (NCT04407507) on May 29, 2020.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s12879-022-07890-6', 'type': 'journal-article', 'created': {'date-parts': [[2022, 12, 8]], 'date-time': '2022-12-08T12:02:59Z', 'timestamp': 1670500979000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic ' 'and mild COVID-19: a randomized clinical trial', 'prefix': '10.1186', 'volume': '22', 'clinical-trial-number': [ { 'clinical-trial-number': 'nct04407507', 'registry': '10.18810/clinical-trials-gov'}], 'author': [ {'given': 'Carmen', 'family': 'de la Rocha', 'sequence': 'first', 'affiliation': []}, {'given': 'Marco A.', 'family': 'Cid-López', 'sequence': 'additional', 'affiliation': []}, {'given': 'Blanca I.', 'family': 'Venegas-López', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sandra C.', 'family': 'Gómez-Méndez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Adriana', 'family': 'Sánchez-Ortiz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alma M.', 'family': 'Pérez-Ríos', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Ricardo A.', 'family': 'Llamas-Velázquez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aidé I.', 'family': 'Meza-Acuña', 'sequence': 'additional', 'affiliation': []}, {'given': 'Bárbara', 'family': 'Vargas-Íñiguez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Daniela', 'family': 'Rosales-Galván', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alejandra', 'family': 'Tavares-Váldez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nizdali', 'family': 'Luna-Gudiño', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Cinthia V.', 'family': 'Hernández-Puente', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jovana', 'family': 'Milenkovic', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Cecilia', 'family': 'Iglesias-Palomares', 'sequence': 'additional', 'affiliation': []}, {'given': 'Miriam', 'family': 'Méndez-del Villar', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Gerardo A.', 'family': 'Gutiérrez-Dieck', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Carlos G.', 'family': 'Valderrábano-Roldán', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jennefer', 'family': 'Mercado-Cerda', 'sequence': 'additional', 'affiliation': []}, { 'given': 'Jocelyn G.', 'family': 'Robles-Bojórquez', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-9025-9328', 'authenticated-orcid': False, 'given': 'Arieh R.', 'family': 'Mercado-Sesma', 'sequence': 'additional', 'affiliation': []}], 'member': '297', 'published-online': {'date-parts': [[2022, 12, 8]]}, 'reference': [ { 'key': '7890_CR1', 'doi-asserted-by': 'publisher', 'first-page': '497', 'DOI': '10.1016/S0140-6736(20)30183-5', 'volume': '395', 'author': 'C Huang', 'year': '2020', 'unstructured': 'Huang C, Wang Y, Li X, et al. 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J Med Virol. 2020;93:206–22.', 'journal-title': 'J Med Virol'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-022-07890-6.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s12879-022-07890-6/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-022-07890-6.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 12, 8]], 'date-time': '2022-12-08T12:03:55Z', 'timestamp': 1670501035000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07890-6'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 12, 8]]}, 'references-count': 26, 'journal-issue': {'issue': '1', 'published-online': {'date-parts': [[2022, 12]]}}, 'alternative-id': ['7890'], 'URL': 'http://dx.doi.org/10.1186/s12879-022-07890-6', 'relation': {}, 'ISSN': ['1471-2334'], 'subject': ['Infectious Diseases'], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2022, 12, 8]]}, 'assertion': [ { 'value': '13 May 2022', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '21 November 2022', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '8 December 2022', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'The protocol was approved by the local ethics, biosafety and investigation ' 'committees and the Mexican health ministry COFEPRIS: 203301410A0055. The study ' 'is registered on ClinicalTrials.gov: NCT04407507. Patients gave their written ' 'consent prior the participation on the study and informed consent was obtained ' 'from all the participants.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'The authors declare that they have no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '917'}