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

DOI record: { "DOI": "10.1186/s12879-022-07890-6", "ISSN": [ "1471-2334" ], "URL": "http://dx.doi.org/10.1186/s12879-022-07890-6", "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 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 = 0.720 and 0.362, respectively). However, on Day 5, a significant difference in viral load was observed between groups (p = 0.039). 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>", "alternative-id": [ "7890" ], "article-number": "917", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "13 May 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "21 November 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "8 December 2022" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Ethics approval and consent to participate", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "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." }, { "group": { "label": "Consent for publication", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "Not applicable." }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 4, "value": "The authors declare that they have no competing interests." } ], "author": [ { "affiliation": [], "family": "de la Rocha", "given": "Carmen", "sequence": "first" }, { "affiliation": [], "family": "Cid-López", "given": "Marco A.", "sequence": "additional" }, { "affiliation": [], "family": "Venegas-López", "given": "Blanca I.", "sequence": "additional" }, { "affiliation": [], "family": "Gómez-Méndez", "given": "Sandra C.", "sequence": "additional" }, { "affiliation": [], "family": "Sánchez-Ortiz", "given": "Adriana", "sequence": "additional" }, { "affiliation": [], "family": "Pérez-Ríos", "given": "Alma M.", "sequence": "additional" }, { "affiliation": [], "family": "Llamas-Velázquez", "given": "Ricardo A.", "sequence": "additional" }, { "affiliation": [], "family": "Meza-Acuña", "given": "Aidé I.", "sequence": "additional" }, { "affiliation": [], "family": "Vargas-Íñiguez", "given": "Bárbara", "sequence": "additional" }, { "affiliation": [], "family": "Rosales-Galván", "given": "Daniela", "sequence": "additional" }, { "affiliation": [], "family": "Tavares-Váldez", "given": "Alejandra", "sequence": "additional" }, { "affiliation": [], "family": "Luna-Gudiño", "given": "Nizdali", "sequence": "additional" }, { "affiliation": [], "family": "Hernández-Puente", "given": "Cinthia V.", "sequence": "additional" }, { "affiliation": [], "family": "Milenkovic", "given": "Jovana", "sequence": "additional" }, { "affiliation": [], "family": "Iglesias-Palomares", "given": "Cecilia", "sequence": "additional" }, { "affiliation": [], "family": "Méndez-del Villar", "given": "Miriam", "sequence": "additional" }, { "affiliation": [], "family": "Gutiérrez-Dieck", "given": "Gerardo A.", "sequence": "additional" }, { "affiliation": [], "family": "Valderrábano-Roldán", "given": "Carlos G.", "sequence": "additional" }, { "affiliation": [], "family": "Mercado-Cerda", "given": "Jennefer", "sequence": "additional" }, { "affiliation": [], "family": "Robles-Bojórquez", "given": "Jocelyn G.", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-9025-9328", "affiliation": [], "authenticated-orcid": false, "family": "Mercado-Sesma", "given": "Arieh R.", "sequence": "additional" } ], "clinical-trial-number": [ { "clinical-trial-number": "nct04407507", "registry": "10.18810/clinical-trials-gov" } ], "container-title": "BMC Infectious Diseases", "container-title-short": "BMC Infect Dis", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2022, 12, 8 ] ], "date-time": "2022-12-08T12:02:59Z", "timestamp": 1670500979000 }, "deposited": { "date-parts": [ [ 2022, 12, 8 ] ], "date-time": "2022-12-08T12:03:55Z", "timestamp": 1670501035000 }, "indexed": { "date-parts": [ [ 2022, 12, 9 ] ], "date-time": "2022-12-09T06:02:43Z", "timestamp": 1670565763566 }, "is-referenced-by-count": 0, "issue": "1", "issued": { "date-parts": [ [ 2022, 12, 8 ] ] }, "journal-issue": { "issue": "1", "published-online": { "date-parts": [ [ 2022, 12 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2022, 12, 8 ] ], "date-time": "2022-12-08T00:00:00Z", "timestamp": 1670457600000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2022, 12, 8 ] ], "date-time": "2022-12-08T00:00:00Z", "timestamp": 1670457600000 } } ], "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" } ], "member": "297", "original-title": [], "prefix": "10.1186", "published": { "date-parts": [ [ 2022, 12, 8 ] ] }, "published-online": { "date-parts": [ [ 2022, 12, 8 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "DOI": "10.1016/S0140-6736(20)30183-5", "author": "C Huang", "doi-asserted-by": "publisher", "first-page": "497", "journal-title": "Lancet", "key": "7890_CR1", "unstructured": "Huang C, Wang Y, Li X, et al. 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