Efficacy and safety of ivermectin in the treatment of mild-to-moderate COVID-19 infection: A randomized, double blind, placebo, controlled trial

DOI record: { "DOI": "10.1186/s13063-022-06649-3", "ISSN": [ "1745-6215" ], "URL": "http://dx.doi.org/10.1186/s13063-022-06649-3", "abstract": "<jats:title>Abstract</jats:title><jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pandemic. Ivermectin is an antiparasitic drug that has shown effectiveness against various agents, including SARS-CoV-2. This study aimed to assess the efficacy of ivermectin treatment compared with the standard of care (SOC) among people with mild to moderate COVID-19 symptoms.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>In this randomized, double-blind, placebo-controlled, single-center, parallel-arm, superiority trial among adult hospitalized patients with mild to moderate COVID-19, 72 patients (mean age 48.57 ± 14.80 years) were randomly assigned to either the ivermectin (<jats:italic>n</jats:italic>=36) or placebo (<jats:italic>n</jats:italic>=36) group, along with receiving standard care. We aimed to compare the negativity of reverse transcription polymerase chain reaction (RT-PCR) result at days 7 and 14 of enrolment as the primary outcome. The secondary outcomes were duration of hospitalization, frequency of clinical worsening, survival on day 28, and adverse events.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>At days 7 and 14, no differences were observed in the proportion of PCR-positive patients (RR 0.97 at day 7 (<jats:italic>p</jats:italic>=0.759) and 0.95 at day 14 (<jats:italic>p</jats:italic>=0.813). No significant differences were found between the groups for any of the secondary endpoints, and no adverse events were reported.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Conclusion</jats:title>\n <jats:p>No difference was found in the proportion of PCR-positive cases after treatment with ivermectin compared with standard care among patients with mild to moderate COVID-19 symptoms. However, early symptomatic recovery was observed without side effects.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Trial registration</jats:title>\n <jats:p>ClinicalTrials.gov NCT05076253. Registered on 8 October 2021, prospectively.</jats:p>\n </jats:sec>", "alternative-id": [ "6649" ], "article-number": "714", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "23 February 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "7 August 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "26 August 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 study was conducted according to the guidelines of the Declaration of Helsinki and Good Clinical Practice Guidelines. The trial was approved by the Vajira Ethics Committee, approval no 171/64. Written informed consent was obtained from all subjects involved in the study." }, { "group": { "label": "Consent for publication", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "Consent for publication is not applicable." }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 4, "value": "The authors declare they have no competing interests." } ], "author": [ { "affiliation": [], "family": "Manomaipiboon", "given": "Anan", "sequence": "first" }, { "affiliation": [], "family": "Pholtawornkulchai", "given": "Kittisak", "sequence": "additional" }, { "affiliation": [], "family": "Poopipatpab", "given": "Sujaree", "sequence": "additional" }, { "affiliation": [], "family": "Suraamornkul", "given": "Swangjit", "sequence": "additional" }, { "affiliation": [], "family": "Maneerit", "given": "Jakravoot", "sequence": "additional" }, { "affiliation": [], "family": "Ruksakul", "given": "Wiroj", "sequence": "additional" }, { "affiliation": [], "family": "Phumisantiphong", "given": "Uraporn", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-4374-251X", "affiliation": [], "authenticated-orcid": false, "family": "Trakarnvanich", "given": "Thananda", "sequence": "additional" } ], "container-title": "Trials", "container-title-short": "Trials", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2022, 8, 26 ] ], "date-time": "2022-08-26T12:02:55Z", "timestamp": 1661515375000 }, "deposited": { "date-parts": [ [ 2022, 8, 26 ] ], "date-time": "2022-08-26T12:19:00Z", "timestamp": 1661516340000 }, "funder": [ { "award": [ "171/64" ], "name": "Navamindradhiraj University" } ], "indexed": { "date-parts": [ [ 2022, 8, 26 ] ], "date-time": "2022-08-26T12:43:06Z", "timestamp": 1661517786061 }, "is-referenced-by-count": 0, "issue": "1", "issued": { "date-parts": [ [ 2022, 8, 26 ] ] }, "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, 8, 26 ] ], "date-time": "2022-08-26T00:00:00Z", "timestamp": 1661472000000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2022, 8, 26 ] ], "date-time": "2022-08-26T00:00:00Z", "timestamp": 1661472000000 } } ], "link": [ { "URL": "https://link.springer.com/content/pdf/10.1186/s13063-022-06649-3.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/article/10.1186/s13063-022-06649-3/fulltext.html", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/content/pdf/10.1186/s13063-022-06649-3.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1186", "published": { "date-parts": [ [ 2022, 8, 26 ] ] }, "published-online": { "date-parts": [ [ 2022, 8, 26 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "key": "6649_CR1", "unstructured": "COVID-19 dashboard. 2021. https://coronavirus.jhu.edu/map.html. 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