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Ivermectin Role in COVID-19 Treatment (IRICT): single center, adaptive, randomized, double-blind, placebo controlled, clinical trial

Elshafie et al., Expert Review of Anti-infective Therapy, doi:10.1080/14787210.2022.2098113, NCT04746365
Jul 2022  
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Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020
 
*, now with p < 0.00000000001 from 104 studies, recognized in 22 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19ivm.org
This study was retracted due to data integrity and validity concerns1. Data in this study was anomalous, for example at day 14 ivermectin simultaneously showed 4x greater chance of recovery and 26x greater mortality. Figure 3 showed identical curves for ivermectin and placebo which does not match the data.
Study covers ivermectin and HCQ.
Elshafie et al., 4 Jul 2022, Double Blind Randomized Controlled Trial, placebo-controlled, peer-reviewed, 9 authors, study period 24 December, 2020 - 31 January, 2021, average treatment delay 7.58 days, trial NCT04746365 (history).
This PaperIvermectinAll
Ivermectin role in COVID-19 treatment (IRICT): single-center, adaptive, randomized, double-blind, placebo-controlled, clinical trial
Ahmed Hanei Elshafie, Hozaifa Khalil Elsawah, Mohamed Hammad, Eman Mohamed Sweed, Ahmed Salah Seif, Muhammad Mostafa Abdel Ghaffar, Feisal Mahmoud Goda, Esraa M Mosalam, Mahmoud S Abdallah
Expert Review of Anti-infective Therapy, doi:10.1080/14787210.2022.2098113
Background: To investigate the efficacy and safety of ivermectin compared to hydroxychloroquine and placebo in hospitalized moderate to severe COVID-19 patients. Research design and methods: The study was an adaptive, randomized, double-blinded, controlled, single-center trial. The study was a series of 3-arm comparisons between two different investigational therapeutic agents (ivermectin and hydroxychloroquine) and a placebo. There was interim monitoring to allow early stopping for futility, efficacy, or safety. Results: Ivermectin decreased survival time from 29 to 18.3 days (HR, 9.8, 95%CI, 3.7-26.2), while it did not shorten the recovery time (HR, 1.02, 95%CI, 0.69-1.5). Subgroup analysis showed an association between ivermectin-related mortality and baseline oxygen saturation level. Moreover, stratified groups showed higher risk among patients on high flow O2. Hydroxychloroquine delayed recovery from 10.1 to 12.5 days (HR, 0.62, 95%CI, 0.4-0.95) and non-significantly decreased survival time from 29 to 26.8 days (HR, 1.47, 95%CI, 0.73-2.9). However, 3 months mortality rates were increased with hydroxychloroquine (RR, 2.05, 95%CI,). Neither ivermectin nor hydroxychloroquine increased adverse events and demonstrated safety profile compared to placebo. Conclusions: The study recommends against using either ivermectin or hydroxychloroquine for treatment of COVID-19 in hospitalized patients with any degree of severity. Clinical trial registration: www. clinicaltrials.gov identifier is: NCT04746365.
Declaration of interests The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Reviewer disclosures Peer reviewers on this manuscript have no relevant financial or other relationships to disclose. Author contributions Ahmed Hanei Elshafie, Hozaifa Khalil Elsawah, Eman Mohamed Sweed, Muhammad Mostafa Abdel Ghaffar and Esraa M Mosalam, and Mahmoud S. Abdallah contributed to study conception, design, data and statistical analysis and interpretation, writing, and critically reviewed the manuscript; Mohamed Hammad, Ahmed Salah Seif, and Feisal Mahmoud Goda: Contributed to data collection, analysis, and interpretation, as well as drafting and substantially revising the manuscript. All authors have agreed on the journal to which the article submitted, reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage, and agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.
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Journal of ' 'antimicrobial chemotherapy. 1994;34(2):195-203.', 'DOI': '10.1093/jac/34.2.195'}, { 'key': 'cit0041', 'unstructured': '41.\tMerck Statement on Ivermectin use During the COVID-19 Pandemic 2021 ' '[cited 2021 June]. Available from: ' 'https://www.merck.com/news/merck-statement-on-ivermectin-use-during-the-covid-19-pandemic/'}, { 'key': 'cit0042', 'unstructured': '42.\tPLAQUENIL: Sanofi 2017 [cited 2021 June]. Available from: ' 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf'}, { 'key': 'cit0043', 'doi-asserted-by': 'crossref', 'unstructured': '43.\tReardon S. Flawed ivermectin preprint highlights challenges of ' 'COVID drug studies. Nature. 2021;596(7871):173-174.', 'DOI': '10.1038/d41586-021-02081-w'}, { 'key': 'cit0044', 'unstructured': '44.\tAdministration FDA. Why You Should Not Use Ivermectin to Treat or ' 'Prevent COVID-19? 2021 [cited 2021 12/8/2021]. Available from: ' 'https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19'}, { 'key': 'cit0045', 'doi-asserted-by': 'crossref', 'unstructured': '45.\tPeña‐Silva R, Duffull SB, Steer AC, et al. Pharmacokinetic ' 'considerations on the repurposing of ivermectin for treatment of ' 'COVID‐19. British Journal of Clinical Pharmacology. 2020.', 'DOI': '10.1111/bcp.14476'}, { 'key': 'cit0046', 'doi-asserted-by': 'crossref', 'unstructured': '46.\tDuenas-Gonzalez A. The pharmacokinetic rationale of Ivermectin for ' 'COVID-19 therapy. Authorea Preprints. 2021.', 'DOI': '10.22541/au.163513079.90720371/v1'}], 'container-title': 'Expert Review of Anti-infective Therapy', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.tandfonline.com/doi/pdf/10.1080/14787210.2022.2098113', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 7, 5]], 'date-time': '2022-07-05T06:51:59Z', 'timestamp': 1657003919000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.tandfonline.com/doi/full/10.1080/14787210.2022.2098113'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 7, 4]]}, 'references-count': 46, 'alternative-id': ['10.1080/14787210.2022.2098113'], 'URL': 'http://dx.doi.org/10.1080/14787210.2022.2098113', 'relation': {}, 'ISSN': ['1478-7210', '1744-8336'], 'subject': ['Virology', 'Infectious Diseases', 'Microbiology (medical)', 'Microbiology'], 'container-title-short': 'Expert Review of Anti-infective Therapy', 'published': {'date-parts': [[2022, 7, 4]]}, 'assertion': [ { 'value': 'The publishing and review policy for this title is described in its Aims & ' 'Scope.', 'order': 1, 'name': 'peerreview_statement', 'label': 'Peer Review Statement'}, { 'value': 'http://www.tandfonline.com/action/journalInformation?show=aimsScope&journalCode=ierz20', 'URL': 'http://www.tandfonline.com/action/journalInformation?show=aimsScope&journalCode=ierz20', 'order': 2, 'name': 'aims_and_scope_url', 'label': 'Aim & Scope'}, { 'value': '2021-11-12', 'order': 0, 'name': 'received', 'label': 'Received', 'group': {'name': 'publication_history', 'label': 'Publication History'}}, { 'value': '2022-05-04', 'order': 1, 'name': 'revised', 'label': 'Revised', 'group': {'name': 'publication_history', 'label': 'Publication History'}}, { 'value': '2022-06-17', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'publication_history', 'label': 'Publication History'}}, { 'value': '2022-07-04', 'order': 3, 'name': 'published', 'label': 'Published', 'group': {'name': 'publication_history', 'label': 'Publication History'}}]}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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