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All Studies   Meta Analysis    Recent:   

Evaluation of the Effectiveness and Safety of Adding Ivermectin to Treatment in Severe COVID-19 Patients

Okumuş et al., BMC Infectious Diseases, doi:10.1186/s12879-021-06104-9 (date from preprint), NCT04646109
Jan 2021  
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Mortality 33% Improvement Relative Risk Improvement at day 10 43% Improvement at day 5 16% primary Viral clearance 80% Ivermectin  Okumuş et al.  LATE TREATMENT  DB RCT Is late treatment with ivermectin beneficial for COVID-19? Double-blind RCT 60 patients in Turkey (May - September 2020) Improved viral clearance with ivermectin (p=0.021) c19ivm.org Okumuş et al., BMC Infectious Diseases, Jan 2021 Favorsivermectin Favorscontrol 0 0.5 1 1.5 2+
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
Small RCT for severe COVID-19 comparing the addition of ivermectin to SOC (low dose HCQ+AZ+favipiravir), with 30 treatment and 30 control patients in Turkey, showing lower mortality and faster clinical recovery. Authors also investigate the presence of gene mutations that alter ivermectin metabolism, predicting that ivermectin can be used safely without serious side effects in patients without MDR-1/ABCB1 and/or CYP3A4 gene mutation, and recommending monitoring and appropriate treatment if necessary when sequencing is unavailable. NCT04646109 (history).
This is the 13th of 51 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000015.
This is the 32nd of 104 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 1 sextillion).
risk of death, 33.3% lower, RR 0.67, p = 0.55, treatment 6 of 30 (20.0%), control 9 of 30 (30.0%), NNT 10.
risk of no improvement at day 10, 42.9% lower, RR 0.57, p = 0.18, treatment 8 of 30 (26.7%), control 14 of 30 (46.7%), NNT 5.0.
risk of no improvement at day 5, 15.8% lower, RR 0.84, p = 0.60, treatment 16 of 30 (53.3%), control 19 of 30 (63.3%), NNT 10, primary outcome.
risk of no viral clearance, 80.0% lower, RR 0.20, p = 0.02, treatment 2 of 16 (12.5%), control 5 of 8 (62.5%), NNT 2.0, day 10.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Okumuş et al., 12 Jan 2021, Double Blind Randomized Controlled Trial, Turkey, peer-reviewed, 15 authors, study period May 2020 - September 2020, dosage 200μg/kg days 1-5, 36-50kg - 9mg, 51-65kg - 12mg, 66-79kg - 15mg, >80kg 200μg/kg, trial NCT04646109 (history).
This PaperIvermectinAll
Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patients
Nurullah Okumuş, Neşe Demirtürk, Rıza Aytaç Çetinkaya, Rahmet Güner, İsmail Yaşar Avcı, Semiha Orhan, Petek Konya, Bengü Şaylan, Ayşegül Karalezli, Levent Yamanel, Bircan Kayaaslan, Gülden Yılmaz, Ümit Savaşçı, Fatma Eser, Gürhan Taşkın
BMC Infectious Diseases, doi:10.1186/s12879-021-06104-9
Background and objectives: An effective treatment option is not yet available for SARS-CoV2, which causes the COVID-19 pandemic and whose effects are felt more and more every day. Ivermectin is among the drugs whose effectiveness in treatment has been investigated. In this study; it was aimed to investigate the presence of gene mutations that alter ivermectin metabolism and cause toxic effects in patients with severe COVID-19 pneumonia, and to evaluate the effectiveness and safety of ivermectin use in the treatment of patients without mutation. Materials and methods: Patients with severe COVID19 pneumonia were included in the study, which was planned as a prospective, randomized, controlled, single-blind phase 3 study. Two groups, the study group and the control group, took part in the study. Ivermectin 200 mcg/kg/day for 5 days in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine + favipiravir + azithromycin-of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin. The presence of mutations was investigated by performing sequence analysis in the mdr1/ abcab1 gene with the Sanger method in patients included in the study group according to randomization. Patients with mutations were excluded from the study and ivermectin treatment was not continued. Patients were followed for 5 days after treatment. At the end of the treatment and follow-up period, clinical response and changes in laboratory parameters were evaluated.
Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s12879-021-06104-9. Additional file 1: Supplementary Table 1 . Laboratory parameter changes. Declarations Ethics approval and consent to participate Ethics board approval (Afyonkarahisar Health Science University, Local Ethical Commitee 03.04.2020/139). All participants provided informed consent prior to study enrollment. Consent for publication Not applicable. Competing interests The authors declare that they have neither financial nor non-financial competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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' 'Ivermectin is among the drugs whose effectiveness in treatment has been investigated. In this ' 'study; it was aimed to investigate the presence of gene mutations that alter ivermectin ' 'metabolism and cause toxic effects in patients with severe COVID-19 pneumonia, and to ' 'evaluate the effectiveness and safety of ivermectin use in the treatment of patients without ' 'mutation.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Materials and methods</jats:title>\n' ' <jats:p>Patients with severe COVID19 pneumonia were included in the study, ' 'which was planned as a prospective, randomized, controlled, single-blind phase 3 study. Two ' 'groups, the study group and the control group, took part in the study. Ivermectin 200 ' 'mcg/kg/day for 5 days in the form of a solution prepared for enteral use added to the ' 'reference treatment protocol -hydroxychloroquine + favipiravir + azithromycin- of patients ' 'included in the study group. Patients in the control group were given only reference ' 'treatment with 3 other drugs without ivermectin. The presence of mutations was investigated ' 'by performing sequence analysis in the <jats:italic>mdr1/abcab1</jats:italic> gene with the ' 'Sanger method in patients included in the study group according to randomization. Patients ' 'with mutations were excluded from the study and ivermectin treatment was not continued. ' 'Patients were followed for 5\u2009days after treatment. At the end of the treatment and ' 'follow-up period, clinical response and changes in laboratory parameters were ' 'evaluated.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A total of 66 patients, 36 in the study group and 30 in the control ' 'group were included in the study. Mutations affecting ivermectin metabolism was detected in ' 'genetic tests of six (16.7%) patients in the study group and they were excluded from the ' 'study. At the end of the 5-day follow-up period, the rate of clinical improvement was 73.3% ' '(22/30) in the study group and was 53.3% (16/30) in the control group (<jats:italic>p\u2009' '=\u20090.10</jats:italic>). At the end of the study, mortality developed in 6 patients (20%) ' 'in the study group and in 9 (30%) patients in the control group (<jats:italic>p\u2009=\u2009' '0.37</jats:italic>). At the end of the follow-up period, the average peripheral capillary ' 'oxygen saturation (SpO2) values of the study and control groups were found to be 93.5 and ' '93.0%, respectively. Partial pressure of oxygen (PaO2)/FiO2 ratios were determined as ' '236.3\u2009±\u200985.7 and 220.8\u2009±\u2009127.3 in the study and control groups, ' 'respectively. While the blood lymphocyte count was higher in the study group compared to the ' 'control group (1698\u2009±\u20091438 and 1256\u2009±\u2009710, respectively) at the end of ' 'the follow-up period (<jats:italic>p\u2009=\u20090.24</jats:italic>); reduction in serum ' 'C-reactive protein (CRP), ferritin and D-dimer levels was more pronounced in the study group ' '(<jats:italic>p\u2009=\u20090.02, p\u2009=\u20090.005 and p\u2009=\u20090.03</jats:italic>, ' 'respectively).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>According to the findings obtained, ivermectin can provide an ' 'increase in clinical recovery, improvement in prognostic laboratory parameters and a decrease ' 'in mortality rates even when used in patients with severe COVID-19. 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Eur Rev Med Pharmacol ' 'Sci. 2020;24(8):4539–47. https://doi.org/10.26355/eurrev_202004_21038.', 'journal-title': 'Eur Rev Med Pharmacol Sci'}, { 'issue': '19', 'key': '6104_CR17', 'doi-asserted-by': 'publisher', 'first-page': '1787', 'DOI': '10.1056/NEJMoa2001282', 'volume': '382', 'author': 'B Cao', 'year': '2020', 'unstructured': 'Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, et al. A trial of ' 'lopinavir-ritonavir in adults in hospitalized with severe Covid-19. ' 'NEJM. 2020;382(19):1787–99. https://doi.org/10.1056/NEJMoa2001282.', 'journal-title': 'NEJM'}, { 'issue': '19', 'key': '6104_CR18', 'doi-asserted-by': 'publisher', 'first-page': '1813', 'DOI': '10.1056/NEJMoa2007764', 'volume': '383', 'author': 'JH Beigel', 'year': '2020', 'unstructured': 'Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. ' 'Remdesivir for the treatment of Covid-19. Final report. N Engl J Med. 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Eur J ' 'Intern Med. 2020;76:31–5. https://doi.org/10.1016/j.ejim.2020.05.009.', 'journal-title': 'Eur J Intern Med'}, { 'key': '6104_CR23', 'doi-asserted-by': 'publisher', 'first-page': '100684', 'DOI': '10.1016/j.nmni.2020.100684', 'volume': '35', 'author': 'R Choudhary', 'year': '2020', 'unstructured': 'Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin ' 'and azithromycin drugs in fighting COVID-19: trends, scope and ' 'relevance. New Microbes New Infect. 2020;35:100684. ' 'https://doi.org/10.1016/j.nmni.2020.100684 PMID: 32322397; PMCID: ' 'PMC7175902.', 'journal-title': 'New Microbes New Infect'}, { 'issue': '4', 'key': '6104_CR24', 'doi-asserted-by': 'publisher', 'first-page': '213', 'DOI': '10.1016/j.pulmoe.2020.04.013', 'volume': '26', 'author': 'JC Winck', 'year': '2020', 'unstructured': 'Winck JC, Ambrosino N. COVID-19 pandemic and noninvasive respiratory ' 'management: every goliath needs a David: an evidence based evaluation of ' 'problems. Pulmonology. 2020;26(4):213–20. ' 'https://doi.org/10.1016/j.pulmoe.2020.04.013.', 'journal-title': 'Pulmonology'}, { 'issue': '5', 'key': '6104_CR25', 'first-page': '431', 'volume': '43', 'author': 'SX Zhang', 'year': '2020', 'unstructured': 'Zhang SX, Li J, Zhou P, et al. The analysis of clinical characteristics ' 'of 34 novel coronovirus pneumonia cases in Ningxia Huiautonomous region. ' 'ZhonghuaLie He He Hu XizaZhi. 2020;43(5):431–6.', 'journal-title': 'ZhonghuaLie He He Hu XizaZhi'}, { 'issue': '7', 'key': '6104_CR26', 'doi-asserted-by': 'publisher', 'first-page': '1021', 'DOI': '10.1515/cclm-2020-0369', 'volume': '58', 'author': 'BM Henry', 'year': '2020', 'unstructured': 'Henry BM, de Oliveira MHS, Benoit S, Plebani M, Lippi G. Hematologic, ' 'biochemical and immune biomarker abnormalities associated with severe ' 'illness and mortality in coronavirus disease 2019 (COVID-19): a ' 'meta-analysis. Clin Chem Lab Med. 2020;58(7):1021–8. ' 'https://doi.org/10.1515/cclm-2020-0369.', 'journal-title': 'Clin Chem Lab Med'}, { 'issue': '5', 'key': '6104_CR27', 'first-page': '554', 'volume': '32', 'author': 'M Fei', 'year': '2020', 'unstructured': 'Fei M, Tong F, Tao X, Wang J. Value of neutrophil-to-lymphocyte ratio in ' 'the classification diagnosis of coronavirus disease 2019. Zhonghua Wei ' 'Zhong Bing Ji Jiu Xue. 2020;32(5):554–8.', 'journal-title': 'Zhonghua Wei Zhong Bing Ji Jiu Xue'}, { 'issue': '1', 'key': '6104_CR28', 'doi-asserted-by': 'publisher', 'first-page': '206', 'DOI': '10.1186/s12967-020-02374-0', 'volume': '18', 'author': 'J Liu', 'year': '2020', 'unstructured': 'Liu J, Liu Y, Xiang P, Pu L, Xiong H, Li C, et al. Neutrophil to ' 'lymphocyte ratio predicts critical illnes patients with 2019 coronavirus ' 'disease in the early stage. J Transl Med. 2020;18(1):206. ' 'https://doi.org/10.1186/s12967-020-02374-0.', 'journal-title': 'J Transl Med'}, { 'issue': '1', 'key': '6104_CR29', 'doi-asserted-by': 'publisher', 'first-page': '169', 'DOI': '10.1186/s12931-020-01428-7', 'volume': '21', 'author': 'Y Wenjing', 'year': '2020', 'unstructured': 'Wenjing Y, Chen G, Li X, et al. Dynamic changes of D-dimer and ' 'neutrophil-lymphocyte countr atio as prognostic biomarkers in COVID-19. ' 'Respir Res. 2020;21(1):169.', 'journal-title': 'Respir Res'}, { 'issue': '9', 'key': '6104_CR30', 'doi-asserted-by': 'publisher', 'first-page': '1419', 'DOI': '10.1002/jmv.25843', 'volume': '92', 'author': 'AK Mishra', 'year': '2020', 'unstructured': 'Mishra AK, Sahu KK, Lal A. Reporting of all cardiac medications and ' 'their outcome in COVID-19. J Med Virol. 2020;92(9):1419–20. ' 'https://doi.org/10.1002/jmv.25843.', 'journal-title': 'J Med Virol'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-021-06104-9.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s12879-021-06104-9/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-021-06104-9.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 5, 5]], 'date-time': '2021-05-05T00:03:08Z', 'timestamp': 1620172988000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06104-9'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 5, 4]]}, 'references-count': 30, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['6104'], 'URL': 'http://dx.doi.org/10.1186/s12879-021-06104-9', 'relation': { 'has-preprint': [ { 'id-type': 'doi', 'id': '10.21203/rs.3.rs-224203/v1', 'asserted-by': 'object'}]}, 'ISSN': ['1471-2334'], 'subject': ['Infectious Diseases'], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2021, 5, 4]]}, 'assertion': [ { 'value': '8 February 2021', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '15 April 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '4 May 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'Ethics board approval (Afyonkarahisar Health Science University, Local Ethical ' 'Commitee 03.04.2020/139). All participants provided informed consent prior to ' 'study enrollment.', '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 neither financial nor non-financial ' 'competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '411'}
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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