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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality -33% Improvement Relative Risk Ventilation -33% Hospitalization 33% primary Viral clearance -5% Viral clearance (b) -27% Ivermectin  Vallejos et al.  EARLY TREATMENT  DB RCT Is early treatment with ivermectin beneficial for COVID-19? Double-blind RCT 501 patients in Argentina (August 2020 - February 2021) Lower hospitalization with ivermectin (not stat. sig., p=0.23) c19ivm.org Vallejos et al., BMC Infectious Diseases, Jul 2021 Favors ivermectin Favors control

Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial

Vallejos et al., BMC Infectious Diseases, doi:10.1186/s12879-021-06348-5
Jul 2021  
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Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020
 
*, now known with p < 0.00000000001 from 103 studies, recognized in 22 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments. c19ivm.org
RCT with 501 relatively low-risk outpatients in Argentina showing hospitalization OR 0.65 [0.32-1.31]. With only 7% hospitalization, this trial is underpowered. The trial primarily includes low-risk patients that recover quickly without treatment, leaving minimal room for improvement with treatment. 74 patients had symptoms for >= 7 days. Among the 7 patients requiring ventilation, authors note that the earlier requirement in the ivermectin group may be due to those patients having higher severity at baseline. However, authors know the answer to this - it is unclear why it is not reported. There were more adverse events in the placebo group than the ivermectin group, suggesting a possible issue with dispensing or non-trial medication usage. 25+% of patients were hospitalized within 2/3 days for the placebo/treatment groups (Figure S2).
The companion prophylaxis study IVERCOR PREP has reported results in the press and an online presentation lanacion.com.ar, twitter.com, however these results have not yet been formally published. The prophylaxis study results are very positive and statistically significant, and would be expected to receive priority publication due to the predicted impact on the pandemic and confirmation of previous prophylaxis studies. The lack of formal publication suggests a negative publication bias that may be due to politicization in the authors' location.
Authors pre-specify multivariate analysis but do not present it, however multivariate analysis could significantly change the results. Consider for example if just a few extra patients in the ivermectin group were in severe condition based on baseline SpO2. The lower mean SpO2 in the ivermectin group, and the shorter time to ventilation, are consistent with this being the case. Additionally, there are 14% more male patients in the ivermectin group.
An extremely large percentage of patients (55%) were excluded based on ivermectin use in the last 7 days. However, ivermectin may retain efficacy much longer (for example antiparasitic activity may persist for months Canga). A significant number of patients may also misrepresent their prior and future usage — the population is clearly aware of ivermectin, and patients with progressing disease may be motivated to take it, knowing that they may be in the control group. Another report states that 12,000 patients were excluded for recent use of ivermectin scidev.net).
RCTs have a fundamental bias against finding an effect for interventions that are widely available — patients that believe they need treatment are more likely to decline participation and take the intervention Yeh, i.e., RCTs are more likely to enroll low-risk participants that do not need treatment to recover (this does not apply to the typical pharmaceutical trial of a new drug that is otherwise unavailable). This trial was run in a community where ivermectin was very widely known and used.
For other issues see trialsitenews.com.
There were no serious adverse events. NCT04529525 (history).
This is the 28th of 50 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000014.
This is the 58th of 103 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 1 sextillion).
risk of death, 33.5% higher, RR 1.33, p = 0.70, treatment 4 of 250 (1.6%), control 3 of 251 (1.2%), odds ratio converted to relative risk.
risk of mechanical ventilation, 33.5% higher, RR 1.33, p = 0.70, treatment 4 of 250 (1.6%), control 3 of 251 (1.2%), odds ratio converted to relative risk.
risk of hospitalization, 33.0% lower, RR 0.67, p = 0.23, treatment 14 of 250 (5.6%), control 21 of 251 (8.4%), NNT 36, odds ratio converted to relative risk, primary outcome.
risk of no viral clearance, 5.0% higher, RR 1.05, p = 0.55, treatment 137 of 250 (54.8%), control 131 of 251 (52.2%), inverted to make RR<1 favor treatment, odds ratio converted to relative risk, day 3.
risk of no viral clearance, 26.8% higher, RR 1.27, p = 0.29, treatment 38 of 250 (15.2%), control 30 of 251 (12.0%), inverted to make RR<1 favor treatment, odds ratio converted to relative risk, day 12.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Vallejos et al., 2 Jul 2021, Double Blind Randomized Controlled Trial, Argentina, peer-reviewed, 29 authors, study period 19 August, 2020 - 22 February, 2021, average treatment delay 4.0 days, dosage 12mg days 1-2, <80kg 12mg, 80-110kg 18mg, >110kg 24mg.
This PaperIvermectinAll
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial
Julio Vallejos, Rodrigo Zoni, María Bangher, Silvina Villamandos, Angelina Bobadilla, Fabian Plano, Claudia Campias, Evangelina Chaparro Campias, Maria Fernanda Medina, Fernando Achinelli, Hector Andres Guglielmone, Jorge Ojeda, Diego Farizano Salazar, Gerardo Andino, Pablo Kawerin, Silvana Dellamea, Antonia Cristina Aquino, Victor Flores, Carolina N Martemucci, Silvina Maria Martinez, Juan Emanuel Segovia, Paola Itati Reynoso, Noelia Carolina Sosa, Mariana Elizabeth Robledo, Joaquina Maria Guarrochena, Maria Mercedes Vernengo, Natalia Ruiz Diaz, Elba Meza, María Gabriela Aguirre
BMC Infectious Diseases, doi:10.1186/s12879-021-06348-5
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease patients. Objective: To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19. Design, setting and participants: A randomized, double-blind, placebo-controlled study was conducted in nonhospitalized individuals with COVID-19 in Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate. The trial randomized 501 patients between August 19th 2020 and February 22nd 2021. Intervention: Patients were randomized to ivermectin (N = 250) or placebo (N = 251) arms in a staggered dose, according to the patient's weight, for 2 days. Main outcomes and measures: The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome. We evaluated secondary outcomes in relationship to safety and other efficacy end points.
Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s12879-021-06348-5. Additional file 1. Authors' contributions Declarations Ethics approval and consent to participate study authorized by Health Sciences Research Bioethics Committee (HSRBC) of the National University of the Northeast (UNNE) Faculty of Medicine, Argentina (Resolution 21/20 on August 17th, 2020). The consent to participate in the trial was approved by HSRBC of the UNNE. The study was performance in accordance with the Declaration of Helsinki and all methods were performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all participants prior to the study. The study has been supervised by a Steering Committee and Safety Committee. Consent for publication Not Applicable. Competing interests The authors declare that they have no competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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{ 'DOI': '10.1186/s12879-021-06348-5', 'ISSN': ['1471-2334'], 'URL': 'http://dx.doi.org/10.1186/s12879-021-06348-5', 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has ' 'changed our lives. The scientific community has been investigating re-purposed treatments to ' 'prevent disease progression in coronavirus disease (COVID-19) patients.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Objective</jats:title>\n' ' <jats:p>To determine whether ivermectin treatment can prevent hospitalization ' 'in individuals with early COVID-19.</jats:p>\n' ' <jats:p>Design, setting and participants: A randomized, double-blind, ' 'placebo-controlled study was conducted in non-hospitalized individuals with COVID-19 in ' 'Corrientes, Argentina. Patients with SARS-CoV-2 positive nasal swabs were contacted within ' '48\u2009h by telephone to invite them to participate. The trial randomized 501 patients ' 'between August 19th 2020 and February 22nd 2021.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Intervention</jats:title>\n' ' <jats:p>Patients were randomized to ivermectin ' '(<jats:italic>N</jats:italic>\xa0=\u2009250) or placebo (<jats:italic>N</jats:italic>\xa0' '=\u2009251) arms in a staggered dose, according to the patient’s weight, for 2\u2009' 'days.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Main outcomes and measures</jats:title>\n' ' <jats:p>The efficacy of ivermectin to prevent hospitalizations was evaluated ' 'as primary outcome. We evaluated secondary outcomes in relationship to safety and other ' 'efficacy end points.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>The mean age was 42\u2009years (SD\u2009±\u200915.5) and the median ' 'time since symptom onset to the inclusion was 4\u2009days [interquartile range 3–6]. The ' 'primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group ' 'and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32–1.31; ' '<jats:italic>p</jats:italic>\xa0=\u20090.227). Time to hospitalization was not statistically ' 'different between groups. The mean time from study enrollment to invasive mechanical ' 'ventilatory support (MVS) was 5.25\u2009days (SD\u2009±\u20091.71) in ivermectin group and ' '10\u2009days (SD\u2009±\u20092) in placebo group, (<jats:italic>p</jats:italic>\xa0=\u2009' '0.019). There were no statistically significant differences in the other secondary outcomes ' 'including polymerase chain reaction test negativity and safety outcomes.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Limitations</jats:title>\n' ' <jats:p>Low percentage of hospitalization events, dose of ivermectin and not ' 'including only high-risk population.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusion</jats:title>\n' ' <jats:p>Ivermectin had no significant effect on preventing hospitalization of ' 'patients with COVID-19. Patients who received ivermectin required invasive MVS earlier in ' 'their treatment. No significant differences were observed in any of the other secondary ' 'outcomes.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Trial registration</jats:title>\n' ' <jats:p>ClinicalTrials.gov <jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" ' 'xlink:href="https://clinicaltrials.gov/ct2/show/NCT04529525">NCT04529525</jats:ext-link>.</jats:p>\n' ' </jats:sec>', 'alternative-id': ['6348'], 'article-number': '635', 'assertion': [ { 'group': {'label': 'Article History', 'name': 'ArticleHistory'}, 'label': 'Received', 'name': 'received', 'order': 1, 'value': '6 May 2021'}, { 'group': {'label': 'Article History', 'name': 'ArticleHistory'}, 'label': 'Accepted', 'name': 'accepted', 'order': 2, 'value': '17 June 2021'}, { 'group': {'label': 'Article History', 'name': 'ArticleHistory'}, 'label': 'First Online', 'name': 'first_online', 'order': 3, 'value': '2 July 2021'}, {'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 authorized by the Health Sciences Research Bioethics Committee ' '(HSRBC) of the National University of the Northeast (UNNE) Faculty of Medicine, ' 'Argentina (Resolution 21/20 on August 17th, 2020). The consent to participate ' 'in the trial was approved by HSRBC of the UNNE. The study was performance in ' 'accordance with the Declaration of Helsinki and all methods were performed in ' 'accordance with the relevant guidelines and regulations. Informed consent was ' 'obtained from all participants prior to the study. 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' '2012;443(3):851–6. https://doi.org/10.1042/BJ20120150.', 'volume': '443', 'year': '2012'}, { 'DOI': '10.1016/j.antiviral.2020.104787', 'author': 'L Caly', 'doi-asserted-by': 'publisher', 'first-page': '104787', 'journal-title': 'Antivir Res', 'key': '6348_CR16', 'unstructured': 'Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ' 'Ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antivir Res. ' '2020;178:104787. https://doi.org/10.1016/j.antiviral.2020.104787.', 'volume': '178', 'year': '2020'}, { 'key': '6348_CR17', 'unstructured': 'Ministerio de Salud, Republica del Peru. Resolucion ministerial No. ' '270–2020-MINSA. Accessed March 8, 2021. ' 'https://cdn.www.gob.pe/uploads/document/file/694719/RM_270-2020-MINSA.PDF'}, { 'key': '6348_CR18', 'unstructured': 'Rodriguez Mega E. Latin America’s embrace of an unproven COVID treatment ' 'is hindering drug trials. Nature. Accessed March 8, 2021. 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' 'https://doi.org/10.1016/j.ijid.2020.11.191.', 'volume': '103', 'year': '2021'}, { 'DOI': '10.1016/j.eclinm.2020.100720', 'author': 'C Chaccour', 'doi-asserted-by': 'publisher', 'first-page': '100720', 'journal-title': 'EClinicalMedicine.', 'key': '6348_CR32', 'unstructured': 'Chaccour C, Casellas A, Blanco-Di Matteo A, et al. The effect of early ' 'treatment with ivermectin on viral load, symptoms and humoral response ' 'in patients with non-severe COVID-19: a pilot, double-blind, ' 'placebo-controlled, randomized clinical trial. EClinicalMedicine. ' '2021;32:100720. https://doi.org/10.1016/j.eclinm.2020.100720.', 'volume': '32', 'year': '2021'}, { 'DOI': '10.1371/journal.pone.0242184', 'author': 'D Camprubí', 'doi-asserted-by': 'publisher', 'first-page': 'e0242184', 'issue': '11', 'journal-title': 'PLoS One', 'key': '6348_CR33', 'unstructured': 'Camprubí D, Almuedo-Riera A, Martí-Soler H, et al. Lack of efficacy of ' 'standard doses of ivermectin in severe COVID-19 patients. 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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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