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Randomized trials - Ivermectin repurposing for COVID-19 treatment of outpatients with mild disease in primary health care centers

Chahla et al., Research, Society and Development, doi:10.33448/rsd-v11i8.30844 (date from preprint), NCT04784481
Mar 2021  
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Discharge 87% primary Improvement Relative Risk Ivermectin  Chahla et al.  EARLY TREATMENT  RCT Is early treatment with ivermectin beneficial for COVID-19? RCT 254 patients in Argentina (September 2020 - January 2021) Higher discharge with ivermectin (p=0.004) c19ivm.org Chahla et al., Research, Society and D.., Mar 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 105 studies, recognized in 23 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 110 treatments. c19ivm.org
Cluster RCT outpatients in Argentina showing significantly faster recovery with ivermectin. There were no deaths. Outpatients in Tucumán were assigned to the ivermectin group and outpatients from San Miguel de Tucumán and Gran San Miguel de Tucumán were assigned to the control group. All comorbidities, percentage of male patients, and age were higher in the ivermectin group, favoring the control group.
This is the 22nd of 52 COVID-19 RCTs for ivermectin, which collectively show efficacy with p=0.00000021.
This is the 46th of 105 COVID-19 controlled studies for ivermectin, which collectively show efficacy with p<0.0000000001 (1 in 774 quintillion).
risk of no discharge, 86.9% lower, RR 0.13, p = 0.004, treatment 2 of 110 (1.8%), control 20 of 144 (13.9%), NNT 8.3, adjusted per study, inverted to make RR<1 favor treatment, odds ratio converted to relative risk, logistic regression, multivariable, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chahla et al., 30 Mar 2021, Cluster Randomized Controlled Trial, Argentina, peer-reviewed, 9 authors, study period September 2020 - January 2021, dosage 24mg days 1, 8, 15, 22, trial NCT04784481 (history). Contact: rchahla@msptucuman.gov.ar, lmedinaruiz09@gmail.com, terevmena@gmail.com, yebrepe@gmail.com, paoterranova@hotmail.com, eugesortega@gmail.com, barrenecheagg@gmail.com, danielg@umc.br, mperal@fm.unt.edu.ar.
This PaperIvermectinAll
Randomized trials - Ivermectin repurposing for COVID-19 treatment of outpatients with mild disease in primary health care centers
Rossana Elena Chahla, Luis Medina Ruiz, Teresa Mena, Yolanda Brepe, Paola Terranova, Eugenia Silvana Ortega, Guillermo Gabriel Barrenechea, Daniel Gustavo Goroso, María De Los Ángeles Peral De Bruno
Research, Society and Development, doi:10.33448/rsd-v11i8.30844
Randomized trials -Ivermectin repurposing for COVID-19 treatment of outpatients with mild disease in primary health care centers Ensaio aleatório -Reutilização de Ivermectina para tratamento COVID-19 de pacientes ambulatórios com doença leve em centros primários de saúde Ensayos aleatorios -Reutilización de la Ivermectina para el tratamiento con COVID-19 de pacientes ambulatorios con enfermedad leve en centros de atención primaria
Declarations Ethics approval and consent to participate The people who agreed to participate in the study gave their informed consent before starting the study. The protocol was approved by Independent Ethical Committee / Health Research Directorate, Ministry of Health, Tucumán Government, Argentina, IRB: 054/2020 in accordance with the ReNIS, National Register in Health Research, Argentina /0032. Consent for publication "Not applicable" Conflict of Interests The authors did not receive any monetary compensation for this work. They declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Authors' contributions ESO supervised the database. GGB, ESO and DGG contributed with the data processing and contributed to the statistical analysis. ESO, DGG and MPB were responsible for writing the manuscript. TM, YB and PT contributed to data collection. REC and LMR were the institutional managers to carry out the work. MPB supervised the project.
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All participants were by physical examination COVID-19 ' 'diagnosed with negative RT-PCR at the beginning and the end of protocol. Differences between ' 'the variables were determined using the Chi-square test (p&lt;0.05). The contagion risk (Odds ' 'Ratio) was calculated using software STATA. Results: Both groups were similar in age, sex, ' 'and comorbidities. A significant reduction in the percentage of participants with symptoms ' '(PPS) was observed in the EG and CG when the clinical evaluation of symptoms was performed ' 'from 5th to 9th day (p= 0.0005). When the clinical evaluation was performed from 10th to 14th ' 'day there was no significant difference. A higher proportion of medical discharge was ' 'observed in EG (98.2%) vs. CG (86.1%) (p= 0.0007). EG showed 8 times more chance of receiving ' 'medical discharge than CG (OR 8.71, 95% CI: 1·99 – 38.12, p= 0.004). The treatment effect ' 'with Ivermectin to obtain medical discharge from outpatient care was analyzed by logistic ' 'regression. Then, the chance to obtain medical discharge was independent of variables sex, ' 'age, and comorbidities. Conclusion: This work supports the potential efficacy of Ivermectin ' 'in outpatient care with mild COVID-19 as a potentially useful intervention of public health ' 'consideration.</jats:p>', 'DOI': '10.33448/rsd-v11i8.30844', 'type': 'journal-article', 'created': {'date-parts': [[2022, 6, 24]], 'date-time': '2022-06-24T11:54:03Z', 'timestamp': 1656071643000}, 'page': 'e35511830844', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Randomized trials - Ivermectin repurposing for COVID-19 treatment of outpatients with mild ' 'disease in primary health care centers', 'prefix': '10.33448', 'volume': '11', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-3016-612X', 'authenticated-orcid': False, 'given': 'Rossana Elena', 'family': 'Chahla', 'sequence': 'first', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-2014-1666', 'authenticated-orcid': False, 'given': 'Luis Medina', 'family': 'Ruiz', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-9838-5559', 'authenticated-orcid': False, 'given': 'Teresa', 'family': 'Mena', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-4071-4927', 'authenticated-orcid': False, 'given': 'Yolanda', 'family': 'Brepe', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-0370-3599', 'authenticated-orcid': False, 'given': 'Paola', 'family': 'Terranova', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-8339-1160', 'authenticated-orcid': False, 'given': 'Eugenia Silvana', 'family': 'Ortega', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-5781-8327', 'authenticated-orcid': False, 'given': 'Guillermo Gabriel', 'family': 'Barrenechea', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-5454-9873', 'authenticated-orcid': False, 'given': 'Daniel Gustavo', 'family': 'Goroso', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-0632-9427', 'authenticated-orcid': False, 'given': 'María de los Ángeles', 'family': 'Peral de Bruno', 'sequence': 'additional', 'affiliation': []}], 'member': '19099', 'published-online': {'date-parts': [[2022, 6, 21]]}, 'container-title': 'Research, Society and Development', 'original-title': [], 'link': [ { 'URL': 'https://rsdjournal.org/index.php/rsd/article/download/30844/26582', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://rsdjournal.org/index.php/rsd/article/download/30844/26582', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 6, 24]], 'date-time': '2022-06-24T11:54:03Z', 'timestamp': 1656071643000}, 'score': 1, 'resource': {'primary': {'URL': 'https://rsdjournal.org/index.php/rsd/article/view/30844'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 6, 21]]}, 'references-count': 0, 'journal-issue': {'issue': '8', 'published-online': {'date-parts': [[2022, 6, 6]]}}, 'URL': 'http://dx.doi.org/10.33448/rsd-v11i8.30844', 'relation': {}, 'ISSN': ['2525-3409'], 'container-title-short': 'RSD', 'published': {'date-parts': [[2022, 6, 21]]}}
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