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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'abstract': '<jats:p>Objective: to evaluate the therapeutic intervention with Ivermectin in outpatients '
'with COVID-19 mild disease, to increase medical discharge and prevent the progression to '
'moderate or severe disease. Methods: Randomized Trial, n= 254. The subjects were divided into '
'experimental (EG: n= 110) and control groups (CG: n= 144). The EG received Ivermectin orally '
'0.6 mg/kg weight in two doses. 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<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>',
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