Rossana Elena Chahla, Luis Medina Ruiz, Teresa Mena, Yolanda Brepe, Paola Terranova, Eugenia Silvana Ortega, Guillermo Gabriel Barrenechea, View ORCID ProfileDaniel Gustavo Goroso, Maria de los Angeles Peral de Bruno
doi: https://doi.org/10.1101/2021.03.29.21254554
Abstract
Background The emergence of COVID-19 requires alternative treatments based on the reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS-COV-2. The goal was to evaluate the use of ivermectin in mild stage outpatients to heal and / or reverse the progression of COVID-19 disease towards the development of moderate or severe stages.
Methods Cluster Assigned Clinical Trial (2:1) in outpatients, n = 234. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 62). The EG received ivermectin orally 4 drops of 6 mg = 24 mg every 7 days for 4 weeks. All participants were diagnosed by positive RT-PCR for COVID-19 and were evaluated by clinical examination, at the beginning and the end of protocol. Data analyzed were applied the proportion, bivariate, and logical regression tests with level significance p < 0·05. This study was registered at ClinicalTrials.gov Identifier NCT04784481. Findings Both groups were similar in age, sex, and comorbidities (EG: 56F, median age= 40·0, range: 18·0 - 75·0; CG: 34F, median age = 37·5, range: 18·0 - 71·0). A significant reduction in the symptom numbers was observed in the EG when the medical examination was performed from 5th to 9th days, after starting treatment (p = 0·0026). Although, medical examination from 10th to 14th day, showed a progressive reduction of the percentage symptom numbers, these were not significative in both groups. A higher proportion of medical release was observed in EG (98·2%) vs CG (87·1%) (p = 0·003). EG showed 8 times more chance of receiving medical release than CG (OR 7·99, 95% CI: 1·64 −38·97, p = 0·003). The treatment effect with ivermectin to obtain medical release was analyzed by the logistic regression model based in the following control variables: sex, age, and comorbidities. Then, the chance to obtain medical release was maintained in EG (OR 10·37, 95% CI: 2·05 - 52·04, p = 0·005). Interpretation Treatment with ivermectin in outpatients with mild stage COVID-19 disease managed to slightly reduce the symptom numbers. Also, this treatment improved the clinical state to obtain medical release, even in the presence of comorbidities. The treatment with ivermectin could significantly prevent the evolution to serious stages since the EG did not present any patient with referral to critical hospitalization.[/fusion_text][fusion_text columns="" column_min_width="" column_spacing="" rule_style="" rule_size="" rule_color="" hue="" saturation="" lightness="" alpha="" content_alignment_medium="" content_alignment_small="" content_alignment="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" sticky_display="normal,sticky" class="" id="" margin_top="" margin_right="" margin_bottom="" margin_left="" fusion_font_family_text_font="" fusion_font_variant_text_font="" font_size="" line_height="" letter_spacing="" text_transform="" text_color="" animation_type="" animation_direction="left" animation_color="" animation_speed="0.3" animation_delay="0" animation_offset=""]
Keywords: ivermectin
