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Research
María de los Ángeles Peral de Bruno
Ministry of Public Health Tucumán
Corresponding Author
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Background The emergency of COVID-19, along with the current difficulties in responding to the high demand for vaccines, requests to the scientific community to find alternative treatments based on reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS COV 2. This study aims to evaluate the use of ivermectin in mild-stage patients to increase outpatient discharge and prevent the progression to moderate or severe stages of the disease.
Methods Cluster Randomised Trials in outpatients care, n = 254. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 144). The EG received ivermectin orally 4 tablets 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 using proportion, bivariate and logistic regression. P-value was considered significant at the p < 0·05 threshold. This study was registered at ClinicalTrials.gov Identifier NCT04784481.
Findings Both groups were similar in age, sex, and comorbidities (EG: median age = 40·0, range: 18·0–75·0, 42·11% Female; CG: median age = 36, range: 18·0–71·0, 57·89% Female). 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 (p = 0·0005). When the clinical evaluation was performed from 10th to 14th day there was no significant difference. A higher proportion of outpatient discharge was observed in EG (98·2%) vs. CG (86·1%) (p-Value = 0·0007). EG showed 8 times more chance of receiving discharge than CG (8·71 CI = [1·99, 38·12]; p = 0·004). The treatment effect with ivermectin to obtain discharge from outpatient care was analyzed by the logistic regression. Then, the chance to obtain outpatient discharge was independent of variables sex, age, and comorbidities.
Interpretation Treatment with ivermectin in outpatients care with mild disease of COVID-19 managed to slightly reduce PPS. Also, this treatment improved the clinical state to obtain outpatient discharge, 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.
Keywords
COVID-19, Ivermectin, Outpatient care, Mild-stage, Health Primary Care.
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This is a preprint. It has not completed peer review.
Research
María de los Ángeles Peral de Bruno
Ministry of Public Health Tucumán
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 06 May, 2021
Community comments: 1
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background The emergency of COVID-19, along with the current difficulties in responding to the high demand for vaccines, requests to the scientific community to find alternative treatments based on reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS COV 2. This study aims to evaluate the use of ivermectin in mild-stage patients to increase outpatient discharge and prevent the progression to moderate or severe stages of the disease.
Methods Cluster Randomised Trials in outpatients care, n = 254. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 144). The EG received ivermectin orally 4 tablets 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 using proportion, bivariate and logistic regression. P-value was considered significant at the p < 0·05 threshold. This study was registered at ClinicalTrials.gov Identifier NCT04784481.
Findings Both groups were similar in age, sex, and comorbidities (EG: median age = 40·0, range: 18·0–75·0, 42·11% Female; CG: median age = 36, range: 18·0–71·0, 57·89% Female). 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 (p = 0·0005). When the clinical evaluation was performed from 10th to 14th day there was no significant difference. A higher proportion of outpatient discharge was observed in EG (98·2%) vs. CG (86·1%) (p-Value = 0·0007). EG showed 8 times more chance of receiving discharge than CG (8·71 CI = [1·99, 38·12]; p = 0·004). The treatment effect with ivermectin to obtain discharge from outpatient care was analyzed by the logistic regression. Then, the chance to obtain outpatient discharge was independent of variables sex, age, and comorbidities.
Interpretation Treatment with ivermectin in outpatients care with mild disease of COVID-19 managed to slightly reduce PPS. Also, this treatment improved the clinical state to obtain outpatient discharge, 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.
Figure 1
Figure 2
Figure 3
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