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

  1. Rossana Elena Chahla
  2. Luis Medina Ruiz
  3. Teresa Mena
  4. Yolanda Brepe
  5. Paola Terranova
  6. Eugenia Silvana Ortega
  7. Guillermo Gabriel Barrenechea
  8. Daniel Gustavo Goroso
  9. María de los Ángeles Peral de Bruno

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Abstract

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.

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  1. Version published to 10.33448/rsd-v11i8.30844
  2. ScreenIT

    SciScore for 10.1101/2021.03.29.21254554: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: The people who agreed to participate in the study gave their informed consent before starting the study (Research Ethics Committee / Health Research Directorate, file number 054/2020).
    IRB: The people who agreed to participate in the study gave their informed consent before starting the study (Research Ethics Committee / Health Research Directorate, file number 054/2020).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Calculations were performed using STATA 11.2.
    STATA
    suggested: (Stata, RRID:SCR_012763)

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study has sizable limitations. The absence of a placebo group is due to the lack of funding from a sponsor and the need to guarantee treatment to the entire population. Other way, sample size, although representative, is small to obtain conclusive results. It’s a descriptive study of clinical follow up at 28 days. However, shows overlaps in benefits with other authors, and taking together, these results are encouraging for further study about repurposing ivermectin for the treatment of COVID-19, considering that is an inexpensive drug and is accessible in the local pharmaceutical industry (Argentina). We suggest new clinical intervention studies in our region and partners in other countries that may show the effect of the IVER compound in mild-stage outpatients.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04784481CompletedIvermectin Reproposing for Mild Stage COVID-19 Outpatients

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.03.29.21254554v1 on medRxiv