Safety and Efficacy of the combined use of ivermectin, dexamethasone, enoxaparin and aspirin against COVID 19

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Abstract

From the first outbreak in Wuhan (China) in December 2019, until today the number of deaths worldwide due to the coronavirus pandemic exceeds eight hundred thousand people and the number of infected people arises to more than 25 million.

No treatment tested worldwide has shown unquestionable efficacy in the fight against COVID 19, according to NICE reports.

We have designed an experimental treatment called IDEA based on four affordable drugs already available on the market in Argentina, based on the following rationale:

  • - I vermectin solution at a relatively high dose to lower the viral load in all stages of COVID 19

  • - D examethasone 4-mg injection, as anti-inflammatory drug to treat hyperinflammatory reaction to COVID-infection

  • - E noxaparin injection as anticoagulant to treat hypercoagulation in severe cases.

  • - A spirin 250-mg tablets to prevent hypercoagulation in mild and moderate cases

  • Except for Ivermection oral solution, which was used in a higher dose than approved for parasitosis, all other drugs were used in the already approved dose and indication. Regarding Ivermectin safety, several oral studies have shown it to be safe even when used at daily doses much higher than those approved already.

    A clinical study has been conducted on COVID-19 patients at Eurnekian Hospital in the Province of Buenos Aires, Argentina. The study protocol and its final outcomes are described in this article. Results were compared with published data and data from patients admitted to the hospital receiving other treatments.

    None of the patient presenting mild symptoms needed to be hospitalized. Only one patient died (0.59 % of all included patients vs. 2.1 % overall mortality for the disease in Argentina today; 3.1 % of hospitalized patients vs. 26.8 % mortality in published data). IDEA protocol appears to be a useful alternative to prevent disease progression of COVID-19 when applied to mild cases and to decrease mortality in patients at all stages of the disease with a favorable risk-benefit ratio.

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    1. SciScore for 10.1101/2020.09.10.20191619: (What is this?)

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

      Table 1: Rigor

      Institutional Review Board StatementConsent: Patients: Patients included in this study protocol were male and female persons not less than 5 years old, with a positive rt-PCR diagnosis of COVID-19 performed on nasal swab specimens, able to provide informed consent and not participating in any other clinical study.
      IRB: Ethics Committee aproval: The study was approved both by the ethics committee of the hospital and the County Ethics Committee, in accordance with the Declaration of Helsinski and its ammendments.
      Randomizationnot detected.
      Blindingnot detected.
      Power Analysisnot detected.
      Sex as a biological variablePatients: Patients included in this study protocol were male and female persons not less than 5 years old, with a positive rt-PCR diagnosis of COVID-19 performed on nasal swab specimens, able to provide informed consent and not participating in any other clinical study.

      Table 2: Resources

      No key resources detected.


      Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


      Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

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

      IdentifierStatusTitle
      NCT04425863CompletedIvermectin, Aspirin, Dexamethasone and Enoxaparin as Treatme…


      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.