Evolution of COVID-19 patients treated with a combination of nutraceuticals to reduce symptomatology and improve prognosis: a multi-centred, retrospective cohort study

  1. Mariana Hernandez
  2. Jully Urrea
  3. Luciano Bascoy

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Abstract

Although a vast knowledge has already been gathered on the pathophysiology of COVID-19, there are still limited, non-optimal treatment options. In this paper, we describe a multicentre, retrospective, observational study to describe the course of SARS-CoV-2 disease in patients treated with ImmunoFormulation (IF), an add-on therapy developed to decrease duration of clinical symptoms. In parallel, a group of patients that did not receive IF was used for comparison (using standard of care treatment). A total of 39 patients were evaluated. Throughout the observational period, 90% of patients recovered in the IF cohort and 47.4% in the Control cohort (p=0.0057). From the symptoms with statistically significant differences, the duration of symptoms (i.e., the time to recover from it) was shorter in the IF cohort than in control cohort (in days, average), especially for fever (2.25 x 21.78), dry cough (4.38 x 24.00), dyspnoea (3.67 x 20.00), headache (2.00 x 26.50), diarrhoea (5.25 x 25.25), and weakness (1.92 x 23.30). This demonstrates a potential promising role of IF as adjuvant therapy on the evolution of symptomatology to COVID-19 patients.

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  1. ScreenIT

    SciScore for 10.1101/2020.12.11.20246561: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical approval for was granted by the Medicinal Product Research Ethics Committee of Hospital de Mar.
    Consent: All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The calculations were performed with the help of the PASS package, version 2011.
    PASS
    suggested: (PASS, RRID:SCR_005490)

    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: We detected the following sentences addressing limitations in the study:
    As a limitation of our study, we can point out the differences in age of the cohorts. Therefore, we can understand the data as a description of the fast times needed to recover from the most common COVID-19 symptoms, rather than a direct comparison between the cohorts.

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

    IdentifierStatusTitle
    NCT04666753CompletedRetrospective Study of ImmunoFormulation for COVID-19

    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.

  2. Version published to 10.1101/2020.12.11.20246561v1 on medRxiv