Dual Effects of Nanoviricides Platform Technology Based NV-CoV-2 Biomimetic Polymer Against COVID-19

  1. Anil Diwan
  2. Ashok Chakraborty
  3. Vijetha Chiniga
  4. Vinod Arora
  5. Preetam Holkar
  6. Yogesh Thakur
  7. Jay Tatake
  8. Randall Barton
  9. Neelam Holkar
  10. Bethany Pond

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Abstract

Remdesivir (RDV) is the only antiviral drug so far approved for COVID-19 therapy by the FDA. However its efficacy is limited in vivo due to its low stability in presence of plasma. This paper compared the stability of RDV encapsulated with our platform technology based polymer NV-387 (NV-CoV-2), in presence of plasma in vitro and in vivo . Furthermore, a non- clinical pharmacology studies of NV-CoV-2 (Polymer) and NV-CoV-2-R (Polymer encapsulated Remdesivir ) in both NL-63 infected and uninfected rats were done. In an in vitro cell culture model experiment, antiviral activity of NV-CoV-2 and NV-CoV-2-R are also compared with RDV.

The results are (i) NV-CoV-2 polymer encapsulation protects RDV from plasma- mediated catabolism in vitro and in vivo , too. (ii) Body weight measurements of the normal (uninfected) rats after administration of the test materials (NV-CoV-2, and NV-CoV-2-R) show no toxic effects on them. (iii) NL-63 infected rats body weights and their survival length were like uninfected rats after treatment with NV-CoV-2 and NV-CoV-2-R, and the efficacy as an antiviral regimen were found in the order as below: NV-CoV-2-R > NV-CoV-2 > RDV.

In brief, our platform technology based NV-387-encapsulated-RDV (NV-CoV-2-R) drug has a dual effect on coronaviruses. First, NV-CoV-2 itself as an antiviral regimen. Secondly, RDV is protected from plasma-mediated degradation in transit, rendering altogether the safest and an efficient regimen against COVID-19.

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  1. ScreenIT

    SciScore for 10.1101/2021.11.24.469813: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variableIn vivo antiviral activities of NV-CoV-2: Dose-response of NV-CoV-2 in rats infected with CoV-NL63: Male and female Sprague Dawley rats, 8 to 9 weeks old, were infected with 104 Cov- NL63 viral particles directly into the lungs.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The biotinylated detection antibody, 5G8-Biotin, used in this assay has been shown to be specific to NV-CoV-2.
    5G8-Biotin
    suggested: None
    The antigen (NV-CoV-2) is first immobilized onto each well of a 96-well assay plate and then incubated with diluted subject serum samples or positive control, normal serum spiked with rat Anti-NV-CoV-2 antibodies.
    antigen (NV-CoV-2
    suggested: None
    The bound Anti-NV- CoV-2 antibody is then detected by incubating with 1:1 mixture of HRP-conjugated Goat Anti- Rat IgG and IgM antibodies and quantitated with a chromogenic HRP substrate (TMB).
    Anti-NV- CoV-2
    suggested: None
    Anti-
    suggested: None
    IgM
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    In brief, LLC-MK2 cells (for CoV NL63 virus) and MRC-5 cells (for CoV 229E virus) were plated in 96-well black, clear bottom plates at a density of 30,000 cells per well in 100 μl media for 24hr prior to infection.
    LLC-MK2
    suggested: None
    MRC-5
    suggested: None
    Experimental Models: Organisms/Strains
    SentencesResources
    In vivo antiviral activities of NV-CoV-2: Dose-response of NV-CoV-2 in rats infected with CoV-NL63: Male and female Sprague Dawley rats, 8 to 9 weeks old, were infected with 104 Cov- NL63 viral particles directly into the lungs.
    Sprague Dawley
    suggested: None
    Effect of Number of Days of Dosing of NV-CoV-2 in Rats Infected with CoV-NL63: Male and female Sprague-Dawley rats, 8 to 9 weeks old, were infected with 2 x 104 Cov- NL63 viral particles directly into the lungs.
    Sprague-Dawley
    suggested: None
    Software and Algorithms
    SentencesResources
    The following parameters were analyzed using the Ponemah 5.20 SP9 and ECG Analysis Module v.
    Ponemah
    suggested: (Ponemah, RRID:SCR_017107)

    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: No clinical trial numbers were referenced.

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.11.24.469813v1 on bioRxiv