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. 2023 Jun 22:10:1137407.
doi: 10.3389/fnut.2023.1137407. eCollection 2023.

NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial

Jean Gérain  1 , Melanie Uebelhoer  2 , Bérénice Costes  2 , Julie Herman  2 , Sandra Pietri  2 , Anne-Françoise Donneau  3 , Justine Monseur  3 , Yves Henrotin  2
Affiliations

NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial

Jean Gérain et al. Front Nutr. .

Abstract

Objectives: The effect and safety of Nasafytol®, a food supplement combining curcumin, quercetin, and Vitamin D, on hospitalized COVID-19-positive patients as support to standard of care were to be assessed.

Methods: This exploratory, open-label, randomized, controlled trial was carried out among hospitalized adults with COVID-19 infection. Participants were randomly assigned to receive Nasafytol® or Fultium® control. The improvement of the clinical condition and occurrence of (serious) adverse events were evaluated. The study was registered on clincaltrials.gov with the identifier NCT04844658.

Results: Twenty-five patients received Nasafytol®, and 24 received Fultium®. Demographic characteristics were well balanced between the groups. On day 14 (or at hospital leave if < 14 days), no difference was observed between groups regarding their clinical condition, fever, or the need of oxygen therapy. At day 7, however, 19 participants had been discharged from the hospital in the Nasafytol® arm compared to 10 participants in the Fultium® arm. No participants were transferred to the ICU or died in the Nasafytol® arm, vs. 4 transfers and 1 death in the Fultium® arm. The clinical condition of participants in the Nasafytol® arm had improved, as evidenced by a decrease in the COVID-19 WHO score. Interestingly, five SAEs occurred with Fultium®, while no SAE was observed with Nasafytol®.

Conclusion: Supplementation with Nasafytol®, in addition to standard-of-care treatment, led to a faster discharge from the hospital, improved clinical conditions of participants, and a reduced risk of serious outcomes, including transfer to the intensive care unit or death, in patients hospitalized with COVID-19.

Keywords: COVID-19; SARS–CoV-2; clinical trial; coronavirus; curcumine; food supplement; quercetine; vitamin D.

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Conflict of interest statement

YH is the founder and president of Artialis SA, a spin-off company of the University of Liège. YH has also received consulting and speaker fees from Tilman SA, Nestlé, Laboratoire Expanscience, Heel, Megalab, Genequine, LABHRA, and Biose. MU, BC, JH, and SP are employees of Artialis SA. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Efficacy outcomes of Nasafytol® versus Fultium® at day 7: Boxplot of the COVID-19 WHO ordinal outcome score. Adjusted value of p: *p < 0.05.
Figure 3
Figure 3
Efficacy outcomes of Nasafytol® versus Fultium® at day 7. (A) Number of discharged participants. (B) Number of hospitalized participants. (C) Number of transfers to the ICU or deaths. Adjusted value of p: *p < 0.05.
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References

    1. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. . Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. (2020) 395:1054–62. doi: 10.1016/S0140-6736(20)30566-3, PMID: - DOI - PMC - PubMed
    1. Bayati M, Noroozi R, Ghanbari-Jahromi M, Jalali FS. Inequality in the distribution of Covid-19 vaccine: a systematic review. IJEqH. (2022) 21. Available from::122. doi: 10.1186/s12939-022-01729-x, PMID: - DOI - PMC - PubMed
    1. WHO Solidarity Trial Consortium. Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, et al. . Repurposed antiviral drugs for Covid-19—interim WHO solidarity trial results. N Engl J Med. (2021) 384:497–511. doi: 10.1056/NEJMoa2023184, PMID: - DOI - PMC - PubMed
    1. Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Poissy J, Belhadi D, et al. . Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Lancet Infect Dis. (2022) 22:209–21. doi: 10.1016/S1473-3099(21)00485-0, PMID: - DOI - PMC - PubMed
    1. Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. . Remdesivir for the treatment of Covid-19—final report. N Engl J Med. (2020) 383:1813–26. doi: 10.1056/NEJMoa2007764, PMID: - DOI - PMC - PubMed

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