Filling the Gap Until Full Vaccine Deployment in the War on Coronavirus Disease-19

Mattoli, Sabrina

doi:10.1007/s40121-020-00394-3

Cited by 5 publications

(6 citation statements)

References 28 publications

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“…In late 2020, the authorization of SARS-CoV-2 emergency vaccines led to partial pandemic control. However, further studies will be key to obtain clear evidence on its treatment and prevention [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Effect of Vitamin D3 Supplementation vs. Dietary–Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL

Romero-Ibarguengoitia

Gutierrez-González

Cantú-López

et al. 2023

Microorganisms

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Background: There is scant information on the effect of supplementation with vitamin D3 in SARS-CoV-2 infection cases when patient 25-hydroxyvitamin D3 [25(OH)D3] levels are between 20–100 ng/mL. We aimed to evaluate the effect of supplementation with vitamin D3 vs. dietary–hygienic measures on the SARS-CoV-2 infection rate in participants with serum 25(OH)D3 levels ≥20 ng/mL. Methods: This study was quasi-experimental. We invited hospital workers with 25(OH)D3 levels between 20–100 ng/mL and no previous SARS-CoV-2 infection. They were randomized as follows: treatment options were a) vitamin D3 supplementation (52,000 IU monthly, G1) or b) dietary–hygienic measures (G2). We conducted a 3- to 6-month follow-up of SARS-CoV-2 infections. Participants with 25(OH)D3 levels <20 ng/mL were also analyzed. We divided these latter participants depending on whether they were supplemented (G3) or not (G4). Results: We analyzed 198 participants, with an average age of 44.4 (SD 9) years, and 130 (65.7%) were women. G1 had fewer cases of SARS-CoV-2 infection than G2 after a follow-up of 3- to 6-months (p < 0.05). There were no differences between G3 and G4 at the 3- and 6-month follow-up cutoff points (p > 0.05). Using a mixed effect Cox regression analysis in the 164 participants that completed six months of follow-up, vitamin D3 supplementation appeared to act as a protective factor against SARS-CoV-2 infection (HR 0.21, p = 0.008) in G1 and G2. None of the participants treated with the supplementation doses had serum 25(OH)D3 levels >100 ng/mL. Conclusions: Vitamin D3 supplementation in participants with 25(OH)D3 levels between 20–100 ng/mL have a lower rate of SARS-CoV-2 infection compared with the use of dietary–hygienic measures at six months follow-up.

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Section: Introductionmentioning

confidence: 99%

Effect of Vitamin D3 Supplementation vs. Dietary–Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL

Romero-Ibarguengoitia

Gutierrez-González

Cantú-López

et al. 2023

Microorganisms

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“…At the time of this writing (22 September 2022) the illness caused by SARS-CoV-2 and termed coronavirus disease 2019 (COVID-19) has already killed more than 6.5 million individuals and the pandemic is not over yet [6]. The devastating impacts on healthcare systems, economies, and education and social relationships have resulted in a global crisis with no precedent since the Second World War [7][8][9]. Highly efficacious vaccines have been developed in less than 1 year from SARS-CoV-2 identification [10] and the speed at which many countries have rolled out the vaccination program is unparalleled [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Investigational Use of Mesenchymal Stem/Stromal Cells and Their Secretome as Add-On Therapy in Severe Respiratory Virus Infections: Challenges and Perspectives

Mattoli¹,

Schmidt

2023

Adv Ther

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Serious manifestations of respiratory virus infections such as influenza and coronavirus disease 2019 (COVID-19) are associated with a dysregulated immune response and systemic inflammation. Treating the immunological/inflammatory dysfunction with glucocorticoids, Janus kinase inhibitors, and monoclonal antibodies against the interleukin-6 receptor has significantly reduced the risk of respiratory failure and death in hospitalized patients with severe COVID-19, but the proportion of those requiring invasive mechanical ventilation (IMV) and dying because of respiratory failure remains elevated. Treatment of severe influenza-associated pneumonia and acute respiratory distress syndrome (ARDS) with available immunomodulators and anti-inflammatory compounds is still not recommended. New therapies are therefore needed to reduce the use of IMV and the risk of death in hospitalized patients with rapidly increasing oxygen demand and systemic inflammation who do not respond to the current standard of care. This paper provides a critical assessment of the published clinical trials that have tested the investigational use of intravenously administered allogeneic mesenchymal stem/stromal cells (MSCs) and MSC-derived secretome with putative immunomodulatory/antiinflammatory/regenerative properties as add-on therapy to improve the outcome of these patients. Increased survival rates are reported in 5 of 12 placebo-controlled or open-label comparative trials involving patients with severe and critical COVID-19 and in the only study concerning patients with influenza-associated ARDS. Results are encouraging but inconclusive for the following reasons: small number of patients tested in each trial; differences in concomitant treatments and respiratory support; imbalances between study arms; differences in MSC source, MSC-derived product, dosing and starting time of the investigational therapy; insufficient/inappropriate reporting of clinical data. Solutions are proposed for improving the clinical development plan, with the aim of facilitating regulatory approval of the MSC-based investigational therapy for life-threatening respiratory virus infections in the future. Major issues are the absence of a biomarker predicting responsiveness to MSCs and MSC-derived secretome and the lack of pharmacoeconomic evaluations.

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Section: Introductionmentioning

confidence: 99%

“…However, further studies will be key to obtain clear evidence on its treatment and prevention 6 [6].…”

Section: Introductionmentioning

confidence: 99%

Effect of Vitamin D₃ supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital workers with 25-hydroxyvitamin D3 [25(OH)D3] levels ≥20 ng/mL

Romero-Ibarguengoitia

Gutierrez-González

Cantú-López

et al. 2022

Preprint

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Background. There is scant information on the effect of supplementation with vitamin D3 in SARS-COV-2 infection cases when patient 25-hydroxyvitamin D3 [25(OH)D3] levels are between 20-100ng/mL. Our aim was to evaluate the effect of supplementation with vitamin D3 vs. dietary-hygienic measures on the SARS-COV-2 infection rate in participants with serum 25(OH)D3 levels >20ng/mL. Methods. We invited hospital workers with 25(OH)D3 levels between 20-100 ng/mL and no previous SARS-COV-2 infection; they were randomized as follows: treatment options were a) vitamin D3 supplementation (52,000 IU monthly, G1) or b) dietary-hygienic measures (G2). We conducted a 3- to 6-month follow-up of SARS-COV-2 infections. Participants with 25(OH)D3 levels <20 ng/mL were also analyzed. We divided these latter participants depending on whether they were supplemented (G3) or not (G4). Results. We analyzed 198 participants, with an average age of 44.4 (SD 9) years, and 130 (65.7%) were women. G1 had less cases of SARS-COV-2 infection than G2 after a follow-up of 3- to 6-months (p<0.05). There were no differences between G3 and G4 at the 3- and 6-month follow-up cutoff points (p>0.05). Using mixed effect Cox regression analysis in 164 participants that completed six months of follow-up, vitamin D3 supplementation appeared to act as a protective factor against SARS-COV-2 infection (HR 0.21, p=0.008) in G1 and G2. None of the participants treated with the supplementation doses had serum 25(OH)D3 levels > 100ng/mL. Conclusion. Vitamin D3 supplementation in participants with 25(OH)D3 levels between 20-100 ng/mL have a lower rate of SARS-COV-2 infection in comparison with the use of dietary-hygienic measures at six months follow-up.

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Filling the Gap Until Full Vaccine Deployment in the War on Coronavirus Disease-19

Cited by 5 publications

References 28 publications

Effect of Vitamin D3 Supplementation vs. Dietary–Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL

Effect of Vitamin D3 Supplementation vs. Dietary–Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL

Investigational Use of Mesenchymal Stem/Stromal Cells and Their Secretome as Add-On Therapy in Severe Respiratory Virus Infections: Challenges and Perspectives

Effect of Vitamin D₃ supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital workers with 25-hydroxyvitamin D3 [25(OH)D3] levels ≥20 ng/mL

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Filling the Gap Until Full Vaccine Deployment in the War on Coronavirus Disease-19

Cited by 5 publications

References 28 publications

Effect of Vitamin D3 Supplementation vs. Dietary–Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL

Effect of Vitamin D3 Supplementation vs. Dietary–Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL

Investigational Use of Mesenchymal Stem/Stromal Cells and Their Secretome as Add-On Therapy in Severe Respiratory Virus Infections: Challenges and Perspectives

Effect of Vitamin D3 supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital workers with 25-hydroxyvitamin D3 [25(OH)D3] levels ≥20 ng/mL

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Resources

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Effect of Vitamin D₃ supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital workers with 25-hydroxyvitamin D3 [25(OH)D3] levels ≥20 ng/mL