Sars-CoV-2 Infection Clinical Trial
— MARZINCOfficial title:
Zinc-based Nutritional Immunity to Lower Inflammation, Viral Load and COVID-19 Mortality During SARS-CoV-2 Infection.
Verified date | March 2021 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Infections with SARS-CoV-2 result in a systemic disease with a variety of outcomes, from no symptoms to severe and diverse pathologies. Therefore, it is important to identify risk factors determining COVID-19 severity, especially if those factors might be adjusted, allowing early and effective therapeutic interventions. Zinc is a trace element essential for human health. Zinc deficiency is common in old adults, vegetarians and patients with chronic inflammatory diseases. This condition causes immune dysfunction leading to increased risk of inflammatory and infectious diseases, including acquired immune deficiency syndrome, measles, malaria, tuberculosis, and pneumonia. Besides, zinc has a direct antiviral activity against specific viruses like rhinovirus, HCV, herpes simplex virus. In this scenario, it has been shown that zinc supplementation has benefits on the recurrence and persistence of acute and chronic viral infections like common cold or HCV, HBV. Moreover, our team has recently done an observational study with 249 COVID-19 patients that showed how COVID-19 patients with lower plasma zinc content had worse prognosis, increased time of hospitalization and mortality. Therefore, the main aim of the project is to explore the therapeutic benefit of zinc supplementation for COVID-19 patients and to determine the cellular and molecular basis of the effect of Zn levels on SARS CoV-2 infections. For that purpose the investigators will run a clinical trial supplementing with zinc COVID-19 patients. Moreover, the investigators will carry out experiments to understand the association between zinc nutritional status and SARS-Cov-2 infection progression in cellular and animal models. Given the current knowledge about zinc supplementation toxicity and dosage, the investigators expect that recommendations derived from this study will be rapidly applied by physicians and public health decision makers. The results of these studies will be used as a guideline to administer zinc supplements in COVID-19 patients in order to reduce disease severity and mortality. Moreover, the experiments will clarify whether zinc supplementation as a prophylaxis strategy is useful to protect the population at risk of zinc deficiency, more than 20% worldwide. Finally, considering the new knowledge that this project will generate about the role of zinc in immune responses and viral expansion, the investigators expect that our results will help researchers and physicians to design novel strategies to boost specific immune cell subpopulations against SARS-CoV2 infection. Thus, this knowledge could be used long-term for designing medicines against SARS-CoV-2 and other viral infections.
Status | Completed |
Enrollment | 75 |
Est. completion date | May 25, 2022 |
Est. primary completion date | February 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - SARS-CoV-2 infection requiring hospital admission. Exclusion Criteria: - Previous immunization against SARS-CoV-2 - <18 years - pregnancy/breastfeeding - oral intolerance - life expectancy <72h on admission. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar | Universitat Pompeu Fabra |
Spain,
Vogel-Gonzalez M, Tallo-Parra M, Herrera-Fernandez V, Perez-Vilaro G, Chillon M, Nogues X, Gomez-Zorrilla S, Lopez-Montesinos I, Arnau-Barres I, Sorli-Redo ML, Horcajada JP, Garcia-Giralt N, Pascual J, Diez J, Vicente R, Guerri-Fernandez R. Low Zinc Levels at Admission Associates with Poor Clinical Outcomes in SARS-CoV-2 Infection. Nutrients. 2021 Feb 9;13(2):562. doi: 10.3390/nu13020562. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk of progression | progression to severe forms of SARS-Cov-2 disease, assessed by a combined outcome that includes mortality and/or need for ICU admission | day 14 | |
Secondary | Time to clinical stability | time until clinical stability (defined as basal saturation >94%, HR <100l/min, SBP>90mm Hg and afebrile) | day 14 | |
Secondary | hospital length of stay | days of hospital stay | day 14 and day 28 | |
Secondary | Adverse Effects | Adverse Effects | Day 14 and Day 28 |
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