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Completed

NCT Number: NCT05778383

Zinc Supplementation Impact in Acute COVID-19 Clinical Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

Background: The essential micronutrient zinc balances immune responses to infections and additionally directly inhibits some viruses. The investigators have recently shown a robust correlation between serum zinc levels (SZL)and COVID-19 outcome in patients and a direct effect of zinc levels on SARS-CoV-2 expansion in cell culture.These results suggest that SZL might represent an important risk factor for COVID-19 severity whose adjustment would constitute an early and cost-effective therapeutic intervention.

Objectives: To explore the therapeutic benefit of zinc supplementation for COVID-19 patients and to determine the cellular and molecular basis of the effect of zinc levels on SARS-CoV-2 infections.

Methodology: A randomized clinical trial supplementing COVID-19 patients with zinc will be carried out and viral loads, inflammatory and novel zinc-related clinical markers and SARS-CoV-2-specific T- and B-cell Responses monitored. Humanized-ACE2-mice models will be used to address causal-effect associations between zinc levels and SARS-CoV-2 infection. Infections of human Calu-3 cells will be used to decipher the direct antiviral action of zinc on SARS-CoV-2 life cycle. Expected results: The investigators will generate a clear insight into zinc functioning in COVID-19 patients that might provide a therapeutic guideline immediately applicable to reduce the severity of SARS-CoV-2 pathogenicity and possibly other virus infections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc acetate

Dietary Supplement

Each participant allocated in the intervention arm will be treated as Standard of Care and will be supplemented with 240mg of Zinc Acetate

Primary outcomes

  1. Risk of progression

    Time frame: day 14

    progression to severe forms of SARS-Cov-2 disease, assessed by a combined outcome that includes mortality and/or need for ICU admission

Secondary outcomes

  1. Time to clinical stability

    Time frame: day 14

    time until clinical stability (defined as basal saturation >94%, HR <100l/min, SBP>90mm Hg and afebrile)

  2. hospital length of stay

    Time frame: day 14 and day 28

    days of hospital stay

  3. Adverse Effects

    Time frame: Day 14 and Day 28

    Adverse Effects

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Universitat Pompeu Fabra

Registry information

Official study title

Zinc-based Nutritional Immunity to Lower Inflammation, Viral Load and COVID-19 Mortality During SARS-CoV-2 Infection.

Acronym: MARZINC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2023
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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