Zinc Supplementation Impact in Acute COVID-19 Clinical Outcomes

NCT05778383 | Completed Phase 4

• 1 other identifier: 2021/9673/I
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Zinc Deficiency; Sars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to clinical stability

  day 14

• hospital length of stay

  day 14 and day 28

• Adverse Effects

  Day 14 and Day 28

Study Arms (2)

Standars of Care

NO INTERVENTION

Standard of Care of treatment for SARS-coV-2 infection

Zinc Supplementation +Standard of Care

EXPERIMENTAL

Standard of care + ( 240mg zinc acetate Zinc (75mg Zn element) +NM QD) during 14 days

Dietary Supplement: Zinc Acetate

Interventions

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

Zinc Supplementation +Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SARS-CoV-2 infection requiring hospital admission.

You may not qualify if:

• Previous immunization against SARS-CoV-2
• \<18 years
• pregnancy/breastfeeding
• oral intolerance
• life expectancy \<72h on admission.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Universitat Pompeu Fabra: collaborator

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (2)

• 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.

  PMID: 33572045 BACKGROUND

• Gomez-Zorrilla S, Sendra E, Du J, Espona M, Fierro-Villegas A, Siverio A, Rodriguez-Alarcon A, Castaneda S, Lopez Montesinos I, Plata C, Arrieta-Aldea I, Soldado-Folgado J, Garcia-Giralt N, Vicente R, Guerri-Fernandez R. Zinc adjuvant treatment in SARS-CoV-2: A randomized clinical trial. J Trace Elem Med Biol. 2025 Dec;92:127778. doi: 10.1016/j.jtemb.2025.127778. Epub 2025 Oct 10.

  PMID: 41076985 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Zinc Acetate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Robert Güerri-Fernández, M.D. Ph.D.

  PsMar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We are administering Zinc supplementation in the acute phase of SARS-CoV-2 infection

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 21, 2023
• Study Start: May 1, 2021
• Primary Completion: February 23, 2022
• Study Completion: May 25, 2022
• Last Updated: March 21, 2023

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)