LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19

NCT05783180 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: SES-LFZN-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19. The main question is: Is there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete the following activities.

• Screening and first day of treatment
• Treatment that will be administered for up to 10 days, two treatment evaluation visits will be completed
• After treatment completion. Two visits are scheduled, one 28 days after the last dose and the other 60 days after the last dose. Researchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is Reduction in the signs and symptoms of COVID-19 at the end of treatment

Conditions

COVID-19

Keywords

Liposomal lactoferrin; liposomal Zinc; COVID-19

Outcome Measures

Primary Outcomes (1)

• Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).

  The scale used by Serrano et al., 2020 during the Phase 1 Sesderma LACTYFERRIN™ Forte trial quantified the presence of COVID-19 signs and symptoms, and their reduction during treatment time will be used in this phase with the same purpose

  11 days (one day after last study medication dose)

Secondary Outcomes (4)

• The proportion of patients with disease progression on Day 28

  up to 28 days after first study medication dose

• Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale

  5,11 and 28 days after first study medication dose

• The change in blood levels of inflammatory biomarkers

  5,11 and 28 days after first study medication dose

• Adverse event

  through study completion, an average of 70 days

Study Arms (2)

Treatment

EXPERIMENTAL

Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).

Drug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™

Control

PLACEBO COMPARATOR

Placebo +SOC (N=20)

Drug: Placebo

Interventions

Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ DRUG

Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD)

Treatment

Placebo DRUG

Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)

Control

Eligibility Criteria

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

You may qualify if:

• Patient or legally authorized representative must be willing to sign an informed consent.
• Male or female ≥18 years of age at the time of enrollment.
• COVID-19 diagnosis confirmed by SARS-CoV-2 detection by polymerase chain reaction (PCR) or other commercial or public health assays in any specimen documented by any of the following:
• PCR positive in samples collected ≤ 72h.
• PCR positive in samples collected \>72h and less than 7 days of disease progression.
• Mild to moderate symptoms of COVID-19 as determined by investigators following the criteria from NIH COVID 19 Treatment Guidelines for (APPENDIX I. SEVERITY OF ILLNESS CATEGORIES).

You may not qualify if:

• Hospitalized patients.
• Breast-feeding or pregnant (any woman of childbearing age and potential must have a negative test within 24 hours of starting treatment).
• Allergy to any of the components of the study medication.
• AST or ALT \> x3 the upper limit value
• Estimated Glomerular Filtration Rate (eGFR) \< 30
• Concomitant antiviral therapy such as lopinavir or ritonavir
• Concomitant immunosuppressive or immunomodulatory drugs (e.g., interleukins, interleukin antagonists or receptor blockers, anticancer drugs, immunosuppressant)
• Concomitant therapy with corticosteroids at a dose \> 20mg per day was administered for more than 14 days before the study medication.
• Human immunodeficiency virus infection under highly active antiretroviral therapy (HAART).
• Has participated in another clinical trial within the last 30 days.

Sponsors & Collaborators

• Jose David Suarez, MD: lead
• Sesderma S.L.: collaborator
• Westchester General Hospital Inc. DBA Keralty Hospital Miami: collaborator
• MGM Technology Corp: collaborator

Study Sites (1)

Keralty Hospital Miami

Miami, Florida, 33155, United States

Location

Related Publications (1)

• Martorell P, Llopis S, Gonzalez N, Ramon D, Serrano G, Torrens A, Serrano JM, Navarro M, Genoves S. A nutritional supplement containing lactoferrin stimulates the immune system, extends lifespan, and reduces amyloid beta peptide toxicity in Caenorhabditis elegans. Food Sci Nutr. 2016 Jul 28;5(2):255-265. doi: 10.1002/fsn3.388. eCollection 2017 Mar.

  PMID: 28265360 BACKGROUND

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Jose D Suarez

  Keralty Hospital, Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two teams will be involved in the trial unblinded team that will randomized the subjects and dispense the investigational product and the blinded team that will be involved in the clinical evaluations and data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Treatment Group: Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20). Control group: Placebo +SOC (N=20) Intervention groups At baseline, subjects will be randomized in a 1:1 ratio to either treatment or control groups.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 24, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (1)