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

NCT ID: NCT05783180

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-11-30

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

Detailed Description

This is a placebo-controlled, randomized, parallel-group, adaptive, phase 2 study to evaluate the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (LbLf+LZn) + SOC compared to Placebo+SOC in non-hospitalized patients with COVID-19. The primary endpoint is the reduction in the signs and symptoms of COVID-19 from baseline to D11/D28 (end of treatment).

The study duration will be up to 70 days including.

• Screening and randomization (Day0/D1): Screening and the first day of treatment
• Treatment period: from (D0 to D10). Treatment will be administered for up to 10 days, and treatment evaluation visits on D11 (EOT) and D28.
• Follow-up (FU): Will start after treatment completion on day 10. Two visits are scheduled during this period: one 28 days after the last dose (D38) and the other 60 days after the last dose (D70).

Patient population None hospitalized Individuals with mild to moderate SARS-CoV-2 infection with less than 7 days of symptoms evolution. This corresponds to a score of 1 or 2 (moderate to mild disease) on the WHO 9-point ordinal scale

Number of subjects Approximately: 40

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™

Intervention Type: DRUG

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

Control

Placebo +SOC (N=20)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sesderma S.L.

UNKNOWN

Sponsor Role: collaborator

Westchester General Hospital Inc. DBA Keralty Hospital Miami

UNKNOWN

Sponsor Role: collaborator

MGM Technology Corp

UNKNOWN

Sponsor Role: collaborator

Jose David Suarez, MD

OTHER

Sponsor Role: lead

Responsible Party

Jose David Suarez, MD

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jose D Suarez

Role: PRINCIPAL_INVESTIGATOR

Keralty Hospital, Miami

Locations

Keralty Hospital Miami

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28265360 (View on PubMed)

Other Identifiers

SES-LFZN-001

Identifier Type: -

Identifier Source: org_study_id