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

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™
Placebo
Sponsored by
Jose David Suarez, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Liposomal lactoferrin, liposomal Zinc, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Keralty Hospital Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

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

Placebo +SOC (N=20)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The proportion of patients with disease progression on Day 28
The proportion of patients with disease progression on Day 28, are defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, or ECMO.
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale from Baseline to D5/D11 (EOT)/D28.
The change in blood levels of inflammatory biomarkers
The change in blood levels CRP, CRP/albumin, ferritin, iron, and D-Dimer from baseline, D5, D11 (EOT), and 28.
Adverse event
Assessment of adverse events.

Full Information

First Posted
March 9, 2023
Last Updated
March 22, 2023
Sponsor
Jose David Suarez, MD
Collaborators
Sesderma S.L., Westchester General Hospital Inc. DBA Keralty Hospital Miami, MGM Technology Corp
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1. Study Identification

Unique Protocol Identification Number
NCT05783180
Brief Title
LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
Official Title
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Liposomal Bovine Lactoferrin (LbLf) and Liposomal Zn (LZn)) and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose David Suarez, MD
Collaborators
Sesderma S.L., Westchester General Hospital Inc. DBA Keralty Hospital Miami, MGM Technology Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Liposomal lactoferrin, liposomal Zinc, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo +SOC (N=20)
Intervention Type
Drug
Intervention Name(s)
Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™
Intervention Description
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)
Primary Outcome Measure Information:
Title
Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
Description
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
Time Frame
11 days (one day after last study medication dose)
Secondary Outcome Measure Information:
Title
The proportion of patients with disease progression on Day 28
Description
The proportion of patients with disease progression on Day 28, are defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as the need for invasive or non-invasive mechanical ventilation, high-flow oxygen, or ECMO.
Time Frame
up to 28 days after first study medication dose
Title
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale
Description
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale from Baseline to D5/D11 (EOT)/D28.
Time Frame
5,11 and 28 days after first study medication dose
Title
The change in blood levels of inflammatory biomarkers
Description
The change in blood levels CRP, CRP/albumin, ferritin, iron, and D-Dimer from baseline, D5, D11 (EOT), and 28.
Time Frame
5,11 and 28 days after first study medication dose
Title
Adverse event
Description
Assessment of adverse events.
Time Frame
through study completion, an average of 70 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria T Bertoli Avella
Phone
7864742612
Email
maria.bertoli@keraltyhospital.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo A Masferrer
Phone
7864514850
Email
gmasferrer@keraltyhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose D Suarez
Organizational Affiliation
Keralty Hospital, Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keralty Hospital Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28265360
Citation
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.
Results Reference
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LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19

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