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

March 22, 2023 updated by: Jose David Suarez, MD

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Keralty Hospital Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
Drug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD)
Placebo Comparator: Control
Placebo +SOC (N=20)
Drug: Placebo
Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
Time Frame: 11 days (one day after last study medication dose)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with disease progression on Day 28
Time Frame: up to 28 days after first study medication dose
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.
up to 28 days after first study medication dose
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale
Time Frame: 5,11 and 28 days after first study medication dose
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale from Baseline to D5/D11 (EOT)/D28.
5,11 and 28 days after first study medication dose
The change in blood levels of inflammatory biomarkers
Time Frame: 5,11 and 28 days after first study medication dose
The change in blood levels CRP, CRP/albumin, ferritin, iron, and D-Dimer from baseline, D5, D11 (EOT), and 28.
5,11 and 28 days after first study medication dose
Adverse event
Time Frame: through study completion, an average of 70 days
Assessment of adverse events.
through study completion, an average of 70 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose David Suarez, MD

Collaborators

Sesderma S.L.
Westchester General Hospital Inc. DBA Keralty Hospital Miami
MGM Technology Corp

Investigators

  • Principal Investigator: Jose D Suarez, Keralty Hospital, Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SES-LFZN-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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