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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

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

What is the study measuring?
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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). | 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 | 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 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 | 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 | Assessment of adverse events. | through study completion, an average of 70 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposomal lactoferrin, liposomal Zinc, COVID-19