Clinical trial NCT05783180: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Keywords: Liposomal lactoferrin
liposomal Zinc
COVID-19
Lead sponsor: Keralty Hospital, Miami
Sponsor class: OTHER
Collaborators: name: Sesderma S.L.
name: Westchester General Hospital Inc. DBA Keralty Hospital Miami
name: MGM Technology Corp
First posted: 2023-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
timeFrame: 11 days (one day after last study medication dose)
Secondary outcomes:
measure: The proportion of patients with disease progression on Day 28
timeFrame: up to 28 days after first study medication dose
measure: Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale
timeFrame: 5,11 and 28 days after first study medication dose
measure: The change in blood levels of inflammatory biomarkers
timeFrame: 5,11 and 28 days after first study medication dose
measure: Adverse event
timeFrame: through study completion, an average of 70 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Keralty Hospital Miami
state: Florida
Study officials:
affiliation: Keralty Hospital, Miami
name: Jose D Suarez
role: PRINCIPAL_INVESTIGATOR
References:
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.