NCT05783180

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jose David Suarez, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™	Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD)
DRUG	Placebo	Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-06-01
• Completion: 2024-11-01
• First posted: 2023-03-24
• Last updated: 2023-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study