LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
- Conditions
- COVID-19
- Interventions
- Drug: PlaceboDrug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™
- Registration Number
- NCT05783180
- Lead Sponsor
- Jose David Suarez, MD
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo Placebo +SOC (N=20) Treatment Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
- Primary Outcome Measures
Name Time Method Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT). 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
- Secondary Outcome Measures
Name Time Method The proportion of patients with disease progression on Day 28 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.
Adverse event through study completion, an average of 70 days Assessment of adverse events.
Time to recover or Odds of Ratio for Improvement in WHO 9-point ordinal scale 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.
The change in blood levels of inflammatory biomarkers 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.
Trial Locations
- Locations (1)
Keralty Hospital Miami
🇺🇸Miami, Florida, United States