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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Two teams will be involved in the trial unblinded team that will randomized the subjects and dispense the investigational product and the blinded team that will be involved in the clinical evaluations and data collection.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
Sesderma LACTYFERRIN™ Forte (64mg/20ml, TID) and Sesderma ZINC Defense™ (20mg/20ml QD) + SOC (N=20).
干预措施: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Drug)
Control
Placebo +SOC (N=20)
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in the signs and symptoms of COVID-19 from baseline to Day 11 (end of treatment, EOT).
时间窗: 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
次要结局
- 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)
- The change in blood levels of inflammatory biomarkers(5,11 and 28 days after first study medication dose)
- The proportion of patients with disease progression on Day 28(up to 28 days after first study medication dose)
- Adverse event(through study completion, an average of 70 days)
研究者
Jose David Suarez, MD
Principal investigator
Keralty Hospital, Miami