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临床试验/NCT04860219
NCT04860219Unknown不适用

The Prospect of Lactoferrin Use as Adjunctive Agent in Management of SARS COV-2 Patients: A Randomized Pilot Study

Zagazig University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
54
试验地点
1
主要终点
time to be symptoms free and normal laboratory results

研究概览

简要总结

Background: Preventive, adjunctive and curative properties of lactoferrin have been evaluated since the first wave of severe acute respiratory syndrome coronavirus (SARS-CoV), viral respiratory disease, emerged 18 years ago. Despite the discovery of new vaccine candidates, there is currently no widely approved treatment for SARS-CoV-2 (COVID-19). Strict adherence to infection prevention and control procedures, as well as vaccines, can, however, prevent the spread of SARS-CoV-2. Objective: Hence, this study evaluated the efficacy of lactoferrin treatment in improving clinical symptoms and laboratory indices among individuals with mild to moderate coronavirus disease-19 (COVID-19). Design and Participants: A randomized, prospective, interventional pilot study conducted between July 8 and September 18, 2020 used a hospital-based sample of 54 laboratory confirmed participants with mild to moderate symptoms of COVID-19. Randomization into a control and two treatment groups ensured all groups received the approved Egyptian COVID-19 management protocol; only treatment group participants received lactoferrin at different doses for seven days. Clinical symptoms and laboratory indices were assessed on Days 0, 2 and 7 after starting treatments. Mean values with standard deviation and one-way analysis of variance with least significant difference post hoc of demographic and laboratory data between control and treatment groups were calculated. Key Results: Our study showed no stastically significant difference among studied groups regarding recovery of symptoms or laboratory improvement. Conclusion: Further research into therapeutic properties particularly related to dosage, duration and follow-up after treatment with lactoferrin in individuals with COVID-19 is required.

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
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •participants over 20 years of age
  • •positive for nasopharyngeal swab reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19
  • •blood oxygen saturation (SpO2) > 93%.

排除标准

  • •pregnant and breastfeeding women
  • •individuals confirmed to be allergic to milk protein
  • •those with a medical history of bronchial hyperactivity or pre-existing respiratory diseases
  • •ICU inpatients with COVID-19.

研究组 & 干预措施

Control Group

No Intervention

None of the participants in the Control Group received lactoferrin

200 mg lactoferrin orally twice daily Group

Active Comparator

received 200 mg lactoferrin orally twice daily

干预措施: Lactoferrin (Dietary Supplement)

200 mg lactoferrin orally once daily Group

Active Comparator

received 200 mg lactoferrin orally once daily

干预措施: Lactoferrin (Dietary Supplement)

结局指标

主要结局

time to be symptoms free and normal laboratory results

时间窗: 7 days after enrollment

duration from day 0 symptoms till 7 days symptoms free and normal laboratory findings

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed E Ghoniem

Associate Professor of Internal Medicine- Faculty of Medicine

Zagazig University

研究点 (1)

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