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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

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

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%.
  • Exclusion criteria:
  • 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.

排除标准

  • 未提供

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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