Lactoferrin Use in (SARS-CoV-2) Management

Not Applicable

• Conditions: Covid19

• Registration Number: NCT04860219
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-08
• Primary Completion: 2020-09-18
• Status Verified: 2021-04
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-23
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-27
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Exclusion criteria:

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
time to be symptoms free and normal laboratory results	7 days after enrollment	duration from day 0 symptoms till 7 days symptoms free and normal laboratory findings

Trial Locations

Locations (1)

Faculty of Medicine -Zagazig University; 🇪🇬 Zagazig, Egypt