Lactoferrin Use in (SARS-CoV-2) Management

Not Applicable

• Conditions: Covid19
• Interventions: Dietary Supplement: Lactoferrin

• 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

Arm && Interventions

Group	Intervention	Description
200 mg lactoferrin orally twice daily Group	Lactoferrin	received 200 mg lactoferrin orally twice daily
200 mg lactoferrin orally once daily Group	Lactoferrin	received 200 mg lactoferrin orally once daily

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