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Lactoferrin Use in (SARS-CoV-2) Management

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04860219
Acronym
SARS-CoV-2
Enrollment
54
Registered
2021-04-26
Start date
2020-07-08
Completion date
2021-04-30
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DIETARY_SUPPLEMENTLactoferrin

7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
time to be symptoms free and normal laboratory results7 days after enrollmentduration from day 0 symptoms till 7 days symptoms free and normal laboratory findings

Countries

Egypt

Contacts

Primary Contactmohamed ghoniem, MD
teto2006.km@gmail.com00966540845657

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026