Lactoferrin Use in (SARS-CoV-2) Management

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Lactoferrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>None of the participants in the Control Group received lactoferrin | |
| Active Comparator: 200 mg lactoferrin orally once daily Group<br>received 200 mg lactoferrin orally once daily | Dietary Supplement: Lactoferrin<br>* 7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR<br>|
| Active Comparator: 200 mg lactoferrin orally twice daily Group<br>received 200 mg lactoferrin orally twice daily | Dietary Supplement: Lactoferrin<br>* 7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to be symptoms free and normal laboratory results | duration from day 0 symptoms till 7 days symptoms free and normal laboratory findings | 7 days after enrollment |