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.

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.

The datasets generated and/or analyzed during the current study are available from the corresponding author upon request.