Lactoferrin Use in (SARS-CoV-2) Management

Covid19 Clinical Trial

— SARS-CoV-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860219
• Other study ID #: COVID-1937
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2021
• Source: Zagazig University
• Contact: mohamed ghoniem, MD
• Phone: 00966540845657
• Email: teto2006.km[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 30, 2021
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine -Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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