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Clinical Trials/NCT04860219
NCT04860219UnknownNot Applicable

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

Zagazig University1 site in 1 country54 target enrollmentStarted: July 8, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
54
Locations
1
Primary Endpoint
time to be symptoms free and normal laboratory results

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

time to be symptoms free and normal laboratory results

Time Frame: 7 days after enrollment

duration from day 0 symptoms till 7 days symptoms free and normal laboratory findings

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Mohamed E Ghoniem

Associate Professor of Internal Medicine- Faculty of Medicine

Zagazig University

Study Sites (1)

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