Lactoferrin Use in (SARS-CoV-2) Management

NCT04860219 | Unknown

• 1 other identifier: COVID-1937
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control Group

NO INTERVENTION

None of the participants in the Control Group received lactoferrin

200 mg lactoferrin orally once daily Group

ACTIVE COMPARATOR

received 200 mg lactoferrin orally once daily

Dietary Supplement: Lactoferrin

200 mg lactoferrin orally twice daily Group

ACTIVE COMPARATOR

received 200 mg lactoferrin orally twice daily

Dietary Supplement: Lactoferrin

Interventions

Lactoferrin DIETARY_SUPPLEMENT

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

200 mg lactoferrin orally once daily Group; 200 mg lactoferrin orally twice daily Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine -Zagazig University

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Central Study Contacts

mohamed ghoniem, MD

CONTACT

00966540845657; teto2006.km@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine- Faculty of Medicine

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: July 8, 2020
• Primary Completion: September 18, 2020
• Study Completion: April 30, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)