Utility of Lactoferrin as an Adjunct Therapeutic Agent for COVID-19

NCT04421534 | Unknown Phase 2 DMC

• 1 other identifier: CUKA-001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, remains the most important management strategy. Since its discovery, lactoferrin and its related peptides are mainly considered to be important non-specific host defense molecules against a broad range of viruses including SARS-CoV, which is closely related to SARS-CoV-2 that causes COVID-19. Lactoferrin has been found to experimentally inhibit viral entry in murine coronavirus, and human coronaviruses hCOV-NL63 and pseudotyped SARS-CoV. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry. Another major aspect of lactoferrin bioactivity relates to its immunomodulatory and anti-inflammatory functions. Current thinking suggests that mortality from COVID-19 is not simply due to viral infection but is a result of a cytokine storm associated with hyper-inflammation leading to acute respiratory distress and subsequent mortality. A cytokine profile in severe COVID-19 cases is characterized by increases in cytokines and acute phase reactants and ferritin. In this regard, lactoferrin was demonstrated to reduce IL-6, TNF a, and downregulate ferritin in experimental settings simulating sepsis. In this study, we aim to study the potential application of lactoferrin against SARS-CoV-2 and propose the possibility of using different doses of supplemental lactoferrin as a potential adjunct treatment for COVID-19.

Conditions

COVID-19

Keywords

COVID-19; lactoferrin

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  time from randomization to improvement of two points on used scale or live discharge from the hospital, whichever came first.

  28 days

Secondary Outcomes (1)

• Rate of virological cure

  28 days

Study Arms (3)

Standard of care in addition to 400 mg lactoferrin

EXPERIMENTAL

Standard of care treatment; as per MOHP protocol, in addition to 400 mg oral lactoferrin daily \[two sachets 100 mg granules (Pravotin sachets, Hygint, Egypt) in 1/4 glass of water twice a day before meals\]

Drug: Lactoferrin

Standard of care in addition to 600 mg lactoferrin

EXPERIMENTAL

Standard of care treatment; as per MOHP protocol, in addition to 600 mg oral lactoferrin daily \[three sachets 100 mg granules (Pravotin sachets, Hygint, Egypt) in 1/4 glass of water twice a day before meals\]

Drug: Lactoferrin

Standard of care only

ACTIVE COMPARATOR

Standard of care treatment; as per MOHP protocol

Drug: Lactoferrin

Interventions

Lactoferrin DRUG

adding lactoferrin to standard of care treatment regimens

Also known as: Standard of care treatment regimens

Standard of care in addition to 400 mg lactoferrin; Standard of care in addition to 600 mg lactoferrin; Standard of care only

Eligibility Criteria

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

You may qualify if:

• Positive reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay for SARS- CoV-2 in a respiratory tract sample.

You may not qualify if:

• Known allergy or hypersensitivity to the used medications
• Severe symptoms: respiratory insufficiency that requires admission in intensive care unit or mechanical ventilation

Sponsors & Collaborators

• Cairo University: lead

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endemic Medicine

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06