Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
prophylactic lactoferrin daily
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- health care workers at risk of SARS-CoV-2 transmission with no previous diagnosis of SARS-CoV-2 infection
- No symptoms compatible with SARS-CoV-2 (COVID-19) until the date of enrolment in the study.
Exclusion Criteria:
- Known allergy or hypersensitivity to the used medications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lactoferrin prophylaxis
Control group
Arm Description
200 mg oral lactoferrin daily
Outcomes
Primary Outcome Measures
Incidence of SARS-CoV-2
Number of confirmed infections of SARS-CoV-2 in healthcare workers
Secondary Outcome Measures
Severity of disease in confirmed infected participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04427865
Brief Title
Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19
Official Title
Efficacy of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
COVID 19, which probably started from zoonotic transmission related to crowded markets in China was announced as a pandemic by the WHO on 11 March 2020.
There is currently no clinically proven specific antiviral agents available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy.
Since its discovery, lactoferrin and its related peptides are considered 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. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry and has an immunomodulatory effect that can prevent the cytokine storm associated with COVID-19.
The aim of our study is to assess the safety and efficacy of lactoferrin within the context of SARS-CoV-2 and propose the possibility of supplemental lactoferrin as a potential preventive drug for healthcare workers exposed to SARS-CoV-2.
Detailed Description
In December, 2019, an outbreak of pneumonia with unknown cause occurred in Wuhan city, in China. On January 7th, the scientists succeeded to isolate a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO nominated it as coronavirus disease 2019 (COVID-19) in February, 2020. COVID-19 has a wide clinical spectrum ranging between asymptomatic infection, mild upper respiratory tract symptoms, and severe viral pneumonia that may result in respiratory failure and finally death. There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy.
Lactoferrin is a highly conserved pleiotropic iron-binding 80-kDa glycoprotein of the transferrin family that is expressed and secreted by glandular cells and found in most body fluids with especially high concentrations in mammalian milk. 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. Given the homology of SARS-CoV and SARS-CoV-2 spike protein structures, as well as both viruses depending on the same ACE2 receptor for cell entry, it is likely that lactoferrin can inhibit SARS-CoV-2 invasion as in the case of SARS-CoV. Besides reducing viral entry, lactoferrin can also suppress virus replication after the viral entry as in the case of HIV.
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 such as interleukin IL-6, tumor necrosis factor-a (TNFa) 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 antiviral properties and immunomodulatory mechanisms of lactoferrin within the context of its potential applications against SARS-CoV-2 and propose the possibility of supplemental lactoferrin as a potential preventive agent for COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactoferrin prophylaxis
Arm Type
Experimental
Arm Description
200 mg oral lactoferrin daily
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
prophylactic lactoferrin daily
Intervention Description
200 mg oral lactoferrin daily
Primary Outcome Measure Information:
Title
Incidence of SARS-CoV-2
Description
Number of confirmed infections of SARS-CoV-2 in healthcare workers
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Severity of disease in confirmed infected participants
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
health care workers at risk of SARS-CoV-2 transmission with no previous diagnosis of SARS-CoV-2 infection
No symptoms compatible with SARS-CoV-2 (COVID-19) until the date of enrolment in the study.
Exclusion Criteria:
Known allergy or hypersensitivity to the used medications
12. IPD Sharing Statement
Learn more about this trial
Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19
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