Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19
Efficacy of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jul 2020
Shorter than P25 for phase_2 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJune 16, 2020
June 1, 2020
2 months
June 10, 2020
June 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of SARS-CoV-2
Number of confirmed infections of SARS-CoV-2 in healthcare workers
28 days
Secondary Outcomes (1)
Severity of disease in confirmed infected participants
28 days
Study Arms (2)
Lactoferrin prophylaxis
EXPERIMENTAL200 mg oral lactoferrin daily
Control group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known allergy or hypersensitivity to the used medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Endemic Medicine
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 11, 2020
Study Start
July 1, 2020
Primary Completion
September 1, 2020
Study Completion
November 1, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06