Lactoferrin for Prevention of COVID-19 in Health Care Workers

Status Terminated

Clinical Trial Summary

Clinical trial in health care personnel (physicians, nurses or nurse assistants) to determine the effect of orally-administered bovine lactoferrin to prevent SARS-CoV-2 infection. Participants will be randomized to receive daily bovine lactoferrin plus standard measures during 12 weeks or placebo (maltodextrine) for the prevention of SARS-CoV-2. The target enrollment is 336 participants. Each study participant will be monitored twice a week for symptoms of COVID-19 and if symptoms occur, a RT-PCR will be performed. Additionally, we will evaluate asymptomatic infections, by measuring SARS-CoV-2 serology every 4 weeks.

Clinical Trial Description

The SARS-CoV-2 infection has affected more than 100 countries around the world being classified as a pandemic by the World Health Organization. Health care providers are at high risk to become infected with the SARS-CoV-2 due to their continuous exposition to infected patients. Multiple strategies are being developed as potential prophylactic regimens, however to date (4th Aug 2020) none has proven to be effective for preventing the SARS-CoV-2 infection. Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. It has shown to inhibit the SARS entry to target cells by inhibiting the union of the SARS-CoV-2 spike protein with its receptor (ACE-II receptors), blocking the heparan sulfate proteoglycan receptor and it decreases the viral load of SARS-CoV-2 infecting culture cells in in vitro models. The study hypothesis is that lactoferrin given as a daily oral food supplement to health care workers will decrease the frequency of SARS-CoV-2 infection. The investigators will conduct a randomized double blinded placebo control clinical trial in physicians, nurses and nurse assistants who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru, to determine the effect of bovine lactoferrin on the prevention of COVID-19 infection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04526821
Study type	Interventional
Source	Universidad Peruana Cayetano Heredia
Contact
Status	Terminated
Phase	Phase 2
Start date	October 17, 2020
Completion date	February 10, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Completed	`NCT04527471` - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19	Phase 2
Recruiting	`NCT05584202` - Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants	Phase 2
Completed	`NCT04579549` - Repeat Testing for SARS-CoV-2	N/A
Active, not recruiting	`NCT05547243` - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China	N/A
Recruiting	`NCT04613310` - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19)	N/A
Recruiting	`NCT04747574` - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection	Phase 1
Completed	`NCT04515147` - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19	Phase 2
Terminated	`NCT04447404` - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury	Phase 2
Withdrawn	`NCT04388709` - Interferon Lambda Therapy for COVID-19	Phase 2
Active, not recruiting	`NCT05550142` - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China	N/A
Completed	`NCT04620798` - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students	N/A
Active, not recruiting	`NCT05547256` - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China	N/A
Completed	`NCT04452604` - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed	`NCT04561102` - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed	`NCT05366322` - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Terminated	`NCT04958304` - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed	`NCT04526769` - Detecting SARS-CoV-2 in Tears
Completed	`NCT04690413` - NOWDx Test for the Detection of Antibodies to COVID-19	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Lactoferrin for Prevention of COVID-19 in Health Care Workers — LF-COVID

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms