- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04526821
Lactoferrin for Prevention of COVID-19 in Health Care Workers (LF-COVID)
December 1, 2021 updated by: Universidad Peruana Cayetano Heredia
Bovine Lactoferrin for the Prevention of COVID-19 Infection in Physicians and Nurses in Hospitals in Lima, Peru: a Double Blinded Randomized Clinical Trial (LF-COVID)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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 Type
Interventional
Enrollment (Actual)
209
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lima, Peru, 15102
- Hospital Cayetano Heredia
-
-
Lim
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Lima, Lim, Peru, 15082
- Hospital Nacional Arzobispo Loayza
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Man or woman over 18 and under 60 years old
- Physicians or nurses or nurse assitant who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru.
- Healthy participants, without COVID-19 suggestive symptoms
- Participant who wants to participate and signs the informed consent.
Exclusion Criteria:
- Participant who had a previous diagnosis of COVID-19.
- Participant positive in the initial screening for IgM or IgG or a positive RT-PCR for SARS-CoV-2.
- Participant with the following comorbidities: hypertension, coronary heart disease, diabetes mellitus, obesity, chronic lung disease, cancer, kidney failure, or other hematological disease.
- Pregnant woman.
- Participant that are part of another clinical trial or are taking any supplement or preventive treatment for COVID-19.
- Participant with known allergy to cow's milk protein.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bovine Lactoferrin
Bovine Lactoferrin plus standard measures of personal protection.
|
Bovine Lactoferrin 600mg daily for 12 weeks (3 chewable tablets of 100mg , twice a day), for 12 weeks plus personal portection provided from the hospital.
Other Names:
|
Placebo Comparator: Maltodextrin
Maltodextrin plus standard measures of personal protection.
|
Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of COVID-19 infections during the 12 weeks of intervention
Time Frame: Twelve weeks
|
The primary study outcome will be defined by IgM, IgG and/or RT-PCR positivity for SARS-CoV 2.
|
Twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of the COVID-19 infection
Time Frame: Twelve weeks
|
Severity of SARS-CoV-2 infection (asymptomatic, mild, moderate, severe infection), assessed by the World Health Organization definitions
|
Twelve weeks
|
Duration of symptoms of the COVID-19 infection
Time Frame: Twelve weeks
|
Duration of symptomatic SARS-CoV-2 infection defined by the number of days with SARS-CoV-2 symptomatology.
|
Twelve weeks
|
Frecuency of symptoms of the COVID-19 infection
Time Frame: Twelve weeks
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Frecuency of symptoms of SARS-CoV-2 infection: fever, fatigue, nonproductive cough, anorexia, myalgias, dyspnea, productive cough, taste and smell disorders, headache, rhinorrhea, nausea, diarrhea, and abdominal pain
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Twelve weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Theresa J Ochoa, MD, PhD, Universidad Peruana Cayetano Heredia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Legrand D. Overview of Lactoferrin as a Natural Immune Modulator. J Pediatr. 2016 Jun;173 Suppl:S10-5. doi: 10.1016/j.jpeds.2016.02.071.
- Baker HM, Baker EN. A structural perspective on lactoferrin function. Biochem Cell Biol. 2012 Jun;90(3):320-8. doi: 10.1139/o11-071. Epub 2012 Jan 31.
- Chang R, Ng TB, Sun WZ. Lactoferrin as potential preventative and adjunct treatment for COVID-19. Int J Antimicrob Agents. 2020 Sep;56(3):106118. doi: 10.1016/j.ijantimicag.2020.106118. Epub 2020 Jul 30.
- Lang J, Yang N, Deng J, Liu K, Yang P, Zhang G, Jiang C. Inhibition of SARS pseudovirus cell entry by lactoferrin binding to heparan sulfate proteoglycans. PLoS One. 2011;6(8):e23710. doi: 10.1371/journal.pone.0023710. Epub 2011 Aug 22.
- Campione E, Cosio T, Rosa L, Lanna C, Di Girolamo S, Gaziano R, Valenti P, Bianchi L. Lactoferrin as Protective Natural Barrier of Respiratory and Intestinal Mucosa against Coronavirus Infection and Inflammation. Int J Mol Sci. 2020 Jul 11;21(14):4903. doi: 10.3390/ijms21144903.
- Mirabelli C, Wotring JW, Zhang CJ, McCarty SM, Fursmidt R, Frum T, Kadambi NS, Amin AT, O'Meara TR, Pretto CD, Spence JR, Huang J, Alysandratos KD, Kotton DN, Handelman SK, Wobus CE, Weatherwax KJ, Mashour GA, O'Meara MJ, Sexton JZ. Morphological Cell Profiling of SARS-CoV-2 Infection Identifies Drug Repurposing Candidates for COVID-19. bioRxiv. 2020 Dec 7:2020.05.27.117184. doi: 10.1101/2020.05.27.117184. Preprint.
- Marques de Carvalho CA, da Rocha Matos A, Caetano BC, de Sousa Junior IP, da Costa Campos SP, Geraldino BR, et al. In Vitro Inhibition of SARS-CoV-2 Infection by Bovine Lactoferrin [Internet]. Microbiology; 2020 May [cited 2020 May 25]. Available from: http://biorxiv.org/lookup/doi/10.1101/2020.05.13.093781
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2020
Primary Completion (Actual)
February 10, 2021
Study Completion (Actual)
February 10, 2021
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 21, 2020
First Posted (Actual)
August 26, 2020
Study Record Updates
Last Update Posted (Actual)
December 9, 2021
Last Update Submitted That Met QC Criteria
December 1, 2021
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIDISI 202110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodological sound study protocol previously approved by an independent ethics committee.
IPD Sharing Time Frame
Immediately following publication of the study,
IPD Sharing Access Criteria
Contact the study PI ( Theresa.ochoa@upch.pe)
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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