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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04526821
Recruitment Status : Terminated (The study was interrupted due to the arrival and distribution of the vaccine to hospital workers in Peru)
First Posted : August 26, 2020
Last Update Posted : December 9, 2021
Sponsor:
Collaborator:
Hospital Nacional Arzobispo Loayza
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: Bovine Lactoferrin Dietary Supplement: Maltodextrin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : October 17, 2020
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bovine Lactoferrin
Bovine Lactoferrin plus standard measures of personal protection.
 Drug: Bovine Lactoferrin
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 Name: Lactoferrin
Placebo Comparator: Maltodextrin
Maltodextrin plus standard measures of personal protection.
 Dietary Supplement: Maltodextrin
Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Frecuency of symptoms of the COVID-19 infection [ Time Frame: Twelve weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526821


Locations
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Peru
Hospital Nacional Arzobispo Loayza
Lima, Lim, Peru, 15082
Hospital Cayetano Heredia
Lima, Peru, 15102
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Hospital Nacional Arzobispo Loayza
Investigators
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Principal Investigator: Theresa J Ochoa, MD, PhD Universidad Peruana Cayetano Heredia
More Information
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Publications:
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

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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT04526821    
Other Study ID Numbers: SIDISI 202110
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Immediately following publication of the study,
Access Criteria: Contact the study PI ( Theresa.ochoa@upch.pe)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Peruana Cayetano Heredia:
SARS-CoV-2 Infection
Lactoferrin
Health Care Workers
Additional relevant MeSH terms:
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Lactoferrin
Anti-Infective Agents