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SARS-CoV-2Phase 2LF-COVIDNCT04526821

Lactoferrin for Prevention of COVID-19 in Health Care Workers

A Phase 2 study testing Bovine Lactoferrin and Maltodextrin in people with SARS-CoV-2, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
Bovine Lactoferrin and Maltodextrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
209 participants
Where
2 sitesPeru
Study dates
17 Oct 2020to 10 Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Peru2 sites

  • Hospital Nacional Arzobispo Loayza

    Lima, Lim, 15082

  • Hospital Cayetano Heredia

    Lima, 15102

Other trials in Peru

About this study

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)

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.

Read the 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.

Conditions
SARS-CoV-2
Being tested
Bovine Lactoferrin, Maltodextrin
Keywords
SARS-CoV-2 Infection, Lactoferrin, Health Care Workers
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bovine LactoferrinDrug

    Also called 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.

  • MaltodextrinDietary supplement

    Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.

Study groups in NCT04526821
Study groupRoleWhat they receive
Bovine LactoferrinExperimentalBovine Lactoferrin plus standard measures of personal protection.
Receives: Drug: Bovine Lactoferrin
MaltodextrinPlacebo comparatorMaltodextrin plus standard measures of personal protection.
Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of COVID-19 infections during the 12 weeks of intervention

    The primary study outcome will be defined by IgM, IgG and/or RT-PCR positivity for SARS-CoV 2.

    Measured: Twelve weeks

Secondary outcomes (3)

  1. Severity of the COVID-19 infection

    Severity of SARS-CoV-2 infection (asymptomatic, mild, moderate, severe infection), assessed by the World Health Organization definitions

    Measured: Twelve weeks

  2. Duration of symptoms of the COVID-19 infection

    Duration of symptomatic SARS-CoV-2 infection defined by the number of days with SARS-CoV-2 symptomatology.

    Measured: Twelve weeks

  3. Frecuency of symptoms of the COVID-19 infection

    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

    Measured: Twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2020
  2. Study start17 Oct 2020
  3. Primary completion10 Feb 2021
  4. Study completion10 Feb 2021

Why it stopped: The study was interrupted due to the arrival and distribution of the vaccine to hospital workers in Peru

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04526821
Sponsor's protocol ID
SIDISI 202110
Acronym
LF-COVID
Status last verified
Aug 2020
First submitted
21 Aug 2020
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 27234406

  • 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.

    PubMed 22292559

  • 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.

    PubMed 32738305

  • 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.

    PubMed 21887302

  • 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.

    PubMed 32664543

  • 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 [Preprint]. 2020 Dec 7:2020.05.27.117184. doi: 10.1101/2020.05.27.117184.

    PubMed 32577649

  • 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

  • Navarro R, Paredes JL, Tucto L, Medina C, Angles-Yanqui E, Nario JC, Ruiz-Cabrejos J, Quintana JL, Turpo-Espinoza K, Mejia-Cordero F, Aphang-Lam M, Florez J, Carrasco-Escobar G, Ochoa TJ. Bovine lactoferrin for the prevention of COVID-19 infection in health care personnel: a double-blinded randomized clinical trial (LF-COVID). Biometals. 2023 Jun;36(3):463-472. doi: 10.1007/s10534-022-00477-3. Epub 2022 Dec 7.

    PubMed 36474100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bovine Lactoferrin and Maltodextrin in people with SARS-CoV-2, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was interrupted due to the arrival and distribution of the vaccine to hospital workers in Peru). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of COVID-19 infections during the 12 weeks of intervention (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04526821, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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