Lactoferrin in Covid-19 Hospitalized Patients

NCT04847791 | Unknown DMC

• 1 other identifier: 2020/279
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

TRIAL LAC is a randomized double-blind non profit multicenter study with a nutritional product: bovine lactoferrin - Mosiac 200 mg. the hypothesis to be confirmed is that bovine LF, administered daily orally in addition to standard therapies for 1 month to hospitalized patients with Covid-19 infection, can be useful to limit the severity, progression of the disease, shorten the time of swabs negativization (i.e. time required to eliminate the virus) and to reduce the morbidity load associated with it. Patient recruitment will involve 2 centers in Italy: Ospedale degli Infermi (Ponderano, Biella) and AOU Maggiore della Carità (Novara). The subjects enrolled will be randomized to two Groups: Group A (experimental arm) - Standard Anti-Covid-19 Therapy + Oral Administration of Bovine Lactoferrin (fixed dose 800 mg / day) for 30 days Group B (control arm) - Standard anti-Covid-19 therapy + Placebo administration (identical capsule with the same amount as an inert compound, starch of corn powder), according to the same pattern of use. It should be specified that the study treatment and placebo will be administered in addition to the standard care in place, and therefore in addition to all the pharmacological treatments currently used in clinical hospital practice against Covid-19.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• intensive care unit hospitalization rate

  The primary endpoint will be to evaluate the efficacy of bovine LF orally (BLF- Mosiac) compared to placebo in affecting at least one of the following: 1\) it is expected a reduction of a composite event rate consisting of two items: the number of hospitalizations in intensive care unit due to any cause and the number of deaths

  1 year

• death

  number of deaths during hospitalization

  1 year

• proportion of discharged patients

  The primary endpoint will be to evaluate the efficacy of bovine LF orally (BLF- Mosiac) compared to placebo in affecting at least one of the following: 2\) it is expected an increase of proportion of discharged patients within 14 days and an increase of number of patients reaching a National Early Warning Score (NEWS) of 2 or less

  1 year

• National Early Warning Score (NEWS)

  it is expected an increase of number of patients reaching a National Early Warning Score (NEWS) of 2 or less, maintained for at least 24hrs

  during hospitalization

Secondary Outcomes (9)

• daily clinical severity score

  during hospitalization

• oxygen

  during hospitalization

• ferritin

  during hospitalization

• IL 6

  during hospitalization

• D dimers

  during hospitalization

Study Arms (2)

Group A

EXPERIMENTAL

Standard Anti-Covid-19 Therapy + Oral Administration of Bovine Lactoferrin 400mg (two capsules of Mosiac 200 product) every 12 h (i.e., fixed dose 800 mg / day) for 30 days and still away from meals

Dietary Supplement: Bovine lactoferrin

Group B

PLACEBO COMPARATOR

Standard anti-Covid-19 therapy + Placebo administration (capsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use.

Dietary Supplement: Placebo administration

Interventions

Bovine lactoferrin DIETARY_SUPPLEMENT

Oral Administration of Bovine Lactoferrin -fixed dose 800 mg / day for 30 days

Also known as: MOSIAC

Group A

Placebo administration DIETARY_SUPPLEMENT

capsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use.

Group B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization in non-ICU ward for Covid-19 infection, with virological diagnosis SARS-CoV2 confirmed via RT-PCR (or quick test)
• Age\>18 aa
• Covid symptomatology story from no more than 12 days

You may not qualify if:

• Refusal of consent
• Need for immediate admission to intensive care
• Severe neoplasms (in advanced stage)
• Allergies or intolerances known to Lactoferrin
• \. Already being treated with Lactoferrin at the entrance to the Hospital 5. Patients with end-stage renal failure (stage 5) 6. Extremely serious general conditions to suggest an imminent exitus 7. Clinical conditions of absolute impossibility of tolerating ingestion of drugs/capsules due to conditions contraining the initiation of therapy for os.

Sponsors & Collaborators

• Paolo Manzoni: lead

Study Sites (2)

ASL BI Ospedale degli Infermi

Ponderano, Biella, 13875, Italy

RECRUITING

AOU Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (5)

• Andersen JH, Jenssen H, Sandvik K, Gutteberg TJ. Anti-HSV activity of lactoferrin and lactoferricin is dependent on the presence of heparan sulphate at the cell surface. J Med Virol. 2004 Oct;74(2):262-71. doi: 10.1002/jmv.20171.

  PMID: 15332275 BACKGROUND

• Avula A, Nalleballe K, Narula N, Sapozhnikov S, Dandu V, Toom S, Glaser A, Elsayegh D. COVID-19 presenting as stroke. Brain Behav Immun. 2020 Jul;87:115-119. doi: 10.1016/j.bbi.2020.04.077. Epub 2020 Apr 28.

  PMID: 32360439 BACKGROUND

• Yang Z, Jiang R, Chen Q, Wang J, Duan Y, Pang X, Jiang S, Bi Y, Zhang H, Lonnerdal B, Lai J, Yin S. Concentration of Lactoferrin in Human Milk and Its Variation during Lactation in Different Chinese Populations. Nutrients. 2018 Sep 5;10(9):1235. doi: 10.3390/nu10091235.

  PMID: 30189612 BACKGROUND

• Wang Y, Wang P, Wang H, Luo Y, Wan L, Jiang M, Chu Y. Lactoferrin for the treatment of COVID-19 (Review). Exp Ther Med. 2020 Dec;20(6):272. doi: 10.3892/etm.2020.9402. Epub 2020 Oct 27.

  PMID: 33199997 BACKGROUND

• Wakabayashi H, Oda H, Yamauchi K, Abe F. Lactoferrin for prevention of common viral infections. J Infect Chemother. 2014 Nov;20(11):666-71. doi: 10.1016/j.jiac.2014.08.003. Epub 2014 Aug 30.

  PMID: 25182867 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

coat protein, papaya mosiac virus

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paolo Manzoni, MD

  ASL BI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Manzoni, MD

CONTACT

00390151515; paolomanzoni@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients are blind as Placebo administration consists of capsule identical with the same amount as an inert compound, starch of corn powder, and dispensed according to the same pattern of use. Care provider and investigator are blind as they do not know the capsule content (blisters are labelled: group 'A' or group 'B')
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective randomized double-blind placebo- controlled designed trial

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: January 14, 2021
• Primary Completion: January 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)