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Lactoferrin in Covid-19 Hospitalized Patients

NCT04847791 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2021-04-19

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Bovine lactoferrin

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

DIETARY_SUPPLEMENT

Placebo administration

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

Sponsors & Collaborators

  • Paolo Manzoni

    lead OTHER

Principal Investigators

  • Paolo Manzoni, MD · ASL BI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2022-01-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847791 on ClinicalTrials.gov