Covid19 Clinical Trial
— LACOfficial title:
Lactoferrin for Treatment of Acute COVID-19 Infection in Hospitalized Patients: a Double-blind Multicenter Placebo-controlled Randomized Trial
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.
Status | Recruiting |
Enrollment | 194 |
Est. completion date | December 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Hospitalization in non-ICU ward for Covid-19 infection, with virological diagnosis SARS-CoV2 confirmed via RT-PCR (or quick test) 2. Age>18 aa 3. Covid symptomatology story from no more than 12 days Exclusion Criteria: 1. Refusal of consent 2. Need for immediate admission to intensive care 3. Severe neoplasms (in advanced stage) 4. Allergies or intolerances known to Lactoferrin 4. 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. |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Ospedale Maggiore della Carità | Novara | |
Italy | ASL BI Ospedale degli Infermi | Ponderano | Biella |
Lead Sponsor | Collaborator |
---|---|
Paolo Manzoni |
Italy,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Yang Z, Jiang R, Chen Q, Wang J, Duan Y, Pang X, Jiang S, Bi Y, Zhang H, Lönnerdal 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). pii: E1235. doi: 10.3390/nu10091235. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | death | number of deaths during hospitalization | 1 year | |
Primary | 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 | |
Primary | 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 | daily clinical severity score | Secondary Endpoints will be the assessment of a possible superiority of the experimental treatment compared to the standard treatment with regard to improving of the daily clinical severity score detected from the day of hospitalization to that of discharge and considering all the oucome hereafter listed | during hospitalization | |
Secondary | oxygen | the assessment of a possible superiority of the experimental treatment will be evaluated considering the need for additional oxygen (yes/no), and number of days of use | during hospitalization | |
Secondary | ferritin | lab values of ferritin | during hospitalization | |
Secondary | IL 6 | lab values of IL6 | during hospitalization | |
Secondary | D dimers | lab vaules of D-dimers | during hospitalization | |
Secondary | hepcidine | lab vaules of hepcidine | during hospitalization | |
Secondary | ventilation | number of mechanical ventilation days (i.e., SIMV; SIPPV; HFOV etc) and/or CMO and number of days of ventilation in HFNC or CPAP | during hospitalization | |
Secondary | adverse events | registration of adverse events | during hospitalization | |
Secondary | pO2/FiO2 | it is expected achieving a value of pO2/FiO2 > 350 in two consecutive determinations, limited to the subgroup of patients in which this ratio was <300 at the entrance and in presence of radiologically and clinically documented pneumonia | during hospitalization |
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