Lactoferrin for Treatment of Acute COVID-19 Infection in Hospitalized Patients: a Double-blind Multicenter Placebo-controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- intensive care unit hospitalization rate
研究概览
简要总结
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.
详细描述
It has been shown with 'in vitro' studies that LF is able to prevent the entry of SARS-CoV-2 into the of the host cells.
Overall, the available evidence suggests that LF may be a therapeutic option that can be used to counteract and reduce the severity of Covid 19 infection. The study hase been designed in order to demonstrate efficacy of Lactoferrin in vivo.
Patients who will be admitted by Participating Centers for Covid-19 Infection will be screened for eligibility for study . If considered eligible, they will be offered participation in the Study, and it will be proposed and informed consent will be explained. Eligible patients will be registered in a centralized database at the IT systems of the University of Piedmont Orientale (UPO)/Hospital-University Company "Maggiore della Carità" of Novara. The pseudo-anonymized patient data will be recorded by the clinical centre in an 'ad hoc' Clinical Report Form with web-based access.
After obtaining informed consent, patients will then be randomised to LF or placebo group allocation using previous randomization lists Prepared. Randomization will take place on a competitive and balanced basis per clinical center participant. Permuted block randomization of size 4 will be implemented with an allocation ratio of 1:1 to ensure the balance between the groups of treatment. The randomization list will be managed through a REDCap randomization module.
The Hospital Pharmacy of the Participating Center, not involved in the enlistment of patients, will prepare a numbered sequence of sealed envelopes containing the code of allocation, and will keep its list that will remain inaccessible to the professionals involved in recruitment.These sealed envelopes will be opened sequentially, at the time of randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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')
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization in non-ICU ward for Covid-19 infection, with virological diagnosis SARS-CoV2 confirmed via RT-PCR (or quick test)
- •Covid symptomatology story from no more than 12 days
排除标准
- •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
- •Patients with end-stage renal failure (stage 5)
- •Extremely serious general conditions to suggest an imminent exitus
- •Clinical conditions of absolute impossibility of tolerating ingestion of drugs/capsules due to conditions contraining the initiation of therapy for os.
研究组 & 干预措施
Group B
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.
干预措施: Placebo administration (Dietary Supplement)
Group A
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
干预措施: Bovine lactoferrin (Dietary Supplement)
结局指标
主要结局
intensive care unit hospitalization rate
时间窗: 1 year
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
death
时间窗: 1 year
number of deaths during hospitalization
proportion of discharged patients
时间窗: 1 year
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
National Early Warning Score (NEWS)
时间窗: during hospitalization
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
次要结局
- ferritin(during hospitalization)
- IL 6(during hospitalization)
- daily clinical severity score(during hospitalization)
- oxygen(during hospitalization)
- D dimers(during hospitalization)
- hepcidine(during hospitalization)
- ventilation(during hospitalization)
- adverse events(during hospitalization)
- pO2/FiO2(during hospitalization)
研究者
Paolo Manzoni Study Group
MD
Paolo Manzoni