NCT05451654终止1 期
A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
Medesis Pharma SA1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年2月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change of the PaO2/FiO2 ratio
研究概览
简要总结
This is a prospective, multicenter, randomized (3:1), placebo- controlled, parallel-group, double-blind trial.
Patients will be randomized into two arms of treatment:
- Placebo + SoC (N=30)
- NanoManganese® + SoC (N=90)
Patients will be treated and followed-up for 10 days:
- Arterial oxygen partial pressure (PaO2) will be measured at baseline and at days 3, 5 and 10,
- Oxygen saturation, vital signs including respiration rate, pulse rate, blood pressure and body temperature, disease severity (7-point ordinal scale and NEWS2 score) will be measured at baseline and daily,
- Hematology and biochemistry measurements will be done at baseline and at day 3, 5 and 10,
- Pharmacokinetic (Blood Mn concentration) measurements will be done at baseline and at day 3, 5 and 10,
- Biomarkers will be measured at baseline and at day 3, 5 and 10. At the end of the 10-day treatment period, a follow-up visit will be planned between day 15 and day 22. The following.
assessments/examinations will be performed: oxygen saturation, vital signs including respiration rate and body temperature, disease severity (7-point ordinal scale and NEWS2 score), electrocardiogram (ECG), hematology, biochemistry, concomitant therapies, and adverse events.
详细描述
120 patients will be enrolled in this study, they will be randomly assigned in 2 arms on a 3:1 ratio, 90 patients in the NanoManganese®
- Standard of Care group and 30 patients in the placebo + Standard of Care group.
This study will be conducted in Brazil and will be conducted in around 8 investigational sites
The investigational products are :
Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology. The product is mucoadhesive, it sticks to the mucosa of the cheeks on which it will be deposited and will not be swallowed.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patient aged ≥ 18 years
- •Patient hospitalized with positive COVID-19, confirmed by a Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or an antigen test done ≤ 7 days before study entry
- •Patient with at least 1 of the National Institutes of Health COVID- 19 clinical symptoms (Fever or chills, Cough, Shortness of breath or difficulty breathing, Fatigue, Muscle or body aches, Headache, New loss of taste or smell, Sore throat, Congestion or runny nose, Nausea or vomiting, Diarrhea) that appeared ≤ 15 days before study entry
- •Patient with a peripheral capillary oxygen saturation (SpO2) < 96%, or with an arterial oxygen partial pressure (PaO2) ≤65 mmHg, at study entry
- •Female patient of childbearing potential must be willing to use an efficient birth control method during the study and until 3 months after IMP administration.
- •A woman is considered to be of childbearing potential if she is post menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus, tubal ligation). The following are acceptable contraceptive methods: - Established use of oral, injected, or implanted hormonal methods of contraception - Intrauterine system or placement of an intrauterine device - Double barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository - True abstinence [periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception]
- •Male patient must be willing to use male contraception (condom) during the study, avoid donating semen during study and until 3 months after last dose of IMP administration.
- •Patient must sign the informed consent form
- •Patient who have or have not been vaccinated for COVID-19 (1, 2, 3 or 4 shots) can enter the study
排除标准
- •Refusal to participate expressed by patient
- •Pregnancy or breast-feeding
- •Anticipated transfer to another hospital, which is not a study site within 72 hours
- •Contraindication to Manganese supplementation
- •Patient under Long-term oxygen therapy or invasive ventilation prior to COVID-19 infection
- •Patient requiring Continuous Positive Airway Pressure (CPAP), high flow, or Non-Invasive Ventilation (NIV) and a SpO2 <92%
- •Patient on invasive mechanical ventilation
- •Patient with homozygotic sickle cell disease or methemoglobin.
- •Patient receiving a biotherapy as a SoC for COVID-19
- •Patient participating in another drug trial
- •Patient under guardianship or prisoner
- •Patient with a written order for restricted care
- •Patient allergic to peanut or soja
- •Patient under parenteral nutrition (with Mn in composition)
研究组 & 干预措施
Placebo + SoC (N=30)
Placebo Comparator
This arm is composed by 30 patients.
- Placebo: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
- Standard of care
干预措施: Placebo (Drug)
NanoManganese® + SoC (N=90)
Experimental
This arm is composed by 90 patients.
NanoManganese® + standard of care group:
- NanoManganese®: administration of 2 mL twice a day (morning and evening) by depositing 1 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
- Standard of care
干预措施: Experimental drug (Drug)
结局指标
主要结局
Change of the PaO2/FiO2 ratio
时间窗: 10 days
Change from baseline to D10 of the PaO2/FiO2 ratio in the NanoManganese® + SoC group and in the placebo+ SoC group.
次要结局
- Evolution of respiratory rate over time(10 days)
- Change of PaO2(10 days)
- Proportion of patients with PaO2 > 65 mmHg(10 days)
- Oxygen free days at D15-22 after inclusion(10 days)
- Proportion of patients with SpO2 ≥ 95%(10 days)
- Change of SpO2(10 days)
- Incidence of oxygen use(10 days)
- Duration of oxygen use(10 days)
- Incidence of noninvasive support (high flow, CPAP, NIV) use(10 days)
- Duration of noninvasive support (high flow, CPAP, NIV) use(10 days)
- Noninvasive support (high flow, CPAP, NIV) free days during follow- up (between D15 and D22 after inclusion(10 days)
- Incidence of invasive mechanical ventilation use,(10 days)
- Duration of invasive mechanical ventilation use(10 days)
- Invasive mechanical ventilation free days during follow-up (between D15 and D22 after inclusion)(10 days)
- Overall survival at day 22 and cause of death(10 days)
- Time to improvement of 1 level on seven point ordinal scale(10 days)
- Clinical status assessed by ordinal scale(10 days)
- Description of ICU-free days during follow-up (between D15 and D22 after inclusion)(10 days)
- Proportion of patient transferred in ICU(10 days)
研究者
研究点 (1)
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