Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in the ordinal scale
研究概览
简要总结
Given its anti-viral, anti-oxidative, immune-enhancing, cytokine-modulating, and anticoagulant properties, the investigators hypothesize that Selenium infusion at supranutritional doses for moderately-ill, severely-ill, and critically-ill COVID-19 patients will prevent further clinical deterioration thus decreasing overall mortality and improving survival. To test this hypothesis, a prospective, single-center, phase II trial is proposed to assess the efficacy of Selenium in hospitalized adult patients with moderate, severe, and critical COVID-19 infections.
详细描述
COVID-19 is a respiratory illness that is caused by the novel SARS-CoV-2. Illness severity can widely range from mild, moderate, severe featuring pneumonia, to critical. Despite ongoing extensive research to find a cure for COVID-19, there had been no proven, efficacious, and widely-available treatment for the disease. With the death toll rising in various parts of the US and the world, it is imperative that investigators work on determining new therapeutic modalities. This study relates to inpatient and critical care for COVID-19 patients.
The role of Selenium (Se) as a trace element involved in many biological processes and reactions is well established in various organisms. Particularly, Selenium is known to have anti-viral, anti-oxidative, cytokine-modulating, immune-enhancing, and anticoagulant properties that might be beneficial in COVID-19 infections given the pathophysiological processes involved in the disease. Multiple preclinical and clinical studies have shed the light on the various effects exerted by Selenium in multiple inflammatory conditions including acute lung injury and acute respiratory distress syndrome, as well as viral infections including HIV and Influenza. The study team aims to explore the possible role of Selenium in mitigating the inflammatory processes involved in COVID-19 infections and hence its effect on disease progression and mortality.
Patients with COVID-19 who exhibit the signs and symptoms of moderate or severe infection or are critically ill will receive Selenium infusion for 14 days. The working hypothesis of this trial is that selenium treatment would decrease the death rates and increase the rate of hospital discharges among hospitalized patients.
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
- Double (Participant, Investigator)
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
- •Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18) prior to performing study procedure.
- •Aged ≥ 18 years.
- •Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization.
- •Currently hospitalized.
- •Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen on screening.
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-
- •Evidence of multiorgan failure.
- •Mechanically ventilated for > 5 days.
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN).
- •Creatinine clearance < 50 mL/min.
研究组 & 干预措施
Selenious Acid + Standard Of Care (SOC)
Participants who are moderately-ill, severely-ill, or critically ill will receive a Selenious Acid infusion of 2000µg on day 1 as a loading dose infusion, followed by a continuous infusion of Selenious Acid at a maintenance dose of 1000µg daily on days 2-14 together with continued Standard Of Care therapy.
干预措施: Selenium (as Selenious Acid) (Drug)
Standard Of Care (SOC) + Placebo
Participants will receive a Saline-based placebo infusion of 2000µg on day 1 as a loading dose, followed by continuous infusion of a Saline-based placebo at a maintenance dose of 1000µg daily on days 2-14. Standard Of Care is to be determined according to patients' clinical picture and may include Dexamethasone, Azithromycin, Ceftriaxone, Remdesivir, Convalescent Plasma.
干预措施: Placebo (Other)
结局指标
主要结局
Mean change in the ordinal scale
时间窗: Day 1 through Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Rate of hospital discharges or deaths
时间窗: Study duration
Rate of patient discharge to home or other long-term care facilities, or death.
次要结局
- Change from baseline in aspartate transaminase (AST)(Day 1 through Day 29)
- Change from baseline in creatinine (Cr)(Day 1 through Day 29)
- Change from baseline in glucose(Day 1 through Day 29)
- Change from baseline in hemoglobin(Day 1 through Day 29)
- Change from baseline in platelets(Day 1 through Day 29)
- Change from baseline in prothrombin time(Day 1 through Day 29)
- Change from baseline in total bilirubin(Day 1 through Day 29)
- Change from baseline in white blood cell count (WBC) with differential(Day 1 through Day 29)
- Change from baseline in interleukin-1 (IL-1)(Day 1 through Day 29)
- Change from baseline in interleukin-6 (IL-6)(Day 1 through Day 29)
- Change from baseline in tumor necrosis factor alpha (TNF-α)(Day 1 through Day 29)
- Change in National Early Warning Score (NEWS) from baseline(Day 1 through Day 29)
- Clinical status using ordinal scale(Day 1 through Day 29)
- Mean change in the ordinal scale(Day 1 though Day 29)
- Time to an improvement of one category using an ordinal scale(Day 1 though Day 29)
- Cumulative incidence of serious adverse events (SAEs)(Day 1 through Day 29)
- Duration of hospitalization(Day 1 though Day 29)
- Incidence of new oxygen use(Day 1 though Day 29)
- Duration of new oxygen use(Day 1 though Day 29)
- Incidence of new non-invasive ventilation or high flow oxygen use(Day 1 though Day 29)
- Duration of new non-invasive ventilation or high flow oxygen use(Day 1 though Day 29)
- Incidence of new ventilator use(Day 1 though Day 29)
- Duration of new ventilator use(Day 1 though Day 29)
- Discontinuation or temporary suspension of investigational therapeutics(Day 1 through Day 14)
- Change from baseline in alanine transaminase (ALT)(Day 1 through Day 29)
研究者
Mohamed Ghoweba, MD
Internal Medicine Resident Physician
CHRISTUS Health