SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in COVID Disease Status
研究概览
简要总结
This study will evaluate the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19.
详细描述
The intravenous vitamin C treatment protocol will be comprised of four intravenous infusions a day, that is 50 mg/kg every 6 hours in patients with laboratory-confirmed SARS-CoV-2 infection manifesting COVID-19 (Novel Coronavirus Disease 2019) with hypoxemia. Treatment protocol will continue for 4 days (96 hours), and, if needed, the last study-specific bloodwork with being collected on day 7. All subjects will be followed to day 28 (phase I) and day 90 (phase II) for collection of clinical outcomes data through electronic health records (EHR) even though the treatment protocol will be completed by 96 hours from randomization at the latest. Secondary outcome data will also be collected either during in-person (clinic) visit or via telephone at the 60 and 90-day follow-up.
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
- •Adults of 18 years or older
- •Patients hospitalized with a diagnosis of COVID-19 based on central laboratory-confirmed COVID-19 Novel Coronavirus Disease-2019, based on a positive SARS-CoV-2 RT-PCR confirmed within 72 hours prior to enrollment of nasal, oropharyngeal, or BAL specimen with hypoxemia, (i.e., decrease in oxygenation, as outlined below)
- •Pulse oximetry saturation (SpO2) < 93% on room air in WHO COVID-19 ordinal scale 3 patients, regardless the need for assisted ventilation, or oxygenation.
- •Any new requirement of supplemental oxygen, with any oxygen device (WHO COVID-19 ordinal scale 4-7, regardless of pulse oximetry reading)
- •In patients with supplemental oxygen at home, any increase in the requirement of supplemental oxygen.
- •In ICU level care
排除标准
- •Age less than 18 years
- •Known allergy to Vitamin C
- •Inability to obtain consent from patient or next of kin
- •Presence of diabetic ketoacidosis
- •ANY history of oxalate stones at any time
- •Patients with Kidney Disease Improving Global Outcomes (KDIGO), CKD stage 4 (eGFR < 30 ml/min, CKD stage 5 and end-stage renal disease on dialysis patients are excluded.
- •Patients with Acute Kidney Injury, stage
- •Pregnant, or lactating
- •Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Patients who received the following medications within 7 days prior to enrollment, or plan to receive during enrollment, or 7 days after enrollment: aluminum hydroxide, bortezomib, copper, deferoxamine, amphetamines including derivatives such as fluphenazine.
- •Patients with active sickle cell crisis
- •Prisoners
- •Patients outside ICU level care
研究组 & 干预措施
Infusion
L-Ascorbic Acid (Vitamin C), intravenous infusion
干预措施: L-ascorbic acid (Drug)
Placebo
Dextrose 5% Water
干预措施: Placebo (Other)
结局指标
主要结局
Change in COVID Disease Status
时间窗: Over 27 days from baseline, day 60 and day 90 day
COVID disease status was measured for improvement using the World Health Organization (WHO) ordinal scale for clinical improvement of COVID-19 over ICU admission within 27 days. The WHO scale is a 9-point ordinal scale ranging from uninfected (0), ambulatory (1-2), hospitalized with severe disease (5), hospitalized with intubation and organ support (6-7) and death (score of 8).
次要结局
- Number of Patients Alive and Free of Respiratory Failure(At 28-days)
- Change in Serum Lactate Dehydrogenase (LDH) Levels(Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7)
- Renal Safety Biomarkers - Urine Oxalate Stones(On days 5,7 and 14)
- Acute Kidney Injury-free Days(Over 27 days from baseline)
- Number of Deaths(Over 27 days from baseline, day 60 and day 90 day)
- Renal Safety Biomarkers - Serum Oxalate(On days 5,7 and 14)
- Change in Plasma IL-6 Levels(Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7)
- Number of Patients Alive and Free of Invasive Mechanical Ventilation(At 28-days)
- Renal Safety Biomarkers - 24-hour Urine Oxalate Levels(On days 5,7 and 14)
- Change in Plasma Ferritin Levels(Day 0 (baseline), day 1, day 7)
- Change in Plasma D-dimer Levels(Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7)