SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury … (NCT04344184) | Clinical Trial Compass
CompletedPhase 2
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
United States47 participantsStarted 2020-12-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 3.
* 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, b…
What they're measuring
1
Change in COVID Disease Status
Timeframe: Over 27 days from baseline, day 60 and day 90 day