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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
Dextrose 5% Water
Virginia Commonwealth University
Richmond, Virginia, United States
Change in COVID Disease Status
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).
Time frame: Over 27 days from baseline, day 60 and day 90 day
Renal Safety Biomarkers - Serum Oxalate
Change in serum oxalate levels
Time frame: On days 5,7 and 14
Renal Safety Biomarkers - Urine Oxalate Stones
Microscopic analysis of urine for presence of oxalate stones
Time frame: On days 5,7 and 14
Renal Safety Biomarkers - 24-hour Urine Oxalate Levels
Renal safety will be Measured via renal safety biomarkers - 24- hour urine oxalate level
Time frame: On days 5,7 and 14
Acute Kidney Injury-free Days
Renal-failure free days, with AKI defined by the KDIGO criteria
Time frame: Over 27 days from baseline
Number of Deaths
Mortality by all cause was comprehensively collected using hospital encounter information over 27 days from baseline, in addition to public record review at day 60 and day 90. Results for this outcome represents the number of deaths that have occurred between each time point.
Time frame: Over 27 days from baseline, day 60 and day 90 day
Change in Plasma Ferritin Levels
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Difference in plasma ferritin levels in ng/mL, compared to baseline levels
Time frame: Day 0 (baseline), day 1, day 7
Change in Plasma D-dimer Levels
Difference in D-dimer levels in mcg/mL, compared to baseline levels
Time frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6, and 7
Change in Serum Lactate Dehydrogenase (LDH) Levels
Difference in lactate dehydrogenase (LDH) levels in units/L, compared to baseline levels
Time frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Change in Plasma IL-6 Levels
Difference in plasma IL-6 levels in pg/mL, compared to baseline levels
Time frame: Day 0 (baseline), days 1, 2, 3, 4, 5, 6 and 7
Number of Patients Alive and Free of Respiratory Failure
Respiratory failure defined as resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation
Time frame: At 28-days
Number of Patients Alive and Free of Invasive Mechanical Ventilation
Number of patients alive and not requiring invasive mechanical ventilation. The results represent the number of patients who were ventilator free.
Time frame: At 28-days