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.
Drug: L-ascorbic acid
50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
Other Name: Vitamin C, Intravenous
Other: Placebo
Dextrose 5% Water
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.
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 (see page 28).
- 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
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States