SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2

Conditions: COVID-19; Kidney Injury; Lung Injury, Acute

Treatments: Drug: L-ascorbic acid; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04344184

HM20018977

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, bortezomib, copper, deferoxamine, amphetamines including derivatives such as fluphenazine.
• Patients with active sickle cell crisis
• Prisoners
• Patients outside ICU level care

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups, including a placebo group

Infusion

Active Comparator group

Description:

L-Ascorbic Acid (Vitamin C), intravenous infusion

Treatment:

Drug: L-ascorbic acid

Placebo

Placebo Comparator group

Description:

Dextrose 5% Water

Treatment:

Other: Placebo