Status:
COMPLETED
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
Lead Sponsor:
Virginia Commonwealth University
Conditions:
COVID-19
Lung Injury, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed 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 manifestin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04344184
Start Date
December 18 2020
End Date
June 10 2022
Last Update
April 4 2024
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298