NCT04344184

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• COVID-19
• Lung Injury, Acute
• Kidney Injury

Interventions

Type	Name	Description
DRUG	L-ascorbic acid	50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
OTHER	Placebo	Dextrose 5% Water

Timeline

• Start date: 2020-12-18
• Primary completion: 2022-06-10
• Completion: 2022-06-10
• First posted: 2020-04-14
• Last updated: 2024-04-04
• Results posted: 2024-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study