Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation

• Status: Completed
• Trial end date: 2020-10-13
• Target enrollment: 0
• Participant gender: All

Summary

Previous research has shown that high dose intravenous vitamin C (HDIVC) may benefit patients with sepsis, acute lung injury (ALI), and the acute respiratory distress syndrome (ARDS). However, it is not known if early administration of HDIVC could prevent progression to ARDS.

We hypothesize that HDIVC is safe and tolerable in Coronavirus disease 2019 (COVID-19) subjects given early or late in the disease course and may reduce the risk of respiratory failure requiring mechanical ventilation and development of ARDS along with reductions in supplemental oxygen demand and inflammatory markers.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Collaborator: McGuire Research Institute
• Treatments: Ascorbic Acid

Criteria

Inclusion Criteria:

• Hospitalized with diagnosis of COVID-19 based on positive reverse transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 of nasal, oropharyngeal, or bronchoalveolar (BAL) specimen

• Mild deoxygenation defined as S/F ratio decreased by 25% from baseline on admission, or SpO2 <95% breathing ambient air on admission

• Non-childbearing potential or childbearing potential with a negative pregnancy test at screening, and using a reliable method of contraception (i.e., abstinence, hormonal contraception, intrauterine device (IUD), or vasectomized partner)

Exclusion Criteria:

• Known allergy to Vitamin C

• Inability to obtain consent from patient or next of kin

• Chronic kidney disease, stage IV or above (eGFR <30)

• Presence of diabetic ketoacidosis, use of insulin infusion, or frequent need for point-of-care glucose monitoring (>6 times/24 hour period) as determined by treating physician

• History of glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Active or history of kidney stone within past 12 months

• Pregnancy

• Enrolled in another COVID-19 clinical trial that does not allow concomitant study drugs