Status:
COMPLETED
Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborating Sponsors:
McGuire Research Institute
Conditions:
COVID-19
Hypoxia
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief 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 n...
Detailed Description
The purpose of this study is to assess the safety, tolerability, potential efficacy of high dose intravenous vitamin C (HDIVC) therapy for patients with COVID-19 and decreased oxygenation. COVID-19 is...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04357782
Start Date
April 16 2020
End Date
October 13 2020
Last Update
February 25 2022
Active Locations (1)
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1
Hunter Holmes Mcguire Veteran Affairs Medical Center
Richmond, Virginia, United States, 23249