Phase 2
N=20
Administration of Intravenous Vitamin C in Novel Coronavirus Infection (COVID-19) and Decreased Oxygenation
COVID-19 · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT04357782 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants With Adverse Events Related to High Dose Intravenous Vitamin C (HDIVC) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- L-ascorbic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Related to High Dose Intravenous Vitamin C (HDIVC) |
0; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Reactions |
0; 2 | — |
| PRIMARY Number of Participants With Adverse Reactions |
1; 2 | — |
| SECONDARY Ventilator-free Days |
28; 23.5 | — |
| SECONDARY Intensive Care Unit (ICU)-Free Days |
28; 13.5 | — |
| SECONDARY Hospital-free Days |
21.5; 8.5 | — |
| SECONDARY All-cause Mortality |
0; 3 | — |
| SECONDARY Change in S/F Ratio During High Dose Intravenous Vitamin C (HDIVC) |
108; 26 | — |
| SECONDARY C-reactive Protein (CRP) |
-3.8; -2.0 | — |
| SECONDARY Lactate Dehydrogenase (LDH) |
-42; 118 | — |
| SECONDARY D-dimer |
-0.21; 3.71 | — |
| SECONDARY Lymphocyte Count |
329; 276 | — |
| SECONDARY Neutrophil to Lymphocyte Ratio (NLR) |
-0.89; -0.04 | — |
| SECONDARY Serum Ferritin |
-299; -1170 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT04357782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.