COVID-19 Pneumonia, Vitamin C
Conditions
Keywords
Vitamin C, COVID-19
Brief summary
The main aim is to determine whether vitamin C can reduce 28-day all-cause mortality or persistent organ dysfunction compared with placebo in patients with severe and critical ill COVID-19 patients. Participants will randomly receive HIVC or placebo for 4 days once enrolled. The primary outcome is a composite of death or persistent organ dysfunction (defined as dependency on vasopressors, mechanical ventilation, or CRRT) at day 28 after randomization.
Interventions
DRUGVitamin C
The total dosage of vitamin C for the treatment group is 24 g per day.
DRUGPlacebo
The total dosage of placebo(5% glucose) for the control group is 24 g per day.
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (age 18 years or older). 2. Diagnosed with COVID-19 according to the Diagnosis and Clinical Management of COVID-19. (trial version 10). 3. severe and critical ill patients with COVID-19. 4. Patients who voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
1. Patients with a history of allergy to VC. 2. Pregnant or lactating women. 3. Patients with end-stage malignant tumour. 4. Patients with an expected survival duration of less than 24 hours. 5. Patients with cerebral hernia and severe craniocerebral injury. 6. Patients with diabetes. 7. Patients with a previous history of G-6-PD deficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 28-day mortality or persistent organ dysfunctionat day 28. | 28 days. | Persistent organ dysfunction was defined as dependency on vasopressors, mechanical ventilation, or new and persisting RRT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score. | 4 days. | The SOFA score range from 0 (mild) to 24 (critical ill). Change = (Day 4 score - Baseline score) |
| Change in Plasma Inflammatory Biomarker Concentrations. | 4 days. | — |
| Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases. | 4 days. | — |
| The duration of ventilation and vasopressor use. | 28 days. | — |
| The length of ICU stay and hospital stay. | 28 days. | — |
Countries
China
Contacts
Primary ContactLiu Zhanguo, MD,PhD
Backup ContactYu Shuang, MD
Outcome results
None listed