Clinical Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients (CEMVISCC): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 608
- Locations
- 4
- Primary Endpoint
- The 28-day mortality or persistent organ dysfunctionat day 28.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (age 18 years or older).
- •Diagnosed with COVID-19 according to the Diagnosis and Clinical Management of COVID-
- •(trial version 10).
- •severe and critical ill patients with COVID-
- •Patients who voluntarily participate in the study and sign the informed consent form.
Exclusion Criteria
- •Patients with a history of allergy to VC.
- •Pregnant or lactating women.
- •Patients with end-stage malignant tumour.
- •Patients with an expected survival duration of less than 24 hours.
- •Patients with cerebral hernia and severe craniocerebral injury.
- •Patients with diabetes.
- •Patients with a previous history of G-6-PD deficiency.
Arms & Interventions
Vitamin C
12 g Vitamin C will be infused within 6 hours by an infusion pump. This treatment will be repeated every 12 hours for 4 days.
Intervention: Vitamin C (Drug)
Placebo
The control group is assigned a placebo (5% glucose).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The 28-day mortality or persistent organ dysfunctionat day 28.
Time Frame: 28 days.
Persistent organ dysfunction was defined as dependency on vasopressors, mechanical ventilation, or new and persisting RRT.
Secondary Outcomes
- The length of ICU stay and hospital stay.(28 days.)
- Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.(4 days.)
- 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.)
Investigators
Liu Zhanguo
Clinical Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients (CEMVISCC): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Zhujiang Hospital