Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients.

Overview

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.

Full Title of Study: “Clinical Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients (CEMVISCC): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2023

Interventions

  • Drug: Vitamin C
    • The total dosage of vitamin C for the treatment group is 24 g per day.
  • Drug: Placebo
    • The total dosage of placebo(5% glucose) for the control group is 24 g per day.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: Placebo
    • The control group is assigned a placebo (5% glucose).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.
    • Time Frame: 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.
    • Time Frame: 4 days.
  • Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.
    • Time Frame: 4 days.
  • The duration of ventilation and vasopressor use.
    • Time Frame: 28 days.
  • The length of ICU stay and hospital stay.
    • Time Frame: 28 days.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhujiang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: 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
  • Overall Official(s)
    • Liu Zhanguo, MD,PhD, Study Chair, Southern Medical University, China
  • Overall Contact(s)
    • Liu Zhanguo, MD,PhD, 18520711669, zhguoliu@163.com

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