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

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

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 Overview

• Status: Recruiting
• Conditions: COVID-19 Pneumonia; Vitamin C
• Intervention / Treatment: Drug: Vitamin C; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 608
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Liu Zhanguo, MD,PhD; Phone Number: 18520711669; Email: zhguoliu@163.com
• Study Contact Backup: Name: Yu Shuang, MD; Phone Number: 13476932240; Email: yushuang7991@163.com

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China
      • Recruiting
      • Department of Critical Care Medicine of Zhujiang Hospital
    • Yunfu, Guangdong, China
      • Recruiting
      • Yunfu People's Hospital
      • Contact: Chen Shaowu, MD; Phone Number: 13322946821; Email: 13322946821@189.cn
      • Contact: Peng Wei, MD; Email: 1561015010@qq.com
  • Guangzhou
    • Zhongshan, Guangzhou, China, 528403
      • Not yet recruiting
      • Department of Critical Care Medicine of Zhongshan People's Hospital
  • Hunan
    • Hengyang, Hunan, China
      • Recruiting
      • the Affiliated Nanhua Hospital
      • Contact: Yao Hongyi, MD; Phone Number: 18773486373; Email: 32425082@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Vitamin C; The total dosage of vitamin C for the treatment group is 24 g per day.
Placebo Comparator: Placebo; The control group is assigned a placebo (5% glucose).	Drug: Placebo; The total dosage of placebo(5% glucose) for the control group is 24 g per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 28-day mortality or persistent organ dysfunctionat day 28.	Persistent organ dysfunction was defined as dependency on vasopressors, mechanical ventilation, or new and persisting RRT.	28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.	The SOFA score range from 0 (mild) to 24 (critical ill). Change = (Day 4 score - Baseline 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.
The length of ICU stay and hospital stay.		28 days.

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Study Chair: Liu Zhanguo, MD,PhD, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Anticipated): January 13, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 14, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Vitamin C
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 2023-KY-001-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No