Back to resultsEfficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients.
Primary Purpose
Vitamin C, COVID-19 Pneumonia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin C focused on measuring Vitamin C, COVID-19
Eligibility Criteria
Inclusion Criteria: Adults (age 18 years or older). Diagnosed with COVID-19 according to the Diagnosis and Clinical Management of COVID-19. (trial version 10). severe and critical ill patients with COVID-19. 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.
Sites / Locations
- Department of Critical Care Medicine of Zhujiang HospitalRecruiting
- Yunfu People's HospitalRecruiting
- Department of Critical Care Medicine of Zhongshan People's Hospital
- the Affiliated Nanhua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin C
Placebo
Arm Description
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.
The control group is assigned a placebo (5% glucose).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Change in Plasma Inflammatory Biomarker Concentrations.
Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.
The duration of ventilation and vasopressor use.
The length of ICU stay and hospital stay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05694975
Brief Title
Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients.
Official Title
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
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C, COVID-19 Pneumonia
Keywords
Vitamin C, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
608 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group is assigned a placebo (5% glucose).
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
The total dosage of vitamin C for the treatment group is 24 g per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The total dosage of placebo(5% glucose) for the control group is 24 g per day.
Primary Outcome Measure Information:
Title
The 28-day mortality or persistent organ dysfunctionat day 28.
Description
Persistent organ dysfunction was defined as dependency on vasopressors, mechanical ventilation, or new and persisting RRT.
Time Frame
28 days.
Secondary Outcome Measure Information:
Title
Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.
Description
The SOFA score range from 0 (mild) to 24 (critical ill). Change = (Day 4 score - Baseline score)
Time Frame
4 days.
Title
Change in Plasma Inflammatory Biomarker Concentrations.
Time Frame
4 days.
Title
Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.
Time Frame
4 days.
Title
The duration of ventilation and vasopressor use.
Time Frame
28 days.
Title
The length of ICU stay and hospital stay.
Time Frame
28 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (age 18 years or older).
Diagnosed with COVID-19 according to the Diagnosis and Clinical Management of COVID-19. (trial version 10).
severe and critical ill patients with COVID-19.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Zhanguo, MD,PhD
Phone
18520711669
Email
zhguoliu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Shuang, MD
Phone
13476932240
Email
yushuang7991@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Zhanguo, MD,PhD
Organizational Affiliation
Southern Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Critical Care Medicine of Zhujiang Hospital
City
Guanzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhanguo Liu, M.D.PhD
Phone
+862062782927
Email
zhguoliu@163.com
Facility Name
Yunfu People's Hospital
City
Yunfu
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Shaowu, MD
Phone
13322946821
Email
13322946821@189.cn
First Name & Middle Initial & Last Name & Degree
Peng Wei, MD
Email
1561015010@qq.com
Facility Name
Department of Critical Care Medicine of Zhongshan People's Hospital
City
Zhongshan
State/Province
Guangzhou
ZIP/Postal Code
528403
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwei Li, MD
Email
likenwei@163.com
Facility Name
the Affiliated Nanhua Hospital
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Hongyi, MD
Phone
18773486373
Email
32425082@qq.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients.
We'll reach out to this number within 24 hrs