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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694975
• Other study ID #: 2023-KY-001-02
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 13, 2023
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Zhujiang Hospital
• Contact: Liu Zhanguo, MD,PhD
• Phone: 18520711669
• Email: zhguoliu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Vitamin C

Intervention

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

Locations

Country	Name	City	State
China	Department of Critical Care Medicine of Zhujiang Hospital	Guanzhou	Guangdong
China	the Affiliated Nanhua Hospital	Hengyang	Hunan
China	Yunfu People's Hospital	Yunfu	Guangdong
China	Department of Critical Care Medicine of Zhongshan People's Hospital	Zhongshan	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Change in Plasma Inflammatory Biomarker Concentrations.		4 days.
Secondary	Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.		4 days.
Secondary	The duration of ventilation and vasopressor use.		28 days.
Secondary	The length of ICU stay and hospital stay.		28 days.