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

Phase 2

Recruiting

• Conditions: Vitamin C; COVID-19 Pneumonia
• Interventions: Drug: Vitamin C; Drug: Placebo

• Registration Number: NCT05694975
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-13
• Study First Submitted: 2023-01-14
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-04
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 608

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C	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	Placebo	The control group is assigned a placebo (5% glucose).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The length of ICU stay and hospital stay.	28 days.
Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.	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.	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.

Trial Locations

Locations (4)

Yunfu People's Hospital; 🇨🇳 Yunfu, Guangdong, China

Department of Critical Care Medicine of Zhongshan People's Hospital; 🇨🇳 Zhongshan, Guangzhou, China

Department of Critical Care Medicine of Zhujiang Hospital; 🇨🇳 Guanzhou, Guangdong, China

the Affiliated Nanhua Hospital; 🇨🇳 Hengyang, Hunan, China