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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitamin C, COVID-19 Pneumonia

Intervention / Treatment
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* Drug: Vitamin C
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, COVID-19