NCT05694975

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
608

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 14, 2023

Last Update Submit

January 19, 2023

Conditions

Vitamin CCOVID-19 Pneumonia

Keywords

Vitamin CCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes in the Sepsis-Related Organ Failure Assessment (SOFA) 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.

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

The control group is assigned a placebo (5% glucose).

Drug: Placebo

Interventions

Vitamin CDRUG

The total dosage of vitamin C for the treatment group is 24 g per day.

Vitamin C
PlaceboDRUG

The total dosage of placebo(5% glucose) for the control group is 24 g per day.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Critical Care Medicine of Zhujiang Hospital

Guanzhou, Guangdong, China

RECRUITING

Yunfu People's Hospital

Yunfu, Guangdong, China

RECRUITING

Department of Critical Care Medicine of Zhongshan People's Hospital

Zhongshan, Guangzhou, 528403, China

NOT YET RECRUITING

the Affiliated Nanhua Hospital

Hengyang, Hunan, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Liu Zhanguo, MD,PhD

    Southern Medical University, China

    STUDY CHAIR

Central Study Contacts

Liu Zhanguo, MD,PhD

CONTACT

18520711669zhguoliu@163.com

Yu Shuang, MD

CONTACT

13476932240yushuang7991@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI 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 Record Dates

First Submitted

January 14, 2023

First Posted

January 23, 2023

Study Start

January 13, 2023

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

CN(4)