Vitamin CPhase 2/3NCT05694975
Efficacy of Megadose Vitamin C in Severe and Critical Ill COVID-19 Patients.
A Phase 2/3 study testing Vitamin C in people with Vitamin C and COVID-19 Pneumonia, run by Zhujiang Hospital at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin C, COVID-19 Pneumonia
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 608 participants
- Where
- 4 sitesChina
- Study dates
- 13 Jan 2023to Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Department of Critical Care Medicine of Zhujiang Hospital
Guanzhou, Guangdong
zhanguo Liu, M.D.PhD, +862062782927, zhguoliu@163.com
- Recruiting
the Affiliated Nanhua Hospital
Hengyang, Hunan
Yao Hongyi, MD, 18773486373, 32425082@qq.com
- Recruiting
Yunfu People's Hospital
Yunfu, Guangdong
Chen Shaowu, MD, 13322946821, 13322946821@189.cn
Peng Wei, MD, 1561015010@qq.com
- Not yet recruiting
Department of Critical Care Medicine of Zhongshan People's Hospital
Zhongshan, Guangzhou, 528403
Jianwei Li, MD, likenwei@163.com
About this study
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
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.
- Conditions
- Vitamin C, COVID-19 Pneumonia
- Being tested
- Vitamin C, Placebo
- Keywords
- Vitamin C, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
The total dosage of vitamin C for the treatment group is 24 g per day.
PlaceboDrug
The total dosage of placebo(5% glucose) for the control group is 24 g per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin C |
| Placebo | Placebo comparator | The control group is assigned a placebo (5% glucose). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days.
Secondary outcomes (5)
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)
Measured: 4 days.
Change in Plasma Inflammatory Biomarker Concentrations.
Measured: 4 days.
Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.
Measured: 4 days.
The duration of ventilation and vasopressor use.
Measured: 28 days.
The length of ICU stay and hospital stay.
Measured: 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start13 Jan 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin CStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Liu Zhanguo, MD,PhD, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694975
- Sponsor's protocol ID
- 2023-KY-001-02
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05694975
- Acronym / sponsor ID
- 2023-KY-001-02
- Conditions
- Vitamin C, COVID-19 Pneumonia
- Keywords
- Vitamin C, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 13 Jan 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin C12 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 comparator | Drug: PlaceboThe control group is assigned a placebo (5% glucose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CThe total dosage of vitamin C for the treatment group is 24 g per day. | Drug | Vitamin C |
| PlaceboThe total dosage of placebo(5% glucose) for the control group is 24 g per day. | Drug | Placebo |
Primary outcome
The 28-day mortality or persistent organ dysfunctionat day 28.
Time frame: 28 days.
Persistent organ dysfunction was defined as dependency on vasopressors, mechanical ventilation, or new and persisting RRT.
5 secondary outcomes
Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score.
Time frame: 4 days.
Change in Plasma Inflammatory Biomarker Concentrations.
Time frame: 4 days.
Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases.
Time frame: 4 days.
The duration of ventilation and vasopressor use.
Time frame: 28 days.
The length of ICU stay and hospital stay.
Time frame: 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Zhanguo, MD,PhD study chair
Southern Medical University, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin C in people with Vitamin C and COVID-19 Pneumonia, run by Zhujiang Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Zhanguo, MD,PhD (18520711669, zhguoliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 28-day mortality or persistent organ dysfunctionat day 28. (time frame: 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.