PneumoniaPhase 2VICSEPNCT05842382
Effect of High Dose Intravenous Vitamin C in Severe Pneumonia
A Phase 2 study testing Active Ingredient in people with Pneumonia, run by Clinical Research Centre, Malaysia at 3 sites in Malaysia.
Trial summary
This trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Active Ingredient
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 3 sitesMalaysia
- Study dates
- 12 Jan 2024to Feb 2026
- Phase
- Phase 2
- 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
- Patients who are aged 18 and above
- Patients who are diagnosed with severe pneumonia
- Patients who are mechanically ventilated
Who cannot join
- Known allergy to Vitamin C
- Pregnancy
- Known history of ongoing concomitant infection
- Participation in another clinical trial and/or receipt of investigational drugs within 4 weeks prior to enrollment
- Moribund patient with multiorgan failure to the judgement of the treating physician, who is not expected to survive 24 hours
- Patient who requires home oxygen therapy or mechanical ventilation, including tracheostomy or non-invasive ventilation, except for CPAP/BIPAP for sleep-disordered breathing
Show all 21Show fewer
- Known history of previous or current diagnosis of renal stones
- Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Known diagnosis of hemochromatosis
- Known diagnosis of poorly controlled chronic pulmonary disease, including:
- Chronic obstructive pulmonary disease with oxygen therapy
- Chronic restrictive pulmonary disease with oxygen therapy
- Bronchial asthma on Step 5 of treatment ladder as shown in Pocket Guide for Asthma Management and Prevention
- Lung cancer in Stage IV of disease
- Known diagnosis of heart failure on anti-failure treatment or requiring mechanical hemodynamic support (e.g. LVAD), with recent hospitalization within 3 months (90 days) from the date of current admission.
- Immunocompromised state
- Known diagnosis of malignancy and ongoing chemotherapy or radiotherapy as there is evidence that antioxidant supplement before and during treatment was associated with an increased hazard of recurrence
- Known diagnosis of malignancy who had completed chemotherapy or radiotherapy with absolute neutrophil count ≤100 cells/mm3
- Known diagnosis of Stage 4 and above chronic kidney disease (GFR <30 ml/min/1.73m2) and end-stage renal disease on regular dialysis (including peritoneal dialysis or hemodialysis)
- Known history of renal transplantation
- Absence of family members or next of kin for informed consent
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Asmah Zainudin, +6047406233
Asmah Zainudin, MBBS MMED
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450
Cheah Pike Kuan, +6052085000
Cheah Pike Kuan, MD MMED
- Recruiting
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15200
Wan Nasrudin Wan Ismail, +6097452000
Wan Nasrudin Wan Ismail, MD MMED FCICM
About this study
Official title: Effect of High Dose Intravenous Vitamin C as an Adjunct in the Treatment of Patients With Severe Pneumonia in Intensive Care Unit: a Multi-center, Double-blinded, Two-arm, Placebo-controlled, Randomized Trial
This trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU.
Read the detailed description
Subjects will be randomized 1:1 to receive either high dose IV Vitamin C (12g/day) or placebo, every 6 hourly, until successful extubation (minimum 16 doses, maximum 40 doses). Placebo will be the equivalent volume of dextrose 5% given intravenously. Active drug or placebo will be prepared in a sterile method by designated personnel at each site. Active drug or placebo will be prepared in a 50cc syringe and infusion tubing attached, where both are coloured and UV-protected. The recruitment period is expected to be 24 months. Phone call follow-up will be conducted at day 60 (+7 days) post-randomization to review subjects' activities of daily living. All data will be entered electronically into REDCap.
All randomized subjects will be included in the intention-to-treat analysis (ITT) dataset for primary and secondary efficacy endpoints analyses. Safety analysis will be conducted for all subjects who received at least one dose of study drug. There are no interim analyses planned in this trial. At least one safety review will be conducted at 50% target recruitment.
- Conditions
- Pneumonia
- Being tested
- Active Ingredient, Placebo
- Keywords
- Severe pneumonia, Critically ill, Ascorbic acid, Vitamin C, Mechanical ventilation, Ventilation-free day
- Medical subject headings
- Pneumonia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active IngredientDrug
IV Vitamin C (12g/day)
PlaceboDrug
IV dextrose 5%
| Study group | Role | What they receive |
|---|---|---|
| IV Vitamin C (12g/day) | Experimental | IV Vitamin C 3g diluted with dextrose 5% into 50ml, given every 6 hourly (12g/day), infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses). Receives: Drug: Active Ingredient |
| Placebo | Placebo comparator | IV dextrose 5% 50ml, given every 6 hourly, infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation-free days (VFD) at 28-days
Unit of measurement: Ventilation-free days
Measured: First 28 days after start of randomization
Secondary outcomes (9)
Subdistribution hazard ratio of ventilation-free event with mortality as the competing event
Unit of measurement: Cumulative incidence curve, Subdistribution hazard ratio
Measured: First 28 days after start of randomization
Sequential Organ Failure Assessment (SOFA) score
Unit of measurement: Point score
Measured: Baseline, Day 4, Post intervention
Plasma C-reactive protein (CRP) level
Unit of measurement: mg/L
Measured: Baseline, Day 4, Post intervention
28-day vasopressor-free days
Unit of measurement: Vasopressor-free day
Measured: First 28 days after start of randomization
28-day intensive care unit-free days
Unit of measurement: ICU-free days
Measured: First 28 days after start of randomization
60-day hospitalization-free days
Unit of measurement: Hospitalization-free days
Measured: First 60 days after start of randomization
All-cause mortality rates at 28-day
Unit of measurement: Proportion, Percentage
Measured: First 28 days after start of randomization
Barthel index of activities of daily living
Unit of measurement: Point score
Measured: Baseline, Day 60
Plasma ascorbate levels
Unit of measurement: μM
Measured: Baseline, Day 2 (Between 8th and 9th dose OR Between 9th and 10th dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start12 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Medicare Sdn Bhd
- Responsible party
- Sponsor
- Investigators
- Calvin Wong Ke Wen, MBBS MRCP, Principal investigator, Hospital Umum Sarawak, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842382
- Sponsor's protocol ID
- VICSEP
- Acronym
- VICSEP
- Status last verified
- Jun 2024
- First submitted
- 24 Apr 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Dose Intravenous Vitamin C as an Adjunct in the Treatment of Patients With Severe Pneumonia in Intensive Care Unit: a Multi-center, Double-blinded, Two-arm, Placebo-controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT05842382
- Acronym / sponsor ID
- VICSEP / VICSEP
- Conditions
- Pneumonia
- Keywords
- Severe pneumonia, Critically ill, Ascorbic acid, Vitamin C, Mechanical ventilation, Ventilation-free day
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Ain Medicare Sdn Bhd
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 May 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.
This trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU.
Detailed description
Subjects will be randomized 1:1 to receive either high dose IV Vitamin C (12g/day) or placebo, every 6 hourly, until successful extubation (minimum 16 doses, maximum 40 doses). Placebo will be the equivalent volume of dextrose 5% given intravenously. Active drug or placebo will be prepared in a sterile method by designated personnel at each site. Active drug or placebo will be prepared in a 50cc syringe and infusion tubing attached, where both are coloured and UV-protected. The recruitment period is expected to be 24 months. Phone call follow-up will be conducted at day 60 (+7 days) post-randomization to review subjects' activities of daily living. All data will be entered electronically into REDCap.
All randomized subjects will be included in the intention-to-treat analysis (ITT) dataset for primary and secondary efficacy endpoints analyses. Safety analysis will be conducted for all subjects who received at least one dose of study drug. There are no interim analyses planned in this trial. At least one safety review will be conducted at 50% target recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Vitamin C (12g/day) | Experimental | Drug: Active IngredientIV Vitamin C 3g diluted with dextrose 5% into 50ml, given every 6 hourly (12g/day), infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses). |
| Placebo | Placebo comparator | Drug: PlaceboIV dextrose 5% 50ml, given every 6 hourly, infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are aged 18 and above
- Patients who are diagnosed with severe pneumonia
- Patients who are mechanically ventilated
Key exclusion criteria (21 listed)
- Known allergy to Vitamin C
- Pregnancy
- Known history of ongoing concomitant infection
- Participation in another clinical trial and/or receipt of investigational drugs within 4 weeks prior to enrollment
- Moribund patient with multiorgan failure to the judgement of the treating physician, who is not expected to survive 24 hours
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 |
|---|---|---|
| Active IngredientIV Vitamin C (12g/day) | Drug | IV Vitamin C (12g/day) |
| PlaceboIV dextrose 5% | Drug | Placebo |
Primary outcome
Ventilation-free days (VFD) at 28-days
Time frame: First 28 days after start of randomization
Unit of measurement: Ventilation-free days
9 secondary outcomes
Subdistribution hazard ratio of ventilation-free event with mortality as the competing event
Time frame: First 28 days after start of randomization
Sequential Organ Failure Assessment (SOFA) score
Time frame: Baseline, Day 4, Post intervention
Plasma C-reactive protein (CRP) level
Time frame: Baseline, Day 4, Post intervention
28-day vasopressor-free days
Time frame: First 28 days after start of randomization
28-day intensive care unit-free days
Time frame: First 28 days after start of randomization
60-day hospitalization-free days
Time frame: First 60 days after start of randomization
All-cause mortality rates at 28-day
Time frame: First 28 days after start of randomization
Barthel index of activities of daily living
Time frame: Baseline, Day 60
Plasma ascorbate levels
Time frame: Baseline, Day 2 (Between 8th and 9th dose OR Between 9th and 10th dose)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Calvin Wong Ke Wen, MBBS MRCP principal investigator
Hospital Umum Sarawak, Malaysia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Ingredient in people with Pneumonia, run by Clinical Research Centre, Malaysia at 3 sites in Malaysia.
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 3 inclusion and 21 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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 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.
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 Calvin Wong Ke Wen, MBBS MRCP (+6082276 666, vicsep.my@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation-free days (VFD) at 28-days (time frame: First 28 days after start of randomization). 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 20 Jun 2024.