High dose intravenous Vitamin C for severe pneumonia treatment
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 study is testing if high doses of intravenous Vitamin C can help patients with severe pneumonia who are on ventilators get better faster than standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Research Centre, Malaysia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Alor Star, Kedah and 2 other locations) |
| Trial ID | NCT05842382 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of high dose intravenous Vitamin C as an adjunct therapy for patients with severe pneumonia who are mechanically ventilated. It is a multicenter, randomized, double-blind, placebo-controlled trial where participants will receive either 12g/day of Vitamin C or a placebo every six hours until successful extubation. The study aims to assess the efficacy and safety of this treatment approach compared to standard care. Data will be collected electronically, and follow-up will occur at day 60 post-randomization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above diagnosed with severe pneumonia who are currently on mechanical ventilation.
Not a fit: Patients with known allergies to Vitamin C, those who are pregnant, or those with certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients with severe pneumonia requiring mechanical ventilation.
How similar studies have performed: While the use of Vitamin C in critical care settings has been explored, this specific high-dose intravenous approach in severe pneumonia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are aged 18 and above * Patients who are diagnosed with severe pneumonia * Patients who are mechanically ventilated Exclusion Criteria: * 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 * 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
Where this trial is running
Alor Star, Kedah and 2 other locations
- Hospital Sultanah Bahiyah — Alor Star, Kedah, Malaysia (Recruiting)
- Hospital Raja Perempuan Zainab II — Kota Bharu, Kelantan, Malaysia (Recruiting)
- Hospital Raja Permaisuri Bainun — Ipoh, Perak, Malaysia (Recruiting)
Study contacts
- Principal investigator: Calvin Wong Ke Wen, MBBS MRCP — Hospital Umum Sarawak, Malaysia
- Study coordinator: Calvin Wong Ke Wen, MBBS MRCP
- Email: vicsep.my@gmail.com
- Phone: +6082276 666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.