Actively Recruiting
Effect of High Dose Intravenous Vitamin C in Severe Pneumonia
Led by Clinical Research Centre, Malaysia · Updated on 2024-06-20
484
Participants Needed
3
Research Sites
107 weeks
Total Duration
On this page
Sponsors
C
Clinical Research Centre, Malaysia
Lead Sponsor
A
Ain Medicare Sdn Bhd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of High Dose Intravenous Vitamin C in Severe Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are aged 18 and above
- Patients who are diagnosed with severe pneumonia
- Patients who are mechanically ventilated
You will not qualify if you...
- 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 4100 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia, 05460
Actively Recruiting
2
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia, 15200
Actively Recruiting
3
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia, 30450
Actively Recruiting
Research Team
C
Calvin Wong Ke Wen, MBBS MRCP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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