Effect of High Dose Intravenous Vitamin C in Severe Pneumonia

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Research Centre, Malaysia
• Collaborator: Ain Medicare Sdn Bhd

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