Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05842382

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are aged 18 and above
  • Patients who are diagnosed with severe pneumonia
  • Patients who are mechanically ventilated
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here