Health TrialsbyHealthPanel

Effect of High Dose Intravenous Vitamin C in Severe Pneumonia

ConditionPneumonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinical Research Centre, Malaysia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are aged 18 and above

Patients who are diagnosed with severe pneumonia

Patients who are mechanically ventilated

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Ingredient

    Drug

    IV Vitamin C (12g/day)

  • Placebo

    Drug

    IV dextrose 5%

Treatment groups

484 Participants
are divided into 2 treatment groups
Group A: IV Vitamin C (12g/day)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventilation-free days (VFD) at 28-days

Unit of measurement: Ventilation-free days

Time frame
First 28 days after start of randomization

Secondary outcomes

1

Subdistribution hazard ratio of ventilation-free event with mortality as the competing event

Unit of measurement: Cumulative incidence curve, Subdistribution hazard ratio

Time frame
First 28 days after start of randomization
2

Sequential Organ Failure Assessment (SOFA) score

Unit of measurement: Point score

Time frame
Baseline, Day 4, Post intervention
3

Plasma C-reactive protein (CRP) level

Unit of measurement: mg/L

Time frame
Baseline, Day 4, Post intervention
4

28-day vasopressor-free days

Unit of measurement: Vasopressor-free day

Time frame
First 28 days after start of randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Research Centre, Malaysia

Lead sponsor

Ain Medicare Sdn Bhd

Collaborator

Source ClinicalTrials.gov
Apply now