Effect of High Dose Intravenous Vitamin C in Severe Pneumonia

Last updated: June 17, 2024
Sponsor: Clinical Research Centre, Malaysia
Overall Status: Active - Recruiting

Phase

2

Condition

Pneumonia

Treatment

Placebo

Active Ingredient

Clinical Study ID

NCT05842382
VICSEP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are aged 18 and above

  • Patients who are diagnosed with severe pneumonia

  • Patients who are mechanically ventilated

Exclusion

Exclusion Criteria:

  • Known allergy to Vitamin C

  • Pregnancy

  • Known history of ongoing concomitant infection

  • Participation in another clinical trial and/or receipt of investigational drugswithin 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, includingtracheostomy or non-invasive ventilation, except for CPAP/BIPAP for sleep-disorderedbreathing

  • 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 forAsthma Management and Prevention

  • Lung cancer in Stage IV of disease

  • Known diagnosis of heart failure on anti-failure treatment or requiring mechanicalhemodynamic support (e.g. LVAD), with recent hospitalization within 3 months (90days) from the date of current admission.

  • Immunocompromised state

  • Known diagnosis of malignancy and ongoing chemotherapy or radiotherapy as there isevidence that antioxidant supplement before and during treatment was associated withan increased hazard of recurrence

  • Known diagnosis of malignancy who had completed chemotherapy or radiotherapy withabsolute 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 orhemodialysis)

  • Known history of renal transplantation

  • Absence of family members or next of kin for informed consent

Study Design

Total Participants: 484
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 12, 2024
Estimated Completion Date:
February 28, 2026

Study Description

Subjects will be randomized 1:1 to receive either high dose IV Vitamin C (12g/day) or placebo, every 6 hourly, until successful extubation (minimum 16 doses, maximum 40 doses). Placebo will be the equivalent volume of dextrose 5% given intravenously. Active drug or placebo will be prepared in a sterile method by designated personnel at each site. Active drug or placebo will be prepared in a 50cc syringe and infusion tubing attached, where both are coloured and UV-protected. The recruitment period is expected to be 24 months. Phone call follow-up will be conducted at day 60 (+7 days) post-randomization to review subjects' activities of daily living. All data will be entered electronically into REDCap.

All randomized subjects will be included in the intention-to-treat analysis (ITT) dataset for primary and secondary efficacy endpoints analyses. Safety analysis will be conducted for all subjects who received at least one dose of study drug. There are no interim analyses planned in this trial. At least one safety review will be conducted at 50% target recruitment.

Connect with a study center

  • Hospital Sultanah Bahiyah

    Alor Setar, Kedah 05460
    Malaysia

    Active - Recruiting

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan 15200
    Malaysia

    Active - Recruiting

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak 30450
    Malaysia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.