Effect of High Dose Intravenous Vitamin C in Severe Pneumonia

NCT ID: NCT05842382

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2026-02-28

Brief 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.

Detailed 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.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV Vitamin C (12g/day)

IV Vitamin C 3g diluted with dextrose 5% into 50ml, given every 6 hourly (12g/day), infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses).

Group Type: EXPERIMENTAL

Active Ingredient

Intervention Type: DRUG

IV Vitamin C (12g/day)

Placebo

IV dextrose 5% 50ml, given every 6 hourly, infused over 30 minutes under close monitoring, until successful extubation (minimum 16 doses, maximum 40 doses).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV dextrose 5%

Interventions

Active Ingredient

IV Vitamin C (12g/day)

Intervention Type: DRUG

Placebo

IV dextrose 5%

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Medicare Sdn Bhd

UNKNOWN

Sponsor Role: collaborator

Clinical Research Centre, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calvin Wong Ke Wen, MBBS MRCP

Role: PRINCIPAL_INVESTIGATOR

Hospital Umum Sarawak, Malaysia

Locations

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Site Status: RECRUITING

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Site Status: RECRUITING

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Calvin Wong Ke Wen, MBBS MRCP

Role: CONTACT

vicsep.my@gmail.com

+6082276 666

Facility Contacts

Asmah Zainudin

Role: primary

+6047406233

Wan Nasrudin Wan Ismail

Role: primary

+6097452000

Cheah Pike Kuan

Role: primary

+6052085000

Other Identifiers

VICSEP

Identifier Type: -

Identifier Source: org_study_id