Effect of High Dose Intravenous Vitamin C in Severe Pneumonia

NCT05842382 | Recruiting Phase 2 DMC

• 1 other identifier: VICSEP
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 3

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.

Conditions

Pneumonia

Keywords

Severe pneumonia; Critically ill; Ascorbic acid; Vitamin C; Mechanical ventilation; Ventilation-free day

Outcome Measures

Primary Outcomes (1)

• Ventilation-free days (VFD) at 28-days

  Unit of measurement: Ventilation-free days

  First 28 days after start of randomization

Secondary Outcomes (9)

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

  First 28 days after start of randomization

• Sequential Organ Failure Assessment (SOFA) score

  Baseline, Day 4, Post intervention

• Plasma C-reactive protein (CRP) level

  Baseline, Day 4, Post intervention

• 28-day vasopressor-free days

  First 28 days after start of randomization

• 28-day intensive care unit-free days

  First 28 days after start of randomization

Study Arms (2)

IV Vitamin C (12g/day)

EXPERIMENTAL

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).

Drug: Active Ingredient

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Active Ingredient DRUG

IV Vitamin C (12g/day)

IV Vitamin C (12g/day)

Placebo DRUG

IV dextrose 5%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are aged 18 and above
• Patients who are diagnosed with severe pneumonia
• Patients who are mechanically ventilated

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• Ain Medicare Sdn Bhd: collaborator

Study Sites (3)

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

RECRUITING

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15200, Malaysia

RECRUITING

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

RECRUITING

MeSH Terms

Conditions

Pneumonia; Critical Illness

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Calvin Wong Ke Wen, MBBS MRCP

  Hospital Umum Sarawak, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Wong Ke Wen, MBBS MRCP

CONTACT

+6082276 666; vicsep.my@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: January 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)