VItamin C in Thermal injuRY: The VICToRY Trial A phase III multi-center randomized trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Queen's University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Disorders of Environmental Origin [C21]

Trial duration

22 Nov 2022 → 20 Mar 2026

Decision date (initial)

2023-07-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Lotte & John Hecht Memorial Foundation · German research Foundation (DFG) by a grant to CS (STO 1099/10-1)

External identifiers

EU CT number

2023-504772-21-00

EudraCT number

2020-000147-31

ClinicalTrials.gov

NCT04138394

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Dose response, Efficacy, Pharmacokinetic

In patients with severe, life-threatening burn injury, what is the effect of high dose (50 mg/kg every 6 h hrs for 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC?

Secondary objectives 1

1. In patients with severe, life-threatening burn injury, what is the effect of high dose (50 mg/kg every 6 hrs for 96 hours) intravenous vitamin C in addition to SOC on time to discharge alive from hospital, hospital mortality, duration of stay in intensive care unit (ICU) and hospital, and 6-month mortality, health-related quality of life, and health care resources compared to add-on placebo and SOC?

Conditions and MedDRA coding

Severely burned patients

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 18 years of age or older with deep 2nd and/or 3rd degree burns, who are assessed as requiring skin grafting, and a minimum burn size ≥ 20% Total Body Surface Area (TBSA). Patients with smaller burns are less likely to require fluid resuscitation and their risk of morbidity and mortality is lower. Burn size will be determined by the attending physician (and confirmed by the attending surgeon if it is not the same person).

Exclusion criteria 9

1. >24 hrs from admission to participating hospital to consent.
2. Patients admitted to burn unit >24 from injury or accident.
3. Patients who are moribund (not expected to survive the next 72 hours).
4. Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
5. Enrolment in another industry sponsored intensive care unit (ICU) intervention study.
6. Receiving high-dose intravenous (IV) vitamin C already (enteral or oral vitamin C is allowed).
7. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
8. Recent history of kidney stones (within the last year).
9. Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Persistent organ dysfunction (PODS)+death at 28 days, a novel composite endpoint that combines being alive and being free of organ support (inotropes or vasopressors, renal replacement therapy and mechanical ventilation).

Secondary endpoints 2

1. • The most important secondary endpoint of this trial will be “time to discharge alive from hospital“.
2. • The other secondary outcomes will be the components of 28-day POD which include mortality, use of inotropes or vasopressors or mechanical circulatory assistance, renal replacement therapy and mechanical ventilation and POD-free days in the first 28 days.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Queen's University

Sponsor organisation

Queen's University

Address

99 University Avenue

City

Kingston

Postcode

K7L 3N5

Country

Canada

Scientific contact point

Organisation

Queen's University At Kingston

Contact name

co-ordinating investigator

Public contact point

Organisation

Queen's University At Kingston

Contact name

co-ordinating investigator

Third parties 2

Locations

5 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications