Lessening Organ Dysfunction with VITamin C in septic ARDS

Start 5 Nov 2024 · Status Authorised, recruiting · 1 EU/EEA countries · 17 sites · Protocol APHP200019

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruiting

Participants planned 814

Countries 1

Sites 17

Patient with sepsis complicated by ARDS

To compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction – defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors – assessed at 28 days on ICU patients

Key facts

Sponsor: Assistance Publique Hopitaux De Paris
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration: 5 Nov 2024 → ongoing
Decision date (initial): 2024-11-05
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-516394-78-00
EudraCT number: 2020-003923-40
ClinicalTrials.gov: NCT04404387

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Conditions and MedDRA coding

Patient with sepsis complicated by ARDS

Version	Level	Code	Term	System organ class
21.1	PT	10001052	Acute respiratory distress syndrome	100000004855

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

Patients ≥ 18 years old
Admitted to the ICU with proven or suspected infection as the main diagnosis
Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine, angiotensin, others))
Currently treated with high flow oxygen, CPAP OR NIV OR Invasive Ventilation
Presenting with Acute Respiratory Distress Syndromedefined by all the following criteria: o Acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome o Bilateral opacities on chest imaging not explained by other pulmonary pathologies (e.g. pleural effusion, atelectasis, nodules, etc.) o No evidence for heart failure or volume overload o PaO2/FiO2 ≤ 200 mm Hg o PEEP ≥ 5 cm H2O
Patient who has signed an informed and written consent whenener he/she is capable of consent, if not, Patient’s representant signed consent whenever he/she is present at inclusion
Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)
Patients under guardianship or curatorship can be included
Patients in case of simple emergency (legal definition) or vital emergency will be included

Exclusion criteria 13

48 hours from diagnosis of ARDS
Patient with critical COVID-19 according WHO definition
Cardio-pulmonary resuscitation (CPR) in the past 72 hours
Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Pregnancy and breast-feeding
Hyperoxaluria
Known allergy excipients of vitamin C solution; or to one of the excipients in particular methyl parhydroxybenzoate (E218) or propyl (E216)
Treatment with Deferoxamine
Known kidney stones within the past 1 year
Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition (PN) in doses standard for PN
Expected death or withdrawal of life-sustaining treatments within 48 hours
Previously enrolled in this study
Previously enrolled in an interventional trial for which co-enrolment is not allowed (co-enrolment to be determined case by case)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Death or persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) at 28 days

Investigational products

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

Test 1

Biological Therapies Sodium Ascorbate Solution 30 g in 100 mL Injection

PRD12476135 · Product

Active substance: Sodium Ascorbate
Substance synonyms: SODIUM ASCORBATE E301
Pharmaceutical form: INJECTION
Route of administration: INJECTION
Max daily dose: 200 mg/kg milligram(s)/kilogram
Max total dose: 800 mg/kg milligram(s)/kilogram
Max treatment duration: 4 Day(s)
Authorisation status: Not Authorised
ATC code: A11GA01 — ASCORBIC ACID (VIT C)
MA holder: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Paediatric formulation: No
Orphan designation: No

Placebo 1

Sodium Chloride

SUB12581MIG · Substance

Active substance: Sodium Chloride
Pharmaceutical form: INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 200 ml millilitre(s)
Max total dose: 800 ml millilitre(s)
Max treatment duration: 4 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation: Assistance Publique Hopitaux De Paris
Address: Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
City: Paris Cedex 10
Postcode: 75475
Country: France

Scientific contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Coordinating investigator

Public contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Coordinating investigator

Locations

1 EU/EEA country · 17 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruiting	814	17
Rest of world	—	0	—

Investigational sites

France

17 sites · Authorised, recruiting

Centre Hospitalier Et Universitaire De Limoges

Multipurpose intensive care, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1

Centre Hospitalier Universitaire Grenoble Alpes

Intensive Care, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9

Centre Hospitalier Universitaire De Dijon

Intensive Care, 14 Rue Paul Gaffarel, 21000, Dijon

Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources

Multipurpose intensive care, Avenue Pierre De Coubertin, Bp 417, Mont-De-Marsan Cedex