Clinical trial • Phase III • Infectious Disease|Respiratory

SODIUM ASCORBATE for Sepsis|Acute respiratory distress syndrome

Phase III trial of SODIUM ASCORBATE for Sepsis|Acute respiratory distress syndrome.

Overview

Trial Therapeutic Area
Infectious Disease|Respiratory
Trial Disease
Sepsis|Acute respiratory distress syndrome
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
05-11-2024

Trial design

Randomised, active: biological therapies sodium ascorbate solution 30 g in 100 ml injection (sodium ascorbate) — intravenous injection; dosing fields indicate up to 200 mg/kg per day with max total 800 mg/kg and max treatment period 4 (time unit as provided). comparator/placebo: sodium chloride (placebo) — intravenous infusion; dosing fields indicate up to 200 ml per day with max total 800 ml and max treatment period 4 (time unit as provided).-controlled Phase III trial across 16 sites in France.

Randomised
Yes
Comparator
Active: Biological Therapies Sodium Ascorbate Solution 30 g in 100 mL Injection (SODIUM ASCORBATE) — intravenous injection; dosing fields indicate up to 200 mg/kg per day with max total 800 mg/kg and max treatment period 4 (time unit as provided). Comparator/placebo: SODIUM CHLORIDE (placebo) — intravenous infusion; dosing fields indicate up to 200 ml per day with max total 800 ml and max treatment period 4 (time unit as provided).
Target Sample Size
814
Trial Duration For Participant
28

Eligibility

Recruits 814 The protocol allows inclusion of patients under guardianship or curatorship. Consent: "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". Specific subject information and informed consent forms are provided for adults, adults under curatorship, adults under guardianship, close relation consent, and continued participation, indicating procedures for consent/representative consent in vulnerable adults..

Pregnancy Exclusion
Pregnancy and breast-feeding
Vulnerable Population
The protocol allows inclusion of patients under guardianship or curatorship. Consent: "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". Specific subject information and informed consent forms are provided for adults, adults under curatorship, adults under guardianship, close relation consent, and continued participation, indicating procedures for consent/representative consent in vulnerable adults.

Inclusion criteria

  • {"criterion_text":"- Patients ≥ 18 years old\n- Admitted to the ICU with proven or suspected infection as the main diagnosis\n- Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine, angiotensin, others))\n- Currently treated with high flow oxygen, CPAP OR NIV OR Invasive Ventilation\n- 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\n- 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\n- Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU)\n- Patients under guardianship or curatorship can be included\n- Patients in case of simple emergency (legal definition) or vital emergency will be included"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- Death or persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) at 28 days","definition_or_measurement_approach":"Assessed at 28 days; persistent organ dysfunction defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors."}

Recruitment

Planned Sample Size
814
Recruitment Window Months
84
Consent Approach
Informed written consent is required from the patient when they are capable. If the patient is not capable, the patient's representative signs consent whenever present at inclusion ("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"). The study includes specific subject information and informed consent forms for adults, adults under curatorship, adults under guardianship, close relations, and continued participation, indicating tailored consent procedures for vulnerable adults.

Geography

Total Number Of Sites
16
Total Number Of Participants
814

France

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
392
Number Of Sites
16
Number Of Participants
814

Sites

Site Name
Centre Hospitalier Sud Essonne-Dourdan-Etampes
Department Name
Multipurpose intensive care
Contact Person Name
Shidasp SIAMI
Contact Person Email
Shidasp.Siami@ch-sudessonne.fr
Site Name
Centre Hospitalier De Dieppe
Department Name
Intensive Care
Contact Person Name
Jean-Philippe RIGAUD
Contact Person Email
Apetain@ch-dieppe.fr
Site Name
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Department Name
Multipurpose intensive care
Contact Person Name
Arnaud SEMENT
Contact Person Email
arnaud.sement@ch-mdm.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Intensive Care
Contact Person Name
François BARBIER
Site Name
Assistance Publique Hopitaux De Paris (site)
Department Name
Intensive Care
Contact Person Name
Alain COMBES
Contact Person Email
alain.combes@psl.aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Intensive Care
Contact Person Name
Jean REIGNIER
Contact Person Email
jean.reignier@chu-nantes.fr
Site Name
Hospices Civils De Lyon
Department Name
Intensive care
Contact Person Name
Laurent ARGAUD
Contact Person Email
laurent.argaud@chu-lyon.fr
Site Name
Centre Hospitalier De Dax Cote D'Argent
Department Name
Multipurpose intensive care
Contact Person Name
Adrien AUVET
Contact Person Email
auveta@ch-dax.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Multipurpose intensive care unit
Contact Person Name
Armand MEKONTSO DESSAP
Contact Person Email
armand.dessap@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Intensive Care
Contact Person Name
Carole SCHWEBEL
Contact Person Email
cschwebel@chu-grenoble.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris Cedex 18)
Department Name
Medical and infectious intensive care
Contact Person Name
Jean-François TIMSIT
Contact Person Email
jean-francois.timsit@aphp.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Multipurpose intensive care
Contact Person Name
Bruno FRANCOIS
Contact Person Email
bruno.francois@chu-limoges.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris Cedex 10)
Department Name
Medical and Toxicological Intensive Care
Contact Person Name
Bruno MEGARBANE
Contact Person Email
bruno.megarbane@aphp.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Multipurpose intensive care
Contact Person Name
Gwenhaël COLIN
Contact Person Email
gwenhael.colin@chd-vendee.fr
Site Name
Assistance Publique Hopitaux De Paris (Garches)
Department Name
Medical-surgical intensive care unit
Contact Person Name
Nicholas HEMING
Contact Person Email
nicholas.heming@aphp.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Intensive Care
Contact Person Name
Jean-Pierre QUENOT

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Biological Therapies Sodium Ascorbate Solution 30 g in 100 mL Injection
Active Substance
SODIUM ASCORBATE
Modality
Small molecule
Routes Of Administration
Intravenous injection
Route
Intravenous injection
Authorisation Status
MIA N° 2023_200_1_2_3_10 (EPHP-AGEPS)
Frequency
Daily (up to 4 days) as per dosing fields
Maximum Dose
200 mg/kg per day (max total 800 mg/kg)
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
No marketing authorisation number (marketingAuthNumber '-') ; scientificProductEvCode SUB12581MIG
Frequency
Daily (up to 4 days) as per dosing fields
Maximum Dose
200 ml per day (max total 800 ml)

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