Early Corticosteroids in Severe Influenza Pneumonia, a phase III randomized controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospital Region Metz Thionville

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-06-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To compare the efficacy of dexamethasone versus placebo in patients with severe influenza on a hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days between day 0 and day 28.

Secondary objectives 9

1. comparison between the two study groups of in-hospital death at day 28
2. comparison between the two study groups of organ dysfunction at day 28
3. comparison between the two study groups of days alive without life support at day 28
4. comparison between the two study groups of the duration of supplemental oxygen, non-invasive ventilation, high flow oxygen at day 28
5. comparison between the two study groups of the length of stay in hospital and ICU
6. comparison between the two study groups of viral clearance
7. comparison between the two study groups of quality of life at day 90
8. comparison between the two study groups of 90-day mortality
9. comparison between the two study groups of safety endpoint: occurrence of adverse events between day 0 and day 28

Conditions and MedDRA coding

patients with influenza-induced acute hypoxemic respiratory failure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥ 18 years
2. Admission to ICU or intermediate care for less than 2 days
3. Admission to hospital for less than 5 days
4. Diagnosis of influenza pneumonia with • PCR positive for Influenza dated less than 5 days • AND focal shadowing/infiltrates on chest X-ray or CT-scan • AND at least one of the following: cough, purulent sputum, chest pain or dyspnoea
5. Requirement of supplemental oxygen at a flow rate of at least 3 L/min OR non-invasive ventilation OR high flow oxygen therapy OR invasive mechanical ventilation.
6. Written informed or emergency consent
7. Ongoing medical insurance

Exclusion criteria 15

1. Moribund state
2. Bone marrow transplant or chemotherapy-induced neutropenia
3. Known allergy to dexamethasone or to one of its excipients
4. Uncontrolled psychotic states
5. Pheochromocytoma
6. Co-infection with COVID-19
7. Cardiogenic shock secondary to influenza myocarditis
8. Known active tuberculosis or fungal infection
9. Active viral hepatitis or active herpes virus infection
10. Patient at risk of strongyloidiasis
11. Subject with shock on enrolment and on ongoing vasopressor therapy (≥ 0.25 microg/kg/min)
12. Indication for corticosteroid therapy in a dosage above 0.5 mg/kg/day prednisone-equivalent
13. Subject deprived of liberty or under a legal protective measure (example: patients under guardianship or curatorship)
14. Pregnant or breastfeeding woman
15. Lack of clinical equipoise by the attending physician and/or the presence of a substantial risk associated with the patients’ participation in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Hierarchical composite endpoint, scored as follows: 1. In-hospital death (all-cause) at day 28 (yes/no), 2. If alive at day 28, number of ventilator-free days between day 0 and day 28, 3. If mechanical ventilation never required, number of ICU-free days between day 0 and day 28. Each patient in the intervention group will be compared with each patient in the control group according to this score: a win, loss, or tie will be defined for each pair based on which scored better.

Secondary endpoints 9

1. In-hospital death (all-cause) at day 28
2. Occurrence of organ dysfunction: need for extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation (MV), renal replacement therapy (RRT) and vasopressors
3. Number of days alive without life support (ECMO, MV, RRT and vasopressor) at day 28
4. Duration of supplemental oxygen use, non-invasive ventilation, high flow oxygen at day 28
5. Length of stay in hospital and ICU
6. Nasopharyngeal viral load measured at subsequent time-points (baseline, day 4, day 8)
7. SF-36 quality of life questionnaire at day 90
8. 90-day mortality
9. Safety endpoint: occurrence of adverse events between D0 and D28: a. Hyperglycaemia (i.e., need for new insulin or increase in insulin >30% from initial/baseline dose); b. Clinically significant gastrointestinal bleeding (requiring endoscopy or red blood cell transfusion); c. Occurrence of Influenza-associated pulmonary aspergillosis ; d. Occurrence of ventilatory-acquired pneumonia ; e. New episodes of septic shock according to the Sepsis-3 criteria

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospital Region Metz Thionville

Sponsor organisation

Centre Hospital Region Metz Thionville

Address

1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Ars Laquenexy Cs 45001 Ars Laquenexy Ars Laquenexy

City

Metz Cedex 03

Postcode

57085

Country

France

Scientific contact point

Organisation

Centre Hospital Region Metz Thionville

Contact name

LOUIS Guillaume

Public contact point

Organisation

Centre Hospital Region Metz Thionville

Contact name

LOUIS Guillaume

Locations

1 EU/EEA country · 48 investigational sites

By country

Investigational sites

Results and documents

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

Documents 17 files

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

Application history

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