The Intensive Care Platform Trial (INCEPT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Health Care [N] - Health Care Quality, Access, and Evaluation [N05]

Trial duration

26 Jun 2025 → ongoing

Decision date (initial)

2025-02-18

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sygeforsikringen ’danmark’ · Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond · Danmarks Frie Forskningsfond · The Novo Nordisk Foundation · Dagmar Marshalls Fond · Savværksejer Jeppe Juhl og hustru Ovita Juhls Mindelegat

External identifiers

EU CT number

2024-516208-41-00

WHO UTN

U1111-1313-8171

ClinicalTrials.gov

NCT06667999

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The Intensive Care Platform Trial (INCEPT) will assess the effects of interventions used in adults acutely admitted to the intensive care unit.
INCEPT will primarily focus on interventions in common use where practice differs among clinicians, but other interventions may similarly be assessed on the platform.

Conditions and MedDRA coding

Acute critical illness requiring intensive care unit admission.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult patient (≥18 years old) acutely admitted to the ICU.
2. Eligible for at least one active domain.

Exclusion criteria 2

1. Informed consent following inclusion expected to be unobtainable (e.g., known previous objections to participation).
2. Patient is under coercive measures (e.g., ongoing involuntary hospital stay or under the jurisdiction of correctional authorities).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol).

Secondary endpoints 12

1. All-cause 30-day mortality
2. All-cause 90-day mortality
3. All-cause 180-day mortality
4. Days alive without life support at day 30
5. Days alive without life support at day 90
6. Days alive out of hospital at day 30
7. Days alive out of hospital at day 90
8. Days free of delirium at day 30
9. EQ-5D-5L index values (health-related quality of life) at day 180
10. EQ VAS (health-related quality of life) at day 180
11. Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”])
12. One or more domain-specific safety outcomes

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Anders Perner

Public contact point

Organisation

Rigshospitalet

Contact name

Rikke Larsen

Third parties 1

Locations

5 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 110 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