Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
9
Countries
2
Sites
6
Covid19 Corona Virus Infection
To characterize the pharmacokinetics (PK) of baricitinib* in pediatric patients with COVID-19
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 15 Nov 2021 → 4 Nov 2024
- Decision date (initial)
- 2024-09-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516824-32-00
- EudraCT number
- 2021-001338-21
- WHO UTN
- U1111-1311-8257
- ClinicalTrials.gov
- NCT05074420
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Safety
To characterize the pharmacokinetics (PK) of baricitinib* in pediatric patients with COVID-19
Conditions and MedDRA coding
Covid19 Corona Virus Infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants must be hospitalized with coronavirus (COVID-19) infection
- Participants must need oxygen therapy
Exclusion criteria 7
- Participants must not be taking biologic therapy or other drugs which suppresses the body’s immune response
- Participants must not have active tuberculosis (TB)
- Participants must not have any other serious infection (besides COVID-19)
- Participants must not need a machine to help them breathe (ventilator) at study entry
- Participants must not have Cancer
- Participants must not have a history of a blood clot
- Participants must not be pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
- PK: Maximum Concentration (Cmax) of Baricitinib
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10162774 · Product
- Active substance
- Baricitinib
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- Yes
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 1 | 1 |
| Spain | Ended | 3 | 5 |
| Rest of world
Mexico, Brazil, United States
|
— | 5 | — |
Investigational sites
Centre Hospitalier Regional De La Citadelle
Physician, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Hospital Universitario La Paz
Pediatría y enfermedades infecciosas, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Unidad Pediátrica de Investigación y Ensayos Clínicos, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico San Carlos
Pediatrics, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Araba
Pediatria, Jose Achotegui Kalea S/N, 01009, Vitoria
Hospital Universitario De Navarra
Pediatrics, Irunlarrea Kalea 3, 31008, Pamplona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2021-11-15 | ||||
| Spain | 2021-11-15 | 2021-12-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| I4V-MC-KHAB_Final Summary of Results_2024-516824-32-00 SUM-136609
|
2026-05-29T12:45:21 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| I4V-MC-KHAB_Lay Person Summary of Results_2024-516824-32-00 | 2026-05-29T12:50:29 | Submitted | Laypersons Summary of Results |
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | I4V-MC-KHAB_Lay Person Summary of Results_2024-516824-32-00 | 1 |
| Protocol (for publication) | D1_Protocol EU CT number 2024-516824-32-00_Redacted | a |
| Recruitment arrangements (for publication) | K1_Blank document | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Adults_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Assent form older child_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Assent form younger child | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Parents_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_ICF procedure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_ICF Sponsor Statement | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Patient Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Assent Older BEDU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Assent Older BEFR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Assent Older EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Assent Younger BEDU | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Assent Younger BEFR | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Assent Younger EN | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Main BEDU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Main BEFR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Main EN_Redacted | 3.0 |
| Summary of results (for publication) | I4V-MC-KHAB_Final Summary of Results_2024-516824-32-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-17 | Belgium | Acceptable with conditions 2024-09-27
|
2024-09-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-23 | Belgium | Acceptable with conditions 2024-09-27
|
2024-12-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-15 | Belgium | Acceptable with conditions 2024-09-27
|
2025-08-15 |