Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
immune hyperactivation in COVID-19 patients and/or acute respiratory distress syndrome
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519799-25-00
- EudraCT number
- 2021-003240-25
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
immune hyperactivation in COVID-19 patients and/or acute respiratory distress syndrome
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
- Address
- Calle Del Doctor Esquerdo 46
- City
- Madrid
- Postcode
- 28007
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
- Contact name
- Maria del Carmen de la Cruz Arguedas
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
- Contact name
- Maria del Carmen de la Cruz Arguedas
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Spain | Acceptable 2025-01-30
|
2025-01-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-15 | Spain | Acceptable | 2026-04-21 |