Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
418
Countries
1
Sites
1
Post COVID-19 Syndrome
Improvement in memory satisfaction from baseline to week 8 when comparing methyl-prednisolone with placebo in PCS patients
Key facts
- Sponsor
- Charite Universitaetsmedizin Berlin KöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 2 Jul 2024 → 25 Mar 2025
- Decision date (initial)
- 2023-06-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504826-21-00
- WHO UTN
- U1111-1290-2592
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
Improvement in memory satisfaction from baseline to week 8 when comparing methyl-prednisolone with placebo in PCS patients
Secondary objectives 5
- Long-term improvement in memory satisfaction from baseline to week 20 and to week 52
- Improvement in memory ability, and memory strategy
- Improvement in neurocognitive symptoms quantified using neuropsychological and cognitive scores
- Improvement in quality of life
- Improvement in fatigue and mood
Conditions and MedDRA coding
Post COVID-19 Syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- History of confirmed (PCR or serology or rapid antigen detection and sick note or comparable certificate after Dec 21, 2023) SARS-CoV-2 infection according to WHO criteria
- Ongoing symptoms of PCS for ≥ 3 months
- Self-reported cognitive deficits at screening
Exclusion criteria 5
- Any ongoing central nervous system disease
- Any major psychiatric disease within the last 10 years
- Previous medical history of gastric ulcer, osteoporosis and/or previous vertebral fractures, rheumatological disease or metabolic disease including diabetes mellitus
- Ongoing immunosuppressive therapy
- Patient is pregnant or breastfeeding at screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- to show an intra-patient change in MMQ, subdomain memory satisfaction by ≥15 points from baseline to week 8
Secondary endpoints 5
- Intra-patient change in MMQ subdomain memory satisfaction from baseline to week 20, from week 8 to week 20 and from week 20 to week 52
- Mean difference in MMQ subdomain ‘memory ability’ from baseline to week 8 and to week 20 and from week 8 to week 20 Mean difference in MMQ subdomain ‘memory strategy’ to week 8 and to week 20 and from week 8 to week 20
- Intra-patient change in neuro-psychological and cognitive scores (MoCA, neuropsychological test battery, SDMT) from baseline to week 8 and to week 20 and from week 8 to week 20
- Intra-patient change in quantified PROMIS questionnaire and SF-36 from baseline to week 8 and to week 20 and to week 52 and from week 8 to week 20
- Intra-patient change in fatigue scores (FSS, Chandler Fatigue Scale) and mood (BDI) from baseline to week 8
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Methylprednisolon 16 mg JENAPHARM®
PRD2528771 · Product
- Active substance
- Methylprednisolone
- Substance synonyms
- 6-METHYLPREDNISOLONE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 104 mg milligram(s)
- Max total dose
- 528 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- 32484.02.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification of the authorised test product Methylprednisolone 16 JENAPHARM® consists of relabelling of the Immadiate packaging and repackaging in a modified secondary packaging. The individual tablets remain in the original blister pack.
Placebo 1
P-Tabletten weiß 7 mm Lichtenstein
PRD6671968 · Product
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 104 mg milligram(s)
- Max total dose
- 264 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- NOTASSIGN — -
- Marketing authorisation
- 6866372.00.00
- MA holder
- WINTHROP ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification of the authorised product P-Tabletten weiß 7 mm Lichtenstein consists of relabelling of the Immadiate packaging and repackaging in a modified secondary packaging. The individual tablets remain in the original blister pack.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Charite Universitaetsmedizin Berlin KöR
- Sponsor organisation
- Charite Universitaetsmedizin Berlin KöR
- Address
- Hindenburgdamm 30, Lichterfelde Lichterfelde
- City
- Berlin
- Postcode
- 12203
- Country
- Germany
Scientific contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Christiana Franke
Public contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Prof. Heinrich Audebert
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| CellTrend GmbH ORG-100023729
|
Luckenwalde, Germany | Laboratory analysis |
| Charite Universitaetsmedizin Berlin KöR ORG-100008480
|
Berlin, Germany | On site monitoring, Code 10, Code 12, Code 5, Data management, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 418 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Germany | 2023-09-13 | 2023-09-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-22811
- Halt date
- 2024-04-24
- Planned restart
- 2024-05-26
- Member states concerned
- Germany
- Publication date
- 2024-04-24
- Reason
- Sponsor decision, Medicinal Product related
- Explanation
- Please refer to serious breach and attached documents:
In summary: accidental unblinding of 4 patients due to removal of blister
foil along with label:
All affected patients were in the verum arm of the study.
Due to this issue, the Clinical Trial Office (CTO) and Quality Assurance (QA) Unit of the
Charité were notified, initiating an investigation into a possible “Serious Breach”
according to Clinical Trials Regulation (CTR).
QA Unit (represented by Ms. Pilger) examined returned study medication at the study
site on 09.04.2024, identifying a systemic error in verum labeling, confirming a Serious
Breach. - Follow-up measures
- IMP manufacturer will address the manufacturing defect, IMP modification will be documented in study documents, provided as substantial amendment to CTIS, all unblinded patients will be excluded from data analysis
- Benefit-risk balance changed
- No
- Treatment stopped
- No
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 |
|---|---|---|---|
| Summary of results_EU CT 2023-504826-21-00 SUM-124609
|
2026-03-23T09:52:21 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results_DE_EU CT 2023-504826-21-00 | 2026-03-23T09:53:55 | Submitted | Laypersons Summary of Results |
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Person Summary of Results_DE_EU CT 2023-504826-21-00_geschwarzt | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AdvertisingText_GER_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patients_adults_redacted | 6.0 |
| Summary of results (for publication) | Summary of results_EU CT 2023-504826-21-00_redacted | 1.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-31 | Germany | Acceptable 2023-06-19
|
2023-06-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-07 | Germany | Acceptable 2023-08-31
|
2023-09-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-22 | Germany | Acceptable 2024-01-16
|
2024-01-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-27 | Germany | Acceptable 2024-04-22
|
2024-04-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-06 | Germany | Acceptable 2024-06-21
|
2024-06-21 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-13 | Germany | Acceptable 2024-06-21
|
2024-11-13 |