Overview
Sponsor-declared trial summary
SARS-CoV-2 infection
- A. What are the SARS-CoV-2 viral load kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2 and the occurence of SARS-CoV-2 infection when used as a prophylactic? - B. Do viral variants, spike mutations and immune escape occur during treatment with n…
Key facts
- Sponsor
- Stichting Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 22 Nov 2024 → 25 May 2025
- Decision date (initial)
- 2024-11-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515263-60-00
- EudraCT number
- 2021-005051-37
- ClinicalTrials.gov
- NCT05195060
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis, Therapy
- A. What are the SARS-CoV-2 viral load kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2 and the occurence of SARS-CoV-2 infection when used as a prophylactic?
- B. Do viral variants, spike mutations and immune escape occur during treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?
- C. What are the viral antibody and inflammatory response kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?
- D. To create a biobank to address future questions regarding the current use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2 compared to novel Covid-19 treatments which are in development.
Conditions and MedDRA coding
SARS-CoV-2 infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- All patients that are treated with neutralizing SARS-CoV-2 antibodies and other antivirals against or as prevention of SARS-CoV-2 as standard of care.
- Patients have to be aged ≥ 18 y.
Exclusion criteria 2
- No informed consent is provided by the patient.
- Patients not suitable to fulfil study procedures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- What are the SARS-CoV-2 viral load kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2 and the occurence of SARS-CoV-2 infection when used as a prophylactic?
- Do viral variants, spike mutations and immune escape occur during treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?
- What are the viral antibody and inflammatory response kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2?
- To create a biobank to address future questions regarding the current use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2 compared to novel COVID-19 treatments which are in development.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Xevudy 500 mg concentrate for solution for infusion
PRD9372710 · Product
- Active substance
- Sotrovimab
- Substance synonyms
- GSK4182136, VIR-7831, Human IgG1 (438-leucine,444-serine) monoclonal antibody against SARS-CoV-2 spike protein
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BD05 — -
- Marketing authorisation
- EU/1/21/1562/001
- MA holder
- GLAXOSMITHKLINE TRADING SERVICES LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ronapreve 300 mg + 300 mg solution for injection/infusion
PRD9334736 · Product
- Active substance
- Casirivimab
- Substance synonyms
- Human IgG1 monoclonal antibody against SARS-CoV-2, spike protein, receptor binding domain, REGN10933
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 8000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BD07 — -
- Marketing authorisation
- EU/1/21/1601/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EVUSHELD 150 mg + 150 mg solution for injection
PRD9606357 · Product
- Active substance
- Cilgavimab
- Substance synonyms
- AZD1061, Human IgG1 kappa (248-threonine,249-methionine,316-tyrosine,318-threonine,320-glutamic acid) monoclonal antibody against SARS-CoV-2, spike protein, receptor binding domain
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BD03 — -
- Marketing authorisation
- EU/1/22/1651/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paxlovid 150 mg + 100 mg film-coated tablets
PRD9472501 · Product
- Active substance
- Nirmatrelvir
- Substance synonyms
- (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide, PF-07321332, (1R,2S,5S)-N-{(1S)-1-cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl}-6,6-dimethyl-3- [3-methyl-N-(trifluoroacetyl)-L-valyl]-3-azabicyclo[3.1.0]hexane-2-carboxamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 8000 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AE30 — -
- Marketing authorisation
- EU/1/22/1625/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Amsterdam UMC
- Sponsor organisation
- Stichting Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Joost W. Wiersinga
Public contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Joost W. Wiersinga
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 400 | 4 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-11-22 | 2025-05-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515263-60-00 | 5.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF control patients | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF prophylactic patients | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF treatment patients | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Evusheld | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Paxlovid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ronapreve | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sotrovimab | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Netherlands | Acceptable 2024-11-22
|
2024-11-22 |