Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
150
Countries
1
Sites
1
Covid-19 infection
Evaluate the extent and persistence over time of the humoral and cellular immune response in subjects who received MAbs after SARS-CoV-2 infection and had a different vaccination status at the time of infection and evaluate the impact of different revaccination times on the humoral and cellular response
Key facts
- Sponsor
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514071-17-00
- EudraCT number
- 2022-000905-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluate the extent and persistence over time of the humoral and cellular immune
response in subjects who received MAbs after SARS-CoV-2 infection and had a different
vaccination status at the time of infection and evaluate the impact of different
revaccination times on the humoral and cellular response
Conditions and MedDRA coding
Covid-19 infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10047438 | Viral infectious disorders | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- The subjects eligible for inclusion in the study are patients diagnosed with COVID-19 who meet the access criteria established by the Ministry / AIFA / Regions Program, with the following access criteria [10] (In case of changes, the criteria inclusion will be modified accordingly): a. 18 year old patients and older with laboratory confirmed SARS-CoV-2 infection and mild or moderate COVID-19 disease onset within 7 days of evaluation who are at high risk for severe COVID-19 infection. Possible risk factors include the following: • body mass index (BMI) =30, or> 95th percentile for age and gender • chronic renal failure • uncontrolled diabetes mellitus (HbA1c> 9.0% 75 mmol / mol) or with chronic complications • primary or secondary immunodeficiency • age> 65 years • cardio-cerebrovascular disease • chronic obstructive pulmonary disease and / or other chronic respiratory disease • chronic liver disease • hemoglobinopathies • neurodevelopmental pathologies and neurodegenerative pathologies. b. Treatment is possible beyond 7 days from onset only in subjects with immunodeficiency who have: negative SARS-COV-2 serology and prolonged positivity to molecular swab
Exclusion criteria 1
- - Patients under 18 year old - Inability to sign informed consent - hospitalized for COVID-19 - Have any concomitant serious systemic disease, condition or disorder which, in the opinion of the investigator, should preclude participation in this study - known allergy or hypersensitivity to the components of the study drug - Unmanageable drug interactions to treatment drugs (Annex 4).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.
Secondary endpoints 1
- 1) Evaluate the anti-N IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 2) Evaluate the anti-S IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 3) Evaluate the titer of neutralizing antibodies at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 4) Evaluate cellular immunity to S and N with IGRA test at 0, 4, 12 months after MAbs infusion
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PRD9317052 · Product
- Active substance
- Tozinameran
- Substance synonyms
- Nucleoside-modified mRNA encoding a modified version of the SARS-CoV-2 S protein, BNT162b2, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 30 µg microgram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/003
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Spikevax 0.2 mg/mL dispersion for injection COVID-19 mRNA Vaccine
PRD8631818 · Product
- Active substance
- Elasomeran
- Substance synonyms
- mRNA-1273, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), CX-024414, COVID-19 mRNA vaccine Moderna (CX-024414)
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 100 µg microgram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1507/001
- MA holder
- MODERNA BIOTECH SPAIN S. L.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Nuvaxovid dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted)
PRD10335122 · Product
- Active substance
- SARS-COV-2, Spike Protein, Recombinant, Expressed in SF9 Cells Derived From Spodoptera Frugiperda
- Substance synonyms
- NVX-CoV2373, SARS-CoV-2 rS, TAK-019
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 5 µg microgram(s)
- Max total dose
- 5 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BX03 — -
- Marketing authorisation
- EU/1/21/1618/002
- MA holder
- NOVAVAX CZ A.S.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xevudy 500 mg concentrate for solution for infusion
PRD9372713 · 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 USE
- 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
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EVUSHELD 150 mg + 150 mg solution for injection
PRD9606398 · Product
- Active substance
- Cilgavimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 600 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
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
National Institute For Infectious Diseases Lazzaro Spallanzani
- Sponsor organisation
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Address
- Via Portuense 292
- City
- Rome
- Postcode
- 00149
- Country
- Italy
Scientific contact point
- Organisation
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Contact name
- Valentina Mazzotta
Public contact point
- Organisation
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Contact name
- Valentina Mazzotta
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ctcae_v5_quick_reference_5x7 | 5 |
| Protocol (for publication) | D1_Protocol_V2_05aug2024_FP_RenoirSM3 | 2 |
| Protocol (for publication) | D1_Protocol_V2_1_05122024_clean RenoirSM3_fp | 2.1 |
| Protocol (for publication) | D1_Protocol_V2_1_05122024_track RenoirSM3_fp | 2.1 |
| Protocol (for publication) | Protocol annex 1_Scheda di valutazione medica arruolamento_V1 20Feb2022 | 1 |
| Protocol (for publication) | Protocol annex 4_Trattamenti in studio_V1 20Feb2022 | 1 |
| Recruitment arrangements (for publication) | Recruitment_arragments | 1 |
| Subject information and informed consent form (for publication) | 5_RENOIR_Allegato 3_Modulo informativo e consenso informato_Versione 2 del 04_05_2022_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP_Letter_IT_pub V1 20Feb2022_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 11_EVUSHELD_Informativa_Paziente_Evusheld_22feb2022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 12_XEVUDY_epar-product-information_it | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 13_MODERNA_footer_005438_049283_RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 14_PFIZER_footer_005389_049269_RCP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 15_Novavax_scheda tecninca_ | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_V2_05aug2024_clean Renoir SM3 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_V2_05aug2024_clean Renoir SM3_redacted | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Italy | Acceptable 2024-07-25
|
2024-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-21 | Italy | Acceptable 2025-01-13
|
2025-01-14 |