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Clinical trials for Sotrovimab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: Sotrovimab. Displaying page 1 of 1.
    EudraCT Number: 2021-003717-18 Sponsor Protocol Number: 215226/VIR-7831-5005 Start Date*: 2021-12-30
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovim...
    Medical condition: COVID-19 at high risk of disease progression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2021-004266-35 Sponsor Protocol Number: MAICOVID-19 Start Date*: 2021-12-22
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: A phase 3, multicentre, single-blinded, randomized controlled study to compare the efficacy and safety of Casirivimab and Imdevimab or Bamlanivimab and Etesevimab or Sotrovimab in COVID-19 home pat...
    Medical condition: Mild to moderate COVID-19 patients at high risk of progression to severe COVID-19 and / or hospitalization
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000623-13 Sponsor Protocol Number: VIR-7831-5008 Start Date*: 2021-07-29
    Sponsor Name:Vir Biotechnology, Inc.
    Full Title: A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the...
    Medical condition: Mild/moderate COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) AT (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-004035-88 Sponsor Protocol Number: AntiCov Start Date*: 2021-11-18
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotro...
    Medical condition: Patients with mild to moderate SARS-COV-2 infection.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005051-37 Sponsor Protocol Number: NL78705.018.21 Start Date*: 2021-12-06
    Sponsor Name:Amsterdam University Medical Centre
    Full Title: TURN-COVID Biobank: The Dutch cohort study for the evaluation of the use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006495-16 Sponsor Protocol Number: PrEPSo Start Date*: 2022-02-25
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders
    Medical condition: Covid 19 Infection
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084458 COVID-19 prophylaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000724-35 Sponsor Protocol Number: 216912 Start Date*: 2021-05-11
    Sponsor Name:Vir Biotechnology, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Partici...
    Medical condition: Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-004188-28 Sponsor Protocol Number: Monet Start Date*: 2021-11-18
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Adaptative, Phase IV Randomized, Open-label, Multicenter Study to Determine the Safety and Efficacy of different MONoclonal Antibodies (MoAbs) to SARS-CoV-2 for the Early Treatment of COVID-19 in N...
    Medical condition: COVID-19 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000905-29 Sponsor Protocol Number: RENOIR Start Date*: 2022-04-12
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies
    Medical condition: Covid-19 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10047438 Viral infectious disorders HLGT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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