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Clinical trials for covid-19 and sarilumab

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   44335   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    15 result(s) found for: covid-19 and sarilumab. Displaying page 1 of 1.
    EudraCT Number: 2020-001390-76 Sponsor Protocol Number: ESCAPE Start Date*: 2020-04-27
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: A phase 3, randomized, open-labeled, multi-center study comparing clinical efficacy and safety of intravenous sarilumab plus standard of care compared to standard of care, in the treatment of patie...
    Medical condition: Covid-19 coronavirus infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004855 10047468 Viral lower respiratory tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001745-40 Sponsor Protocol Number: COVID-SARI-001 Start Date*: 2020-04-23
    Sponsor Name:ASST FATEBENEFRATELLI SACCO
    Full Title: PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION
    Medical condition: Patients with COVID-19 infection
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004862 10048847 Lung infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002037-15 Sponsor Protocol Number: SARTRE Start Date*: 2020-05-25
    Sponsor Name:Cristina Avendaño Sola
    Full Title: Multicenter, randomized, open-label study to evaluate the efficacy and safety of SOC + Sarilumab versus Standard of Care for the Early Treatment of COVID-19-pneumonia in Hospitalized Patients
    Medical condition: SARS-CoV-2 infected patients with pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001634-36 Sponsor Protocol Number: SARCOVID Start Date*: 2020-04-09
    Sponsor Name:Rosario García de Vicuña
    Full Title: Randomized open pilot study to evaluate the efficacy of subcutaneous sarilumab in patients with moderate-severe COVID-19 infection.
    Medical condition: COVID-19 infection requiring hospitalization
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-001255-40 Sponsor Protocol Number: STRIKE-SARS-CoV2 Start Date*: 2020-04-16
    Sponsor Name:Clínica Universidad de Navarra/Universidad de Navarra
    Full Title: Sarilumab Treatment In cytoKinE storm caused by infection with COVID-19.
    Medical condition: Severe pneumonia caused by infection with SARS CoV 2.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10051905 Coronavirus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-001162-12 Sponsor Protocol Number: EFC16844 Start Date*: 2020-03-26
    Sponsor Name:Sanofi-aventis Recherche et Développement
    Full Title: An adaptive phase 3, randomized, double-blind, placebo-controlled, study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19
    Medical condition: Corona virus infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10053983 Corona virus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-001290-74 Sponsor Protocol Number: SARICOVID Start Date*: 2020-04-11
    Sponsor Name:Consorci Parc de Salut Mar (PSMAR)
    Full Title: Efficacy and safety of sarilumab in the early treament of hospitalized patients with mild-moderate neumonia and COVID19 infection versus standard of care
    Medical condition: Patients with confirmed COVID-19 infection and criteria for mild-moderate pneumonia (CURB-65 ≤1 i SatO2 ≥90%, MEWS score less than 3) and IL6 values of 20 pg / ml, will be randomly assigned to a sa...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001531-27 Sponsor Protocol Number: SARICOR Start Date*: 2020-04-18
    Sponsor Name:Fundación para la Investigación Biomédica de Córdoba
    Full Title: Clinical trial of Sarilumab in adults hospitalized with COVID-19 presenting cytokine release syndrome
    Medical condition: SARS-CoV-2 infection causing respiratory disease and cytokine release syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10051905 Coronavirus infection LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001367-88 Sponsor Protocol Number: 25032020 Start Date*: 2020-04-14
    Sponsor Name:Department of Infectious diseases
    Full Title: Efficacy and safety of novel treatment options for adults with COVID-19 pneumonia. A double-blinded, randomized, multi-stage, 6-armed placebo-controlled trial in the framework of an adaptive trial ...
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001854-23 Sponsor Protocol Number: AMMURAVID Start Date*: 2020-04-27
    Sponsor Name:SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI
    Full Title: Cumulative adaptive, multiarm, multistage and multicentre randomized clinical trial with immunotherapy for Moderate COVID-19
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001357-52 Sponsor Protocol Number: EnCovid-hidroxiCLOROQUINA Start Date*: 2020-05-13
    Sponsor Name:IDIVAL
    Full Title: Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in...
    Medical condition: Quimioprophylaxis of SARS-CoV-2 infection with hydroxyloquine (HCQ) in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or J...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021982 Inflammatory disorders following infection HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001275-32 Sponsor Protocol Number: APPI2-CV-2020-01 Start Date*: 2020-04-03
    Sponsor Name:The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
    Full Title: Effectiveness of Interleukin-6 Receptor Inhibitors in the Management of Patients with Severe SARS-CoV-2 Pneumonia: An Open-Label Multicenter Sequential Randomized Controlled Trial
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004848 10070267 SARS virus test positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001246-18 Sponsor Protocol Number: APHP200375 Start Date*: 2020-03-25
    Sponsor Name:Assistance Publique - Hôpitaux de Paris
    Full Title: Cohort Multiple randomized controlled trials open-label of immune modulatory drugs and other treatments in COVID-19 patients
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-002340-14 Sponsor Protocol Number: REMAP-CAP Start Date*: 2015-09-16
    Sponsor Name:University Medical Center Utrecht
    Full Title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP). (COVID-19)
    Medical condition: Severe Community Acquired Pneumonia COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) IE (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Completed) BE (Trial now transitioned) DE (Ongoing) HR (Trial now transitioned) ES (Temporarily Halted) FR (Trial now transitioned) FI (Ongoing) IT (Trial now transitioned) CZ (Trial now transitioned) SI (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000169-42 Sponsor Protocol Number: KPL-404-C211 Start Date*: 2022-10-28
    Sponsor Name:Kiniksa Pharmaceuticals, Ltd.
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects with Moderate to Severe, Active Rheumatoid Art...
    Medical condition: Rheumatoid arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) HU (Completed) BG (Completed)
    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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