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Clinical trials for Respiratory Distress Syndrome (RDS)

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   44351   clinical trials with a EudraCT protocol, of which   7378   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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    55 result(s) found for: Respiratory Distress Syndrome (RDS). Displaying page 2 of 3.
    EudraCT Number: 2020-005863-29 Sponsor Protocol Number: HelmetHeparin Start Date*: 2021-07-15
    Sponsor Name:ASST FATEBENEFRATELLI SACCO
    Full Title: Nebulised heparin in COVID-19-related ARDS patients undergoing non-invasive ventilation with helmet cPAP: a prospective, randomised, double blind, placebo-controlled, multicentre study
    Medical condition: COVID-19-related Acute Respiratory Distress Syndrome (ARDS) patients undergoing non-invasive ventilation with helmet continuous positive airway pressure (cPAP)
    Disease: Version SOC Term Classification Code Term Level
    22.0 10042613 - Surgical and medical procedures 10052956 CPAP LLT
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    21.1 100000004855 10003083 ARDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001420-34 Sponsor Protocol Number: 0001 Start Date*: 2020-04-14
    Sponsor Name:Aarhus University
    Full Title: Senicapoc in COVID-19 Patients with Severe Respiratory Insufficiency – A Randomized, Open-Label, Phase II Trial
    Medical condition: Infection with COVID19
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-003486-19 Sponsor Protocol Number: 1.002.20 Start Date*: 2020-10-08
    Sponsor Name:University of Dundee
    Full Title: A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or con...
    Medical condition: Community acquired pneumonia with suspected or confirmed SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10066724 Acute pneumonia LLT
    20.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    23.0 10021881 - Infections and infestations 10084380 COVID-19 pneumonia PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-020403-75 Sponsor Protocol Number: ACEmeVent-Pilot Start Date*: 2011-10-24
    Sponsor Name:Universität Leipzig
    Full Title: ACE inhibitor for lung protection during mechanical Ventilation for acute lung injury - pilot trial
    Medical condition: acute lung injury, ALI/ARDS
    Disease: Version SOC Term Classification Code Term Level
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10069351 Acute lung injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003923-40 Sponsor Protocol Number: APHP200019 Start Date*: 2021-01-08
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)
    Full Title: A Multicentre Concealed‐Allocation Parallel‐Group Blinded Randomized Controlled Trial to Ascertain the Effect of High‐Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ...
    Medical condition: Sepsis complicated by ARDS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004706-22 Sponsor Protocol Number: ImlifidARDSe.01 Start Date*: 2023-02-17
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: Imlifidase in ANCA-associated vasculitis
    Medical condition: Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis with severe diffuse alveolar hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10072579 Granulomatosis with polyangiitis PT
    27.0 10047065 - Vascular disorders 10063344 Microscopic polyangiitis PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037314 Pulmonary alveolar hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005260-15 Sponsor Protocol Number: FPCLI002 Start Date*: 2016-02-10
    Sponsor Name:Faron Pharmaceuticals Ltd
    Full Title: A Phase III Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Treatment of Patients with Modera...
    Medical condition: Adult patients diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10003083 ARDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FI (Prematurely Ended) BE (Completed) ES (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002122-82 Sponsor Protocol Number: UKER-COV2-01 Start Date*: 2020-06-12
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Prospective open-label randomized controlled phase 2b clinical study in parallel groups for the assessment of efficacy and safety of immune therapy with COVID-19 convalescent plasma plus standard t...
    Medical condition: ARDS due to COVID-19 necessitating invasive mechanical ventilation
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084270 SARS-CoV-2 acute respiratory disease LLT
    21.1 100000004855 10003083 ARDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001078-27 Sponsor Protocol Number: 19999 Start Date*: 2020-06-16
    Sponsor Name:Bayer AG
    Full Title: Safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) in patients suffering from Acute Respiratory Distress Syndrome (ARDS): a double-blind, randomized, placebo-controlled, multicenter ...
    Medical condition: Acute respiratory distress syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001052 Acute respiratory distress syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Completed) AT (Prematurely Ended) IT (Prematurely Ended) GR (Prematurely Ended) NL (Prematurely Ended) BE (Completed) DK (Prematurely Ended) IE (Prematurely Ended) FI (Prematurely Ended) HU (Prematurely Ended) SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001244-26 Sponsor Protocol Number: COV-2-SOLNATIDE-20 Start Date*: 2020-04-11
    Sponsor Name:Department of Clinical Pharmacology, Medical University of Vienna, Vienna Austria
    Full Title: COVID-19: Efficacy of solnatide to treat pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS - a pilot-trial.
    Medical condition: Pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003083 ARDS LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037423 Pulmonary oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-002312-29 Sponsor Protocol Number: INOT -27 Start Date*: 2005-01-10
    Sponsor Name:INO Therapeutics
    Full Title: The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants.
    Medical condition: Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10054933 LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) GB (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000489-37 Sponsor Protocol Number: SURF-04-01 Start Date*: 2005-08-26
    Sponsor Name:Nektar Therapeutics
    Full Title: An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery...
    Medical condition: The medical condition for this application is the Respiratory Distress Syndrome (RDS). RDS, also known as hyaline membrane disease, is characterized by lung immaturity and surfactant deficiency a...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002632-75 Sponsor Protocol Number: CLI-050000-04 Start Date*: 2020-07-08
    Sponsor Name:CHIESI FARMACEUTICI S.p.A
    Full Title: Multicenter, open-label, randomised trial to assess the efficacy and tolerability of poractant alfa (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 acute respiratory distr...
    Medical condition: patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003855-47 Sponsor Protocol Number: AP301-II-002 Start Date*: 2018-02-27
    Sponsor Name:Apeptico Forschung und Entwicklung GmbH
    Full Title: Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlle...
    Medical condition: pulmonary permeability oedema in patients with moderate-to-severe ARDS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003083 ARDS LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037423 Pulmonary oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001302-30 Sponsor Protocol Number: ACOVACT Start Date*: 2020-04-15
    Sponsor Name:Medical University of Vienna
    Full Title: A multicenter, randomized, active controlled, open label, platform trial on the efficacy and safety of experimental therapeutics for patients with COVID-19 (caused by infection with severe acute re...
    Medical condition: Infection with SARS-COV-2 (=COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    21.1 100000004855 10003083 ARDS LLT
    20.0 10021881 - Infections and infestations 10038700 Respiratory infection LLT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002322-85 Sponsor Protocol Number: KAN0006 Start Date*: 2020-07-02
    Sponsor Name:Kancera AB
    Full Title: KAND567 Versus Placebo in Subjects Hospitalized with COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics.
    Medical condition: Acute respiratory distress syndrome (ARDS) in COVID-19 infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001974-14 Sponsor Protocol Number: CCD-050000-01 Start Date*: 2023-08-11
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant a...
    Medical condition: Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-003106-72 Sponsor Protocol Number: IIBSP-SUR-2022-61 Start Date*: 2023-05-26
    Sponsor Name:Institut de Recerca H. de la Santa Creu i Sant Pau
    Full Title: Single-blind randomized clinical trial in premature infants with Respiratory Distress Syndrome (RDS) amenable to treatment with exogenous surfactant identified early by pulmonary ultrasonography
    Medical condition: Respiratory Distress Syndrome
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-001563-37 Sponsor Protocol Number: Prot-Cur 3. Start Date*: 2006-10-10
    Sponsor Name:Department of Pediatrics Holbaek Hospital
    Full Title: Tidlig selektiv behandling med Curosurf. Behandling af RDS efter bestemmelse af lamellar body counts på ventrikelaspirat sammenholdt med behandling ved a/APO2 <0,36 En randomiseret kontrolleret mul...
    Medical condition: Respiratory Distress Syndrome (RDS) in infants 24-29 weeks`gestation
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005059-35 Sponsor Protocol Number: TMP-2204-2021-47 Start Date*: 2022-01-25
    Sponsor Name:F4-Pharma GmbH i.G.
    Full Title: Potential of FX06 to improve disease severity in Acute Respiratory Distress Syndrome patients (Ixion 2.0)
    Medical condition: Acute Respiratory Distress Syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003083 ARDS LLT
    24.0 10038738 - Respiratory, thoracic and mediastinal disorders 10085269 ARDS disease progression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) LT (Trial now transitioned) PT (Prematurely Ended) IT (Prematurely Ended) NL (Completed) RO (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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