{"id":"W4226424068","doi":"10.1186/s13063-022-06219-7","title":"A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID)","year":2022,"lang":"en","type":"article","venue":"Trials","topic":"COVID-19 Clinical Research Studies","field":"Medicine","cited_by":6,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Universitat de Barcelona; Centres de Recerca de Catalunya; Generalitat de Catalunya; Canadian Institute for Theoretical Astrophysics","keywords":"Medicine; Icatibant; Randomized controlled trial; Randomization; Cytokine storm; Clinical trial; Internal medicine; Off-label use; Pneumonia; Coronavirus disease 2019 (COVID-19); Intensive care medicine; Infectious disease (medical specialty); Bradykinin; Disease","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.02208797,0.0003796752,0.003487281,0.0003036624,0.0003570378,0.00005272451,0.0006268087,0.0001097448,0.00004685202],"category_scores_gemma":[0.4021637,0.0002309972,0.0001305208,0.001432101,0.0004924452,0.0001252058,0.002543356,0.0006630595,7.52989e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002163448,"about_ca_system_score_gemma":0.002288586,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0002996513,"about_ca_topic_score_gemma":0.0001142874,"domain_scores_codex":[0.9850065,0.008486503,0.003779021,0.001009326,0.001297893,0.0004208157],"domain_scores_gemma":[0.9429066,0.05221552,0.00200507,0.0011562,0.0009920498,0.0007246049],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9417233,0.02862867,0.01896365,0.0002269928,0.0008206296,0.00002170198,0.003683263,0.00002633651,0.0003040333,0.00003201963,0.0001443052,0.005425045],"study_design_scores_gemma":[0.9019313,0.08656231,0.007527705,0.0002430524,0.0005906277,5.607612e-7,0.0003188256,0.0001252404,0.001322599,0.00003872474,0.00109828,0.000240724],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.6611782,0.000007051177,0.0003494471,0.002112797,0.0000926105,0.3361525,0.00008073292,0.0000228297,0.000003899724],"genre_scores_gemma":[0.8682606,0.000005460225,0.0004114957,0.001258321,0.00007586885,0.1299157,0.00002490073,0.00003350943,0.00001407533],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3800758,"threshold_uncertainty_score":0.9419791,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.4015424654767214,"score_gpt":0.5733146399548996,"score_spread":0.1717721744781782,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}