[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04326426":3,"trial-entities:NCT04326426":100,"trial-summary:NCT04326426":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":41,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":80,"locations":83,"central_contacts":92,"overall_officials":93,"references":94,"see_also_links":99},"NCT04326426","VLY-686-3501","ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection","ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection","ENROLLING_BY_INVITATION","2020-08-31","2020-04","2020-04-20","2020-04-13","Vanda Pharmaceuticals","INDUSTRY",null,"This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection.\n\nOn evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.",[18],"Coronavirus Infection",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE3",{"count":25,"type":26},300,"ESTIMATED",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Tradipitant","Neurokinin-1 antagonist",[30],{"type":29,"name":34,"description":35,"armGroupLabels":36},"Placebo","Matching placebo",[34],[38],{"measure":39,"timeFrame":40},"Time to improvement on a 7-point ordinal scale as compared to baseline","14 days or discharge",[42,44,46,48,50,52,54,56,58],{"measure":43,"timeFrame":40},"Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)",{"measure":45,"timeFrame":40},"Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples",{"measure":47,"timeFrame":40},"In-hospital mortality",{"measure":49,"timeFrame":40},"Mean change in NEWS2 score from baseline",{"measure":51,"timeFrame":40},"Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus",{"measure":53,"timeFrame":40},"Reduction from baseline of NRS for cough",{"measure":55,"timeFrame":40},"Reduction from baseline of NRS for nausea",{"measure":57,"timeFrame":40},"Time to normalization of fever for at least 48 hours",{"measure":59,"timeFrame":40},"Time to improvement in oxygenation for at least 48 hours","ALL","18 Years","90 Years",false,{"inclusion":65,"exclusion":72,"raw_text":79},[66,67,68,69,70,71],"Adults aged 18-90","Confirmed laboratory COVID-19 infection by RT-PCR","Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital","Confirmed pneumonia by chest radiograph or computed tomography","Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal","Oxygen saturation less than 92%",[73,74,75,76,77,78],"Recent use of illicit drugs or alcohol abuse","Known allergy to tradipitant or other neurokinin-1 antagonists","Pregnancy","Known HIV, HBV, or HCV infection","Malignant tumor, other serious systemic diseases","Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements","Inclusion Criteria:\n\n* Adults aged 18-90\n* Confirmed laboratory COVID-19 infection by RT-PCR\n* Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital\n* Confirmed pneumonia by chest radiograph or computed tomography\n* Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal\n* Oxygen saturation less than 92%\n\nExclusion Criteria:\n\n* Recent use of illicit drugs or alcohol abuse\n* Known allergy to tradipitant or other neurokinin-1 antagonists\n* Pregnancy\n* Known HIV, HBV, or HCV infection\n* Malignant tumor, other serious systemic diseases\n* Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"city":86,"state":86,"zip":87,"country":88,"geoPoint":89},"Lenox Hill Hospital Northwell Health","New York","10075","United States",{"lat":90,"lon":91},40.71427,-74.00597,[],[],[95],{"pmid":96,"type":97,"citation":98},"34353696","DERIVED","Smieszek SP, Przychodzen BP, Polymeropoulos VM, Polymeropoulos CM, Polymeropoulos MH. Assessing the potential correlation of polymorphisms in the IL6R with relative IL6 elevation in severely ill COVID-19 patients'. Cytokine. 2021 Dec;148:155662. doi: 10.1016\u002Fj.cyto.2021.155662. Epub 2021 Jul 29.",[],{"nct_id":4,"conditions":101,"biomarkers":103},[102],"COVID-19 Infection",[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is a randomized, double-blind, placebo-controlled study involving 300 participants. Participants will be randomly assigned to receive either tradipitant or a placebo.","completed","ODYSSEY: Tradipitant for Severe or Critical COVID-19 Infection","This study, called ODYSSEY, is testing an investigational drug called tradipitant to see if it can help people with severe or critical COVID-19 infection. Researchers want to find out if tradipitant is safe and effective in treating the lung inflammation caused by the virus. You might be able to join if you are an adult aged 18-90, have a confirmed COVID-19 infection, and meet the hospital's criteria for severe or critical COVID-19 with pneumonia and fever. The main goal is to see how quickly participants improve on a 7-point scale, measured at 14 days or when they leave the hospital. The current status of the study is unclear.","Your improvement will be measured at 14 days or upon hospital discharge.",108,"If you join, you will receive either tradipitant or a placebo twice daily by mouth, in addition to standard COVID-19 care. You will have daily assessments of your NEWS 2 score and daily blood tests for inflammatory markers.","Not stated in the trial record.",[30],"v2"]