chufangao/CTO huggingface dataset:
Clinical trial NCT04435782: A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
Official title: A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging
Acronym: RESTORE
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The Sponsor decided to prematurely terminate the study due to the lower-than-expected recruitment rate.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-07
Primary completion date: 2023-07-28
Completion date: 2023-07-28
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Clinical trial NCT02866916: Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA)
Official title: Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer
Acronym: PROSTIRNA
Sponsor: Institut Claudius Regaud (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study cancelled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-30
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT04836806: Cetirizine and Famotidine for COVID-19
Official title: Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Cetirizine and Famotidine in Reducing the Duration of Symptoms in Patients With COVID-19: A Pilot Study
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study stopped due to issues with enrollment and lack of funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-31
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT04841538: A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors
Official title: An Open-label, Multicenter, Multicohort Phase 1b/2 Clinical Trial of ES101 in Patients With Advanced Malignant Thoracic Tumors
Sponsor: Elpiscience Biopharma, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor's clinical development strategy adjustment
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-07-31
Primary completion date: 2023-12-31
Completion date: 2024-05-31
Plan to share individual participant data: NO
Clinical trial NCT03175978: IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome
Official title: Pilot Study of IGF-Methotrexate Conjugate in the Treatment of Myelodysplastic Syndrome, CMML and Oligoblastic AML
Sponsor: IGF Oncology, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funding
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-21
Primary completion date: 2021-06-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT04583423: A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
Official title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 183.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-11-11
Primary completion date: 2023-04-13
Completion date: 2023-04-13
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04750239: Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer
Official title: Safety and Clinical Activity of Nivatrotamab, an Anti GD2×CD3 Bispecific Antibody, in Relapsed/Recurrent Metastatic Small-cell Lung Cancer An Open-label, Single-arm, Multicenter, Phase 1/2 Trial
Sponsor: Y-mAbs Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to business priorities
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-08-17
Primary completion date: 2022-04-08
Completion date: 2022-04-08
Baseline population: Safety Analysis Set
Limitations and caveats: The study was terminated after 3 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established. Only 3 subjects at dose level 1 (nivatrotamab 50 mcg) were enrolled.
Clinical trial NCT04231643: Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers
Official title: A Randomized, Controlled Trial of Cannabis in Bipolar Disorder Patients and Healthy Volunteers Evaluating Cognition and Endocannabinoid Levels
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Budgetary limitations prevented us from completing our planned sample size.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2023-11-28
Completion date: 2023-11-28
Plan to share individual participant data: NO
Clinical trial NCT03567616: A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study.
Enrollment: 8.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-10-18
Primary completion date: 2020-06-18
Completion date: 2020-06-18
Baseline population: Full Analysis Set: participants who received at least 1 dose of study drug
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03575351: A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Official title: A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).
Acronym: TRANSFORM
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 184.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-23
Primary completion date: 2023-10-23
Completion date: 2023-10-23
Clinical trial NCT04878211: A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Official title: An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.
Enrollment: 24.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-06-10
Primary completion date: 2023-04-14
Completion date: 2023-04-14
Baseline population: There were no participants enrolled in Cohort 3.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Clinical trial NCT03340909: The Norwegian Prednisolone in Early Psychosis Study
Official title: The Norwegian Prednisolone in Early Psychosis Study - NorPEPS. The Role of Immune-modulating Strategies in the Treatment of Psychosis
Acronym: NorPEPS
Sponsor: Haukeland University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Stopped because of COVID 19 pandemic
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-02
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT02657343: An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
Official title: An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-03-09
Primary completion date: 2020-08-27
Completion date: 2022-06-30
Baseline population: never enrolled to cohort C
Plan to share individual participant data: NO
Clinical trial NCT03336580: A Study of PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis
Official title: A Phase 1, Open-label, Dose Escalation Study of Intravenous PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis
Sponsor: Prothena Biosciences Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Because of the impact of COVID-19 pandemic
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-05
Primary completion date: 2020-07-23
Completion date: 2020-07-23
Plan to share individual participant data: NO
Clinical trial NCT04112199: A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
Official title: A Phase 2 Randomized, Dose-Titration, Open-Label Study Evaluating the Safety and Efficacy of BIV201 Compared to Standard of Care to Reduce Ascites and Complications in Cirrhotic Patients With Refractory Ascites
Sponsor: BioVie Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: For reasons unrelated to safety or efficacy
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-17
Primary completion date: 2023-05-08
Completion date: 2023-05-08
Plan to share individual participant data: NO
IPD sharing description: De-identified individual participant data for primary and secondary end-points may be made available after NDA filing.
Clinical trial NCT03988205: Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia
Official title: The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-28
Primary completion date: 2021-12-01
Completion date: 2022-04-01
Plan to share individual participant data: NO
Clinical trial NCT04124367: IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE
Official title: IMPULSE StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE A Prospective, Multi-center, Randomized, Double-blind Study to Assess Efficacy and Safety of Neuroplastic Intervention by Cerebrolysin and atDCS on Motor Function Recovery in Subacute and Chronic Stroke Patients
Acronym: IMPULSE
Sponsor: Ever Neuro Pharma GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: for strategic and pandemic reasons
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-25
Primary completion date: 2022-03-21
Completion date: 2022-03-21
Plan to share individual participant data: NO
Clinical trial NCT04792008: YQ23 Study in Patients With Critical Limb Ischaemia
Official title: A Randomised, Double-Blind, Phase 1b/2a, Placebo-Controlled, Single Dose Study to Evaluate Safety, Tolerability, and Efficacy of YQ23 in Adult Patients With Critical Limb Ischaemia
Acronym: YAN
Sponsor: New Beta Innovation Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to business decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-10
Primary completion date: 2023-08-31
Completion date: 2023-08-31
Plan to share individual participant data: NO
Clinical trial NCT02759588: GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer
Official title: Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15)
Sponsor: Genelux Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 46.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-05-31
Primary completion date: 2021-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03095612: Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)
Official title: An Investigator-sponsored, Phase 1/2 Trial of the Oral XPO1 Inhibitor Selinexor (KPT-330) Monotherapy and in Combination With Docetaxel for Previously Treated, Advanced KRAS Mutant Non-small Cell Lung Cancer (NSCLC)
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funding Sponsor no longer supporting study
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-22
Primary completion date: 2022-11-08
Completion date: 2023-03-03
Baseline population: 41 subjects were consented, but 1 screen failed and only 40 total were assigned to combination treatment cohort. 2nd dose level of 80 mg +docetaxel 75 mg/m2 was not tolerated and hence did not proceed to next dose of 100 mg+ docetaxel 75 mg/m2 as well. The study was halted prior to participants receiving any of the selinexor monotherapy. No data was collected or analyzed for the selinexor Monotherapy cohort.
Plan to share individual participant data: NO
Clinical trial NCT04372082: Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19
Official title: Efficacy of HYdroxychloroquine and DILtiazem-nIClosamide Combination for the Treatment of Non-severe Forms of SARS-CoV2 Infection in Patients With Co-morbidities: Multicenter, Randomized, Open-labeled Controlled Trial
Acronym: HYdILIC
Sponsor: University Hospital, Lille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: evidence showed chloroquine is not effective against COVID-19
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-31
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Clinical trial NCT03703336: Phase III Study of Liquid Formulation of ROTAVIN
Official title: A Phase III, Randomized, Partially Double- Blind, Active Control Study to Compare the Immunogenicity and Safety of a Liquid Formulation of ROTAVIN With the Currently Licensed Frozen Formulation of the Vaccine (ROTAVIN-M1), in Healthy Vietnamese Infants
Sponsor: Center for Research and Production of Vaccines and Biologicals, Vietnam (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 825.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-16
Primary completion date: 2020-01-08
Completion date: 2020-01-08
Baseline population: Safety population, as treated
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02539225: A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of S-1 and Oxaliplatin With or Without Ramucirumab as First-line Therapy Followed by Paclitaxel With Ramucirumab as Second-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 191.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-05
Primary completion date: 2017-10-25
Completion date: 2021-03-10
Baseline population: All randomized participants who received any quantity of study drug.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04149379: Hyperbaric Oxygen Therapy After Stroke - PILOT
Official title: Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT
Sponsor: Norwegian Underwater Intervention (NUI) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Because of the economic consequences of the COVID-19 pandemic 2020
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-20
Primary completion date: 2021-08-31
Completion date: 2021-12-20
Plan to share individual participant data: NO
Clinical trial NCT04349098: Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
Official title: A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection
Acronym: Coronavirus
Sponsor: Karyopharm Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 190.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2020-10-05
Completion date: 2020-10-05
Baseline population: PV 1-6 population included participants randomized into the study under protocol versions 1-6.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04519567: Multiple Ascending Dose Study of CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia
Official title: A Phase 1 Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CTI-1601 Versus Placebo in Subjects With Friedreich's Ataxia
Sponsor: Larimar Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-31
Primary completion date: 2021-03-16
Completion date: 2021-03-16
Clinical trial NCT03844932: A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis
Sponsor: Sublimity Therapeutics Holdco Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sublimity Board of Directors carefully evaluated the IA data: the 9.6% treatment remission difference for 75mg BID vs placebo (due to an increase in placebo response rate) was determined not sufficient to continue to fund the study
Enrollment: 235.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-24
Primary completion date: 2021-04-14
Completion date: 2021-04-14
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04771780: Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Official title: A Phase 3, Long-term, Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 213.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-15
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Plan to share individual participant data: YES
IPD sharing description: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
Clinical trial NCT04502433: Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Official 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 Distress Syndrome (ARDS)
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The enrolment was extended. Nevertheless, despite the Sponsor's attempts, the infection status did not permit the identification of eligible patients for the study to complete it in a reasonable time.
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-06
Primary completion date: 2022-03-17
Completion date: 2022-03-17
Baseline population: Intention-to-Treat (ITT) population used for this parameter.
Limitations and caveats: Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.
Plan to share individual participant data: NO