chufangao/CTO huggingface dataset:
Clinical trial NCT04274933: A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy
Official title: A Phase 1b Study of Venetoclax and Capecitabine In Subjects With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Experienced Disease Progression During or After CDK4/6 Inhibitor Therapy
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Company Decision
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-21
Primary completion date: 2020-10-08
Completion date: 2020-10-08
Plan to share individual participant data: NO
Clinical trial NCT04231526: Pembrolizumab in Early Stage Colon Cancer
Official title: A Window of Opportunity Study of Pembrolizumab in Colon Cancer
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: unable to accrue
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-20
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Clinical trial NCT05638334: Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours
Official title: An Open Label, Multicentre, Positron Emission Tomography (PET) Imaging Study Using Zirconium-89 to Investigate the Biodistribution and Tumour Uptake of a PD-L1x4-1BB Bispecific Antibody (S095012) in Patients With Advanced Solid Tumours
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-21
Primary completion date: 2024-06-14
Completion date: 2024-06-14
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier.~* with a first patient enrolled as of 1 January 2004 onwards.~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT03389555: Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
Official title: Ascorbic Ccid, Hydrocortisone, and Thiamine in Sepsis and Septic Shock - A Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 205.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-09
Primary completion date: 2019-11-26
Completion date: 2020-02-28
Limitations and caveats: Ongoing or planned corticosteroid use was the most common exclusion criterion, perhaps eliminating a subset of patients more likely to benefit from corticosteroids. Some patients were discharged alive from the ICU within 96 hours of enrollment; thus, many patients did not receive a full 4 days of study drug
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04659369: Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
Official title: Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Difficult to recruit subjects
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-24
Primary completion date: 2023-10-16
Completion date: 2023-10-16
Clinical trial NCT03397394: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Official title: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Acronym: ATLAS
Sponsor: pharmaand GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.
Enrollment: 97.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-01
Primary completion date: 2019-12-12
Completion date: 2020-01-15
Limitations and caveats: The study was terminated early based on an interim analysis by the Data Monitoring Committee that demonstrated that ORR did not meet the protocol-defined continuance criteria. There were no confirmed responses observed.
Clinical trial NCT03995641: The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation
Official title: The Effect of Local Analgesia on Postoperative Gluteal Pain in Patients Undergoing Sacrospinous Ligament Fixation: A Randomized Trial
Sponsor: Kettering Health Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Never received appropriate formulation.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-02
Primary completion date: 2023-09-12
Completion date: 2023-09-12
Clinical trial NCT04048707: Angiotensin 2 for Hepatorenal Syndrome
Official title: Angiotensin 2 as a Novel Treatment for Hepatorenal Syndrome
Acronym: ANTHEM
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding issues; the study was never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-01
Primary completion date: 2023-06-30
Completion date: 2023-07-01
Plan to share individual participant data: NO
Clinical trial NCT05016661: Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention
Official title: A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache
Sponsor: AEON Biopharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated due to the analysis of the data not meeting the intended primary endpoint and key secondary endpoints.
Enrollment: 466.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-19
Primary completion date: 2024-07-31
Completion date: 2024-08-30
Plan to share individual participant data: NO
IPD sharing description: Individual Participant Data collected during the trial, after deidentification may be shared following review of the clinical study report by the FDA review division and if a decision is made to publish the results in a publication outside posting the results in clinicaltrials.gov.
Clinical trial NCT03717155: Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC
Official title: A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous NSCLC
Sponsor: Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-30
Primary completion date: 2020-09-30
Completion date: 2021-05-27
Clinical trial NCT05207514: Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Official title: Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Sponsor: Samyang Biopharmaceuticals Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Decision to Terminate Early Due to Difficulties in Recruiting Participants and Conducting the Study.
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-31
Primary completion date: 2024-02-07
Completion date: 2024-05-09
Clinical trial NCT03974854: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma
Official title: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX)
Acronym: ALIX
Sponsor: Centre Hospitalier Universitaire de Besancon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: sponsor decision
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-08
Primary completion date: 2023-08-01
Completion date: 2024-02-01
Plan to share individual participant data: NO
Clinical trial NCT04737161: Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome
Official title: A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS)
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funding not secured
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-31
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT03722186: Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
Official title: An Open-label, Single-arm, Phase I Study of the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of SHR-1603 in Subjects With Advanced Solid Tumor or Relapsed/Refractory Lymphoma
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Business Decision
Enrollment: 128.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2018-11-13
Primary completion date: 2019-04-04
Completion date: 2021-10-31
Plan to share individual participant data: NO
Clinical trial NCT02209545: Misoprostol for Reduction of Blood Loss During Fibroid Surgery
Official title: Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was prematurely closed due to low enrollment rates.
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-31
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT05182840: A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Official title: Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 714.0 (ACTUAL)
Number of arms: 10.0
Start date: 2022-01-11
Primary completion date: 2023-06-19
Completion date: 2023-07-10
Baseline population: Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not.
Plan to share individual participant data: YES
IPD sharing description: Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD time frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Clinical trial NCT02128958: Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
Official title: A Phase 2 Study in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects With Child-Pugh Class B Cirrhosis
Sponsor: Can-Fite BioPharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 78.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-09-30
Primary completion date: 2017-11-27
Completion date: 2021-12-31
Clinical trial NCT04118036: Abemaciclib + Pembrolizumab In Glioblastoma
Official title: A Phase 2 Study of Abemaciclib and Pembrolizumab in Recurrent Glioblastoma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Safety concerns
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2023-12-01
Completion date: 2024-12-01
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT05001724: KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent
Official title: A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Compare Efficacy, Safety, and Tolerability of KN046 Combined With Lenvatinib Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer After Failure of Anti-PD-(L)1 Agent
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Because the efficacy data did not meet expectations, the sponsor decided to terminate the study.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-28
Primary completion date: 2023-02-13
Completion date: 2023-04-07
Plan to share individual participant data: NO
Clinical trial NCT01977417: Inflammation Inhibition in Prediabetic Humans
Official title: Inflammation Inhibition for Microvascular and Autonomic Dysfunction in Obese Prediabetic Humans
Acronym: INCITE
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No funding
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-11-30
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Plan to share individual participant data: NO
Clinical trial NCT04650204: Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Official title: A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The funding sponsor, EISAI, sold the US rights to the medication and can no longer provide it to patients for the study.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-04
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Limitations and caveats: Study was terminated due to the funding sponsor(EISAI) sold the US rights to the medication and can no longer provide it to patients for the study.
Clinical trial NCT03236506: A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
Official title: A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
Acronym: ADVANCE
Sponsor: University of Dundee (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 129.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-19
Primary completion date: 2020-08-31
Completion date: 2020-10-28
Plan to share individual participant data: NO
Clinical trial NCT04219319: LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma
Official title: A Phase I, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Patiens
Sponsor: The First Affiliated Hospital with Nanjing Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Both the sponsors and collaborator are considering terminating the study
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-15
Primary completion date: 2022-07-20
Completion date: 2022-07-20
Clinical trial NCT04074161: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
Official title: Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity
Acronym: STEP 8
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 338.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-09-11
Primary completion date: 2021-03-27
Completion date: 2021-05-11
Baseline population: The full analysis set (FAS) included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04653038: A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma
Official title: An Open-label, Multi-cohort, Multi-center Phase I Study Evaluating the Efficacy and Safety of MGD013 in Patients With Unresectable, Recurrent or Metastatic Malignant Melanoma
Sponsor: Zai Lab (Hong Kong), Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: rapid changes in the treatment mode of melanoma worldwide and in China and the development strategy change
Enrollment: 92.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-29
Primary completion date: 2022-03-02
Completion date: 2022-03-02
Clinical trial NCT03605836: A Trial to Evaluate the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Official title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 590.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-16
Primary completion date: 2020-05-14
Completion date: 2020-05-14
Baseline population: Participants who participated only in the Run-in Period and Full Analysis Set (FAS) of the Double-blind Treatment Period including all participants of the safety sample of Double-blind Treatment Period who had a Baseline value and at least one valid post-randomization efficacy evaluation for adult ADHD investigator symptom rating scale (AISRS) total score in the Double-blind Treatment Period.
Plan to share individual participant data: YES
IPD sharing description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD access criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Clinical trial NCT03788343: Phenylalanine and Its Impact on Cognition
Official title: PICO: Phenylalanine and Its Impact on Cognition - Impact of Phenylalanine on Cognitive, Cerebral and Neurometabolic Parameters in Adult Patients With Phenylketonuria
Acronym: PICO
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-19
Primary completion date: 2022-06-17
Completion date: 2022-06-17
Plan to share individual participant data: NO
Clinical trial NCT02982694: Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer
Official title: A Phase II Open-label Study With the Anti-PD-L1 Atezolizumab Monoclonal Antibody in Combination With Bevacizumab in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and MSI-like Molecular Signature
Sponsor: Vall d'Hebron Institute of Oncology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The results of the interim analysis showed that the efficacy in the MSS subgroup (MSI like) is inferior to the expected, and this situation is very unlikely to be reversed if the trial is fully completed.
Enrollment: 46.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-24
Primary completion date: 2020-11-27
Completion date: 2020-11-27
Clinical trial NCT04546581: Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
Official title: An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
Sponsor: University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 593.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-08
Primary completion date: 2021-05-21
Completion date: 2021-05-21
Plan to share individual participant data: YES
IPD sharing description: A public data set will be made available at the end of the trial