chufangao/CTO huggingface dataset:
Clinical trial NCT04311710: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
Official title: A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab
Acronym: CheckMate 76U
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 21.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-25
Primary completion date: 2021-01-14
Completion date: 2023-01-18
Clinical trial NCT03538015: Carvedilol in Treating Hypoglycemia Unawareness
Official title: The Use of Low-Dose Carvedilol to Improve Hypoglycemia Awareness in Patients With Type 1 Diabetes Mellitus
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor was impacted by COVID-19 and did not have sufficient funds to continue.
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-22
Primary completion date: 2020-08-10
Completion date: 2020-08-10
Baseline population: Study was terminated early and there were 0 participants enrolled into the Carvedilol 3.125 mg arm and 0 participants enrolled into the Carvedilol 2.5 mg arm
Plan to share individual participant data: NO
Clinical trial NCT01711515: Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer
Official title: A Phase I Trial of Sequential Ipilimumab After Chemoradiation for the Primary Treatment of Patients With Locally Advanced Cervical Cancer Stages IB2/IIA With Positive Para-Aortic Lymph Nodes Only and Stage IIB/IIIB/IVA With Positive Lymph Nodes
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-10-01
Primary completion date: 2017-02-09
Completion date: 2020-07-17
Clinical trial NCT03245827: Hypogonadotropic Hypogonadism in Obese Young Males
Official title: Hypogonadotropic Hypogonadism in Obese Young Males
Sponsor: St. Louis University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: not enough recruitment
Enrollment: 9.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-04-01
Primary completion date: 2021-10-29
Completion date: 2021-10-29
Baseline population: no subjects were recruited in placebo group
Plan to share individual participant data: NO
Clinical trial NCT05493501: Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer
Official title: A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib for Patients With Metastatic NSCLC and an EGFR Mutation (TREBLE)
Sponsor: EQRx International, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.
Enrollment: 8.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-12-14
Primary completion date: 2023-08-31
Completion date: 2023-08-31
Baseline population: Study terminated early, no participants completed the study, no participants were analyzed.
Clinical trial NCT02269670: Phase II Study of Everolimus Beyond Progression
Official title: Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow to accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-11-25
Primary completion date: 2021-01-25
Completion date: 2021-01-25
Baseline population: No data displayed because Outcome Measure has zero total analyzed.
Limitations and caveats: Early termination of the study because of recruitment difficulties lead to insufficient data collection and analysis of primary and secondary outcome measures.
Clinical trial NCT04060862: A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
Official title: A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
Acronym: IPATunity150
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The decision to not open the Phase III portion was based on a strategic sponsor decision and not driven by any safety concerns.
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-15
Primary completion date: 2023-08-29
Completion date: 2023-08-29
Plan to share individual participant data: NO
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04548700: Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL
Official title: Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The sponsor has adjusted its R\&D strategy.
Enrollment: 38.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-24
Primary completion date: 2023-06-30
Completion date: 2023-11-30
Clinical trial NCT05096832: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Study
Official title: A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
Acronym: COVID-19
Sponsor: Livzon Pharmaceutical Group Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 10381.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-03
Primary completion date: 2022-02-18
Completion date: 2023-04-14
Clinical trial NCT02961504: Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements
Official title: Placebo-Controlled, Double-Blind, Phase 2/3 Efficacy and Safety Trial of HLCM051 (MultiStem®) in Patients With Ischemic Stroke
Acronym: TREASURE
Sponsor: Healios K.K. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 206.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-15
Primary completion date: 2021-03-31
Completion date: 2023-02-28
Clinical trial NCT04617275: A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Official title: A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 151.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-01-06
Primary completion date: 2021-11-17
Completion date: 2021-11-17
Baseline population: A total of 151 participants were assigned to the treatment and treated with danuglipron or placebo.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT02959437: Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)
Official title: A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer (ECHO-206)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated by Sponsor
Enrollment: 70.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-02-27
Primary completion date: 2019-02-15
Completion date: 2020-03-02
Baseline population: No patients enrolled in Treatment Group B and C.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03626012: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis
Official title: A Phase 1 Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 Administered Intrathecally to Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 106.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-09-10
Primary completion date: 2021-11-17
Completion date: 2021-11-17
Clinical trial NCT04474626: Isoquercetin in Sickle Cell Anemia
Official title: Single-arm Phase 2 Study of Oral Isoquercetin in Sickle Cell Disease
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Trial did not activate
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-31
Primary completion date: 2022-12-31
Completion date: 2024-12-31
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 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: BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
Clinical trial NCT02904304: Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
Official title: National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold
Sponsor: Ache Laboratorios Farmaceuticos S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: the viability of the study is being analyzed
Enrollment: 150.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2021-07-31
Completion date: 2021-09-30
Clinical trial NCT04623086: Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
Official title: A Randomized Comparison of Transitioning From Insulin GLargine to Insulin Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in Patients With Type 1 Diabetes Mellitus - a Pilot Study
Acronym: GLIDING
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-14
Primary completion date: 2022-09-07
Completion date: 2023-12-31
Baseline population: We included all participants who had completed the treatment period in the final analysis. This included wearing the study continuous glucose monitor from time of randomization to study completion and implementing the transition from baseline insulin regimen to degludec (3 doses at least) according to protocol. We did not include subjects who either were Unassigned or Screen Failures as we could not obtain all the baseline characteristics in these two groups of participants.
Clinical trial NCT04394377: Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial
Official title: Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial
Acronym: ACTION
Sponsor: Brazilian Clinical Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 615.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-21
Primary completion date: 2021-03-26
Completion date: 2021-05-30
Plan to share individual participant data: YES
IPD sharing description: All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.
Clinical trial NCT01697293: PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer
Official title: A Phase I-II Study of PTX-200 Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer
Sponsor: Prescient Therapeutics, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: criteria for continuing enrollment in Phase 2 portion was not met
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-01-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT04115072: Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Official title: Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Sponsor: Regionshospital Nordjylland (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-03
Primary completion date: 2020-02-21
Completion date: 2020-02-21
Plan to share individual participant data: NO
Clinical trial NCT03922711: A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease
Official title: A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)
Sponsor: Prilenia (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19
Enrollment: 23.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-22
Primary completion date: 2020-07-22
Completion date: 2020-07-22
Baseline population: A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Limitations and caveats: The study was terminated early due to the COVID-19 pandemic.
Plan to share individual participant data: NO
Clinical trial NCT03478904: Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
Official title: Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study drug is now commercially available in tablet format
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-10
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Baseline population: No participants were enrolled to receive Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B)~Enzalutamide Liquid: Enzalutamide liquid formulation given orally (160mg)~Enzalutamide Capsule: Enzalutamide gel capsule (4X 40mg)
Plan to share individual participant data: NO
Clinical trial NCT05178342: Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes With CA-4948
Official title: A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients With Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS)
Acronym: LUCAS
Sponsor: University of Leipzig (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Prematurely according to trial protocol
Enrollment: 38.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-01
Primary completion date: 2024-07-31
Completion date: 2024-07-31
Plan to share individual participant data: NO
Clinical trial NCT03490838: 177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer
Official title: A Phase 1/2 Open-label, Multi-center, Dose-escalation Study of Safety, Tolerability, Pharmacokinetics, Dosimetry, and Response to Repeat Dosing of 177Lu-PSMA-R2 Radio-ligand Therapy in Patients With Prostate Specific Membrane Antigen (PSMA) Positive (68Ga-PSMA-R2) Progressive Metastatic Castration-resistant Prostate Cancer, Following Previous Systemic Treatment
Acronym: PROter
Sponsor: Advanced Accelerator Applications (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Recruitment for PROter A206T-G01-001 (NCT03490838) was halted in Phase I by sponsor decision. Phase II expansion portion of the study was never initiated.
Enrollment: 27.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-05-24
Primary completion date: 2021-05-26
Completion date: 2022-06-02
Plan to share individual participant data: NO
Clinical trial NCT04924257: ECT vs. Esketamine
Official title: Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study
Acronym: ETES
Sponsor: Medical University Innsbruck (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No eligible participants
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-28
Primary completion date: 2023-08-31
Completion date: 2024-04-30
Clinical trial NCT04571060: Randomized Trial in Adult Participants With Acute Migraines
Official title: Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1978.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-27
Primary completion date: 2021-10-10
Completion date: 2021-10-22
Baseline population: Treated participants included enrolled participants who took the study drug (zavegepant or placebo).
Clinical trial NCT03495921: A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide
Official title: A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma
Acronym: VITA
Sponsor: Gradalis, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Slow accrual and as a result, a strategic business decision was made to terminate enrollment.
Enrollment: 32.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-21
Primary completion date: 2022-01-20
Completion date: 2022-01-20
Baseline population: Only 1 subject randomized to Group B was eligible to Cross-over to receive Vigil.
Limitations and caveats: Early termination of trial leading to small numbers of subjects analyzed. Technical problems with measurement leading to unreliable or uninterpretable data.
Plan to share individual participant data: NO
Clinical trial NCT04040192: A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
Official title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 620.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-12
Primary completion date: 2022-01-19
Completion date: 2022-01-19
Baseline population: Evaluable OL population comprised of all participants who received at least 1 dose of study intervention in the OL period.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04381052: Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Official title: A Randomized Placebo-Controlled Safety and Dose-Finding Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-18
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Baseline population: Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Limitations and caveats: Study was closed due to no further development. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1). Assignment was not unblinded/disclosed.
Plan to share individual participant data: NO
IPD sharing description: Coded data will be shared with New York University (NYU) Langone for the purpose of statistical analysis and scientific reporting.