chufangao/CTO huggingface dataset:
Clinical trial NCT03208231: Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
Official title: Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 With Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-06
Primary completion date: 2020-06-16
Completion date: 2021-02-11
Limitations and caveats: Accrual into the study was terminated early due to the outbreak of coronavirus disease 2019 (COVID-19), with 60 evaluable infants out of the targeted 68.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification.
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
IPD access criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.~* For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.~* By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT Data Request form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Clinical trial NCT02133521: DLBS1033 for Acute Ischemic Stroke Patients
Official title: Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients
Acronym: ADDLIST
Sponsor: Dexa Medica Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Very low recruitment rate. The Study Sites classified as tertiary referral hospital. Therefore, patients being referred to the site are mostly those with comorbidities included in the exclusion criteria.
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-11-11
Primary completion date: 2023-02-21
Completion date: 2023-04-21
Clinical trial NCT03439943: Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
Official title: Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease
Acronym: LixiPark
Sponsor: University Hospital, Toulouse (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 156.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-13
Primary completion date: 2021-04-15
Completion date: 2021-04-15
Clinical trial NCT03759288: An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Official title: A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)
Acronym: INTREPID
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Enrollment: 89.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-12-07
Primary completion date: 2023-10-18
Completion date: 2023-10-18
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT05086744: Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders
Official title: An Open-label, Multi-center, Phase 2 Basket Study to Assess Efficacy, Safety and Pharmacokinetics of Iptacopan (LNP023) in Participants With Autoimmune Benign Hematological Disorders
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-21
Primary completion date: 2023-09-20
Completion date: 2024-05-17
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 applicable 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 www.clinicalstudydatarequest.com
Clinical trial NCT03862716: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
Official title: Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial
Acronym: REMITiDegLira
Sponsor: Population Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-23
Primary completion date: 2022-06-15
Completion date: 2023-07-31
Clinical trial NCT03705390: A Safety and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS)
Official title: A Phase II Pilot Single-arm Safety and Tolerability Study of ILB in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS)
Acronym: ALS
Sponsor: University of Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-29
Primary completion date: 2021-07-28
Completion date: 2021-07-28
Plan to share individual participant data: NO
Clinical trial NCT02797119: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery
Official title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk
Acronym: TRACES
Sponsor: University Hospital, Lille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study will be stopped due to the impossibility of reaching the objective of inclusions within a reasonable time frame and taking into account the recommendations of the international WOMAN study
Enrollment: 225.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-03-15
Primary completion date: 2021-04-15
Completion date: 2021-04-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04558281: Continuous Erector Spinae Plane Blocks for Rib Fractures
Official title: Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Could only enroll 4 subjects in nearly 2 years
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-23
Primary completion date: 2022-03-26
Completion date: 2023-03-24
Plan to share individual participant data: NO
Clinical trial NCT03111069: Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children
Official title: A Phase I Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI withdrew study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-31
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Clinical trial NCT04399837: A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
Official title: Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP.
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 123.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-04
Primary completion date: 2022-11-23
Completion date: 2022-11-23
Baseline population: Randomized Set: This patient set includes all randomized patients.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing find information in order to 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.~The data shared are the raw clinical study data sets.
IPD time frame: After 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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT02620007: Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease
Official title: Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease
Acronym: TEOREM
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: insufficient recruitment
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-31
Primary completion date: 2021-08-31
Completion date: 2022-06-30
Clinical trial NCT04680676: A Study to Test Different Doses of BI 730357 and Find Out Whether They Reduce Symptoms in People With Active Psoriatic Arthritis
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging, Proof-of-concept Trial of BI 730357 Given for 12 Weeks in Patients With Active Psoriatic Arthritis
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Program discontinued
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-02
Primary completion date: 2023-06-26
Completion date: 2023-09-25
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT05129423: A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Development of MTPS9579A was terminated for strategic/business reasons.
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-07-31
Primary completion date: 2024-07-31
Completion date: 2024-08-31
Plan to share individual participant data: YES
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 NCT03476044: Effect of Selenium on Succinylcholine-Induced POM
Official title: Effect of Selenium on Succinylcholine-Induced Postoperative Myalgia After Adult Sinuscopic Procedures
Sponsor: Assiut University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-01
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Clinical trial NCT02772679: T1DM Immunotherapy Using Polyclonal Tregs + IL-2
Official title: A Phase 1 Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy With Interleukin-2 for the Treatment of Type 1 Diabetes
Acronym: TILT
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-31
Primary completion date: 2021-08-27
Completion date: 2021-08-27
Plan to share individual participant data: NO
Clinical trial NCT03371355: Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)
Sponsor: Akcea Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 105.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-12-21
Primary completion date: 2019-11-21
Completion date: 2020-02-24
Baseline population: Full Analysis Set (FAS) population included all participants who were randomized and received at least 1 dose of study drug.
Clinical trial NCT04968379: Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
Official title: An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 Year) With Iron Deficiency Anemia
Sponsor: American Regent, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Difficult to recruit and enroll patients for this study in a reasonable amount of time.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-21
Primary completion date: 2024-10-08
Completion date: 2024-12-12
Clinical trial NCT05136833: Evaluation of Efficacy and Safety of the Concomitant of RUTI® Immunotherapy With the Standard Treatment in TB Patients
Official title: A Phase IIb Study to Explore the Efficacy and Safety of the Concomitant Administration of RUTI® Immunotherapy With the Standard Treatment in Patients With TB
Acronym: CONSTAN
Sponsor: Archivel Farma S.L. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Covid-19 pandemia
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2022-06-30
Completion date: 2022-12-31
Clinical trial NCT04953052: A Randomized Study to Investigate the Effect of Intravenous Imatinib on the Amount of Oxygen in the Lungs and Blood of Adults With COVID-19 Needing Mechanical Ventilation and Supportive Care.
Official title: A Randomized, Double-blind, Multicentre 2-arm, Parallel-group, Placebo-controlled Study to Investigate the Efficacy and Safety of Intravenous Imatinib Mesylate in Reducing the Severity of Hypoxemic Respiratory Failure in Patients With Critical COVID-19 Receiving Standard of Care.
Acronym: IMPRESS COVID
Sponsor: Exvastat Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Number of moderate to severe ARDS patients hospitalised due to COVID19 diminishingly small. Not expected to recruit required minimum number of patients.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-14
Primary completion date: 2022-08-31
Completion date: 2022-11-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03469050: Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
Official title: Rifaximin Delayed Release (400 mg Tablet) for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. A Phase II, Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
Acronym: ROAD
Sponsor: Alfasigma S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Sponsor's decision
Enrollment: 193.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-02
Primary completion date: 2020-12-22
Completion date: 2020-12-22
Clinical trial NCT03830866: Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Official title: A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer
Acronym: CALLA
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 770.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-15
Primary completion date: 2022-01-20
Completion date: 2023-07-03
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT02853344: Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
Official title: A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 275.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-30
Primary completion date: 2021-02-05
Completion date: 2022-04-01
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04327310: Clinical Study of Meplazumab to Treat With Malaria
Official title: A Phase 1, 3 Part, Randomized, Placebo Controlled, Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of Meplazumab and to Assess Its Antimalarial Activity Against Plasmodium Falciparum in a Malaria Challenge Model in Healthy Subjects
Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The same drug has completed the phase I and II clinical trials for COVID-19
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-31
Primary completion date: 2023-12-31
Completion date: 2024-03-31
Clinical trial NCT03181893: A Study In Adults With Moderate To Severe Dermatomyositis
Official title: A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-23
Primary completion date: 2022-05-27
Completion date: 2022-11-28
Baseline population: The safety analysis population included all participants who had received at least 1 dose of study drug 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 NCT04534803: BCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST)
Official title: Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
Sponsor: Harvard Medical School (HMS and HSDM) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: At this time it has been decided by the study team the the study will no longer take place in the United States.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2022-05-31
Completion date: 2022-07-31
Plan to share individual participant data: NO