chufangao/CTO huggingface dataset:
Clinical trial NCT03678792: Comparison of Three Opioid Detoxification Treatment Regimens
Official title: Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Infeasible to conduct at this time.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-15
Primary completion date: 2020-09-30
Completion date: 2020-10-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03737110: Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis
Official title: Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis
Acronym: RHAPSODY
Sponsor: Kiniksa Pharmaceuticals International, plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-07
Primary completion date: 2020-05-29
Completion date: 2022-06-30
Baseline population: All participants entering the double-blind Randomized Withdrawal Treatment Period.
Plan to share individual participant data: NO
Clinical trial NCT02338999: Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
Official title: The Role of PPAR-Gamma Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-18
Primary completion date: 2020-07-14
Completion date: 2020-07-14
Clinical trial NCT04588792: Furosemide as Supportive Therapy for COVID-19 Respiratory Failure
Official title: Nebulized Furosemide for Pulmonary Inflammation in Intubated Patients With COVID-19 - A Phase 2/3 Study
Acronym: FaST-1
Sponsor: Queen's University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Lack of recruitment due to decline in critically ill Covid-19 patients
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-16
Primary completion date: 2023-02-01
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT04783766: Safety, Tolerability and Pharmacokinetics Study of CK-3773274
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects
Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-10
Primary completion date: 2021-08-05
Completion date: 2021-08-05
Clinical trial NCT00362219: Topical Morphine for Analgesia in Patients With Skin Grafts
Official title: Topical Morphine for Analgesia in Patients With Skin Grafts
Sponsor: Rambam Health Care Campus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: no patients were recrueted
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-01-31
Primary completion date: 2023-12-31
Completion date: 2024-12-31
Clinical trial NCT01888484: Study of Octanorm Subcutaneous IG in Patients With PID
Official title: Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases
Sponsor: Octapharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-03-31
Primary completion date: 2020-06-09
Completion date: 2020-06-09
Clinical trial NCT01940809: Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery
Official title: A Sequential Safety and Biomarker Study of BRAF-MEK Inhibition on the Immune Response in the Context of Combined CTLA-4 Blockade and PD-1 Blockade for BRAF Mutant Melanoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Inadequate accrual rate
Enrollment: 15.0 (ACTUAL)
Number of arms: 8.0
Start date: 2013-08-28
Primary completion date: 2020-07-17
Completion date: 2022-03-04
Clinical trial NCT04817345: Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor
Official title: Peripheral Blood Stem Cell Collection From Patients With Sickle Cell Disease (SCD) Using Plerixafor
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The safety and efficacy of plerixafor in adult and pediatric SCD patients was an unknown when we started. A lot more data from therapeutic trials is available. We feel that recruiting patients without a therapeutic option isn't ethically justifiable.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-04-30
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: YES
IPD sharing description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
IPD time frame: Data will be made available at the time of article publication.
IPD access criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Clinical trial NCT03619187: An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients
Official title: A Phase 3, Open-label, Multicenter Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients With Elevated Resting Heart Rate
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-02
Primary completion date: 2020-02-19
Completion date: 2020-02-19
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT04130282: VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine
Official title: A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Delays caused by Covid-19
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-27
Primary completion date: 2020-09-22
Completion date: 2020-09-22
Clinical trial NCT04163094: Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy
Official title: Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy
Acronym: OLIVIA
Sponsor: University Medical Center Groningen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Despite the extension of the original recruitment period, the target number of evaluable patients defined in the study protocol could not be reached and recruitment for the trial was stopped at that point of time.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-25
Primary completion date: 2023-06-26
Completion date: 2023-06-26
Plan to share individual participant data: NO
Clinical trial NCT03802994: Pneumococcal Conjugate Vaccine in Aging Renal Transplant
Official title: Immune Response to Pneumococcal Vaccination in Aging Renal Transplant Recipients
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Due to COVID pandemic further recruitment of subjects was unethical.
Enrollment: 57.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-11-01
Primary completion date: 2020-02-28
Completion date: 2020-02-28
Baseline population: In Groups 1, 3,4 and 5 2 individuals per group were enrolled but did not complete the study which affected parameters of all study objectives: pre- to post-antibody and opsonophagocytic responses, B cell analysis and inflammatory markers.
Limitations and caveats: Early termination leading to small numbers of enrolled subjects due to the COVID pandemic
Plan to share individual participant data: NO
Clinical trial NCT03211988: Entinostat Neuroendocrine (NE) Tumor
Official title: A Phase 2 Single-Arm Multicenter Study of Entinostat in Patients With Relapsed or Refractory Abdominal Neuroendocrine (NE) Tumors
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of funding and drug supply
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-23
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04809623: Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
Official title: A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)
Acronym: LYNX
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision to terminate study.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2022-10-18
Completion date: 2022-10-18
Baseline population: Safety population included all participants who received at least one dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT02278250: First in Human Study of M4344 in Participants With Advanced Solid Tumors
Official title: An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (Formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 97.0 (ACTUAL)
Number of arms: 18.0
Start date: 2015-01-26
Primary completion date: 2021-06-16
Completion date: 2021-09-24
Plan to share individual participant data: NO
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Clinical trial NCT05320094: A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Official title: An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-04-15
Primary completion date: 2022-09-11
Completion date: 2022-09-11
Clinical trial NCT02953327: Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau
Official title: Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau
Sponsor: Bandim Health Project (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-01
Primary completion date: 2017-06-15
Completion date: 2020-06-15
Clinical trial NCT03519308: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Official title: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The accrual goal could not be met and the drug manufacturer pulled support
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-29
Primary completion date: 2022-04-18
Completion date: 2022-04-18
Baseline population: Patients with resectable epithelial-subtype pancreatic cancer
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04334408: Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL
Official title: A Phase II Double-Blinded Placebo Controlled Individual Subject Stepped Wedge Clinical Trial Evaluating the Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding to support the trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05609045: A Phase 1, Randomised, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of RH109 as Booster
Official title: A Phase 1, Randomised, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of RH109 as Booster for Healthy Adults Who Have Received Homologous or Heterologous Vaccination With 3 Doses of COVID-19 Inactivated and/or mRNA Vaccine(s)
Sponsor: Wuhan Rhegen Biotechnology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: business strategy adjustment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-06-30
Primary completion date: 2023-08-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT04741074: Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
Official title: A RAndomized trIal Examining the Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy for Patients With Stage 4-5 CKD or Dialysis-dependent ESKD
Acronym: RAISE-KT
Sponsor: Geisinger Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-23
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Limitations and caveats: The study was terminated prematurely by the funder due to slow recruitment.
Plan to share individual participant data: YES
IPD time frame: Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
IPD access criteria: The deidentified IPD will be publicly available without restrictions.
Clinical trial NCT03652493: Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Official title: Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Acronym: PRO-CARBO
Sponsor: Centre Francois Baclesse (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: lack of efficacy
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-10
Primary completion date: 2021-04-27
Completion date: 2021-04-27
Plan to share individual participant data: NO
Clinical trial NCT05195827: Effect of PRM-125 on Ambulatory Blood Pressure
Official title: Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension
Sponsor: PRM Pharma, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-20
Primary completion date: 2022-09-30
Completion date: 2022-11-30
Plan to share individual participant data: NO
Clinical trial NCT01519960: A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Official title: A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 165.0 (ACTUAL)
Number of arms: 4.0
Start date: 2012-07-11
Primary completion date: 2015-07-09
Completion date: 2021-10-18
Clinical trial NCT03742154: Hollings Cancer Center Varenicline Sampling Study
Official title: A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 99.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-03
Primary completion date: 2020-04-06
Completion date: 2020-04-06
Plan to share individual participant data: NO
Clinical trial NCT04984993: Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Official title: A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period
Sponsor: Futura Medical Developments Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-14
Primary completion date: 2022-07-13
Completion date: 2022-07-13
Baseline population: Regional enrolment details are combined for both the male participants and their female partners.
Clinical trial NCT02528643: A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 165.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-09
Primary completion date: 2017-10-02
Completion date: 2021-02-09
Baseline population: Full analysis set (FAS) consisted of all randomized participants regardless of whether or not participants received study drug.
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.
Clinical trial NCT04057261: Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Official title: Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Acronym: Lirabolic
Sponsor: RWTH Aachen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: A study start is currently not foreseeable for organizational reasons. Due to the delays, research has also been focused on new compounds, which has reduced the interest in the potential results of the above-mentioned clinical trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-30
Primary completion date: 2022-08-31
Completion date: 2022-11-30
Clinical trial NCT02988973: A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia
Official title: A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 334.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-01-12
Primary completion date: 2019-09-13
Completion date: 2020-03-26
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.
Clinical trial NCT05016934: Evaluation of Safety and Immunogenicity of a Novel Vaccine for Prevention of Covid-19 in Adults Previously Immunized
Official title: Randomized Controlled-trial to Evaluate Safety, Immunogenicity and Efficacy of a Vaccine Composed of a Recombinant S1 Antigen for Prevention of Covid-19 in Adults Previously Fully Immunized With Other Vaccines
Sponsor: Hospital do Coracao (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: At collaborator's request
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-01
Primary completion date: 2022-03-04
Completion date: 2022-04-20
Plan to share individual participant data: NO