protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04297917 | 6.3.4 | Clinic Visit: Days 28, 56 (Cohorts 1-4) and 168 (End of Study Visit Cohorts 1-4) | 6.3.4 Clinic Visit: Days 28, 56 (Cohorts 1-4) and 168 (End of Study Visit Cohorts 1-4) - A urine pregnancy test will be performed - A symptom-directed physical examination will be performed if required - Vital signs (pulse rate, blood pressure and temperature) will be measured - Blood samples will be taken for haematol... | [] |
NCT04297917 | 6.3.5 | Clinic Visit: Day 84 (including End of Study Visit Cohorts 5 and 6) | 6.3.5 Clinic Visit: Day 84 (including End of Study Visit Cohorts 5 and 6) - A symptom-directed physical examination will be performed if required - Vital signs (pulse rate, blood pressure and temperature) will be measured - Blood samples will be taken for haematology (including PT/INR and aPTT), biochemistry and LFTs -... | [] |
NCT04297917 | 6.4 | Assessments at Unscheduled Visits | 6.4 Assessments at Unscheduled Visits Unscheduled visits may be required according to the participant's condition; assessments performed will be recorded in the eCRF. | [] |
NCT04297917 | 6.5 | Participant Discontinuation | 6.5 Participant Discontinuation Participants have the right to withdraw from the study at any time for any reason, including their future care. The Investigator should however try to find out why a participant withdraws from the study and document the reason for withdrawal in the source documents and eCRF. If there is ... | [] |
NCT04297917 | 7 | DETAIL OF STUDY ASSESSMENTS | 7 DETAIL OF STUDY ASSESSMENTS | [] |
NCT04297917 | 7.1 | Demographic and Baseline Assessments | 7.1 Demographic and Baseline Assessments The following will be collected at screening to determine eligibility and baseline status of the participant. Baseline safety assessments will also be performed as detailed in Section [7.3.](#page-54-3) | [] |
NCT04297917 | 7.1.1 | Demographic Data and Baseline Variables | 7.1.1 Demographic Data and Baseline Variables Demographic data will include age, gender and race/ethnicity, smoking history, use of alcohol and drugs of abuse. Height and weight will also be measured. | [] |
NCT04297917 | 7.1.2 | Medical and Disease History | 7.1.2 Medical and Disease History Disease history (including date of diagnosis) and any allergies or other clinically significant diseases and surgeries will be recorded. | [] |
NCT04297917 | 7.1.3 | Prior Medications and Therapies | 7.1.3 Prior Medications and Therapies All prior therapies and procedures will be recorded. All other prior medications (e.g. prescription drugs, over the counter drugs, herbal/homeopathic remedies, nutritional supplements) used by the participant in the 28 days before the screening visit will also be recorded (see Sect... | [] |
NCT04297917 | 7.1.4 | Laboratory Eligibility Tests | 7.1.4 Laboratory Eligibility Tests Haematology, biochemistry, LFTs and viral serology blood tests and urinalysis will be performed at screening for all participants. All of these samples will be analysed at the local laboratory in the hospital. Results from tests must be reviewed by the Investigator (or a designee who ... | [
"Haematology",
"Biochemistry and Liver Function Tests",
"HIV, HBV, HCV and HDV Diagnostic Testing",
"Urinalysis"
] |
NCT04297917 | 7.1.5 | Urine Pregnancy Test | 7.1.5 Urine Pregnancy Test A urine pregnancy test will be performed in female participants of childbearing potential at screening and confirmed to be negative pre-vaccination on Day 0, as per local standard procedures and at each of the timepoints according to [Table 2.](#page-47-0) | [] |
NCT04297917 | 7.2 | Immunogenicity Assessments | 7.2 Immunogenicity Assessments Immunogenicity samples (PBMCs) will be taken for planned and potential exploratory analyses at each of the timepoints according to [Table 2.](#page-47-0) Immunogenicity studies will include (but are not limited to) analysis of samples ex vivo by multiparameter flow cytometry (including Me... | [] |
NCT04297917 | 7.2.1 | Secondary Outcomes in Blood Samples | 7.2.1 Secondary Outcomes in Blood Samples Peripheral blood mononuclear cells will be isolated from blood samples taken at each of the timepoints according to [Table 2,](#page-47-0) and tested for recognition of overlapping HBV peptide pools using ICS for multiple cytokines including, and not limited to IFN-γ, and will ... | [] |
NCT04297917 | 7.2.2 | Exploratory Analysis | 7.2.2 Exploratory Analysis
Exploratory Analysis in Blood Samples HBV-specific CD4+ and T cell subsets within PBMC will be further defined by phenotypic markers of activation, differentiation and memory. Peripheral blood mononuclear cells will also be used in IFN-γ ELISpot assays to determine the breadth of HBV-specifi... | [
"Exploratory Analysis in Blood Samples",
"Exploratory Analysis in Liver Fine Needle Aspirates"
] |
NCT04297917 | 7.3 | Safety Assessments | 7.3 Safety Assessments | [] |
NCT04297917 | 7.3.1 | Adverse Events | 7.3.1 Adverse Events Recording and reporting of adverse events is described in detail in Section [8.2.](#page-57-3)
Solicited Adverse Events Solicited adverse events are events the participant is specifically asked about. These adverse events are commonly observed soon after receipt of vaccines and relate to local and... | [
"Solicited Adverse Events",
"Unsolicited Adverse Events"
] |
NCT04297917 | 7.3.2 | Laboratory Safety Tests | 7.3.2 Laboratory Safety Tests Laboratory safety tests will be performed at each of the timepoints according to [Table 2,](#page-47-0) as per Sections [7.1.4.1](#page-52-6) and [7.1.4.2.](#page-52-7) Extra laboratory safety tests may be performed if the Investigator deems them to be necessary to fully evaluate an advers... | [] |
NCT04297917 | 7.3.3 | Physical Examination | 7.3.3 Physical Examination A skin, respiratory, cardiovascular, abdominal and lymphatic system examination will be performed at screening and pre-vaccination on Day 0. A symptom-directed physical examination will be performed at all other clinic visits if required. Results will be recorded as normal, abnormal and not c... | [] |
NCT04297917 | 7.3.4 | Vital Signs | 7.3.4 Vital Signs Vital signs will be performed at screening, pre-vaccination and post-vaccination (at the end of the observation period) at the vaccination visit, at all visits during the follow-up and the end of study visit. At each timepoint blood pressure, pulse rate and oral temperature, will be measured after the... | [] |
NCT04297917 | 8 | SAFETY MANAGEMENT | 8 SAFETY MANAGEMENT | [] |
NCT04297917 | 8.1 | Responsibilities for Ensuring the Safety of Study Participants | 8.1 Responsibilities for Ensuring the Safety of Study Participants The national Competent Authority, the study Sponsor, the Institution through which the research is performed, and all members of the Investigator's study team share responsibility for ensuring that participants in this study are exposed to the least pos... | [] |
NCT04297917 | 8.1.1 | Investigator | 8.1.1 Investigator The Investigator has a personal responsibility to closely monitor study participants and an inherent authority to take whatever measures necessary to ensure their safety. The Investigator may delay a participant's study vaccine administration or pause study vaccine administration in the whole study i... | [] |
NCT04297917 | 8.1.2 | Study Sponsor | 8.1.2 Study Sponsor The Sponsor also has an institutional responsibility to ensure participant safety. This responsibility is vested in the local Medical Monitor and an SMC. | [] |
NCT04297917 | 8.1.3 | Local Medical Monitor | 8.1.3 Local Medical Monitor The local Medical Monitor (LMM) is the Sponsor's medical representative. The LMM reviews safety information collected throughout the study. The LMM can add another causality to the Investigator's causality assessment, however the causality assessment given by the Investigator must not be dow... | [] |
NCT04297917 | 8.1.4 | Safety Monitoring Committee | 8.1.4 Safety Monitoring Committee The SMC will constitute the Sponsor Representative, the Principal Investigator at each centre, the local Medical Monitor and the Chief Investigator. The SMC will operate in accordance with the study-specific charter, which will be agreed prior to the start of enrolment. An SMC will be ... | [] |
NCT04297917 | 8.1.5 | Data Monitoring Committee | 8.1.5 Data Monitoring Committee A DMC will be appointed to perform unscheduled reviews of the available data including safety and tolerability study data and make recommendations concerning the continuation, modification, or termination of the study if one of the study stopping or holding rules defined in Section [3.1.... | [] |
NCT04297917 | 8.1.6 | Research Ethics Committee | 8.1.6 Research Ethics Committee The HRA/REC has institutional responsibility for the safety of participants in clinical studies. The HRA/REC has the authority to terminate, suspend or require changes to a clinical study. | [] |
NCT04297917 | 8.1.7 | Competent Authority | 8.1.7 Competent Authority Since the Competent Authority receives all expedited safety reports for the study it also has the authority to terminate, suspend or require changes to a clinical study. | [] |
NCT04297917 | 8.2 | Adverse Events | 8.2 Adverse Events | [] |
NCT04297917 | 8.2.1 | Definitions | 8.2.1 Definitions
Adverse Event An adverse event is: - Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment - An adverse event can therefore be any unfavourable and ... | [
"Adverse Event",
"Adverse Reaction",
"Serious Adverse Event",
"Suspected Unexpected Serious Adverse Reaction"
] |
NCT04297917 | 8.2.2 | Study Reporting Period for Adverse Events | 8.2.2 Study Reporting Period for Adverse Events The reporting period for all adverse events begins on the date the informed consent is signed. Solicited adverse events are recorded in the eDiary up to 3 days post-vaccination. All other events are recorded in the eCRF up until Day 28. All SAEs and or Adverse events of s... | [] |
NCT04297917 | 8.2.3 | Recording and Assessment of Adverse Events by the Investigator | 8.2.3 Recording and Assessment of Adverse Events by the Investigator Solicited adverse events are recorded in the eDiary up to 3 days post-vaccination. All other adverse events are recorded in the eCRF up to until Day 28. All adverse events, both those observed by study team members and those spontaneously reported by ... | [
"Assessment of Severity",
"Assessment of Relationship",
"\"Is there a reasonable possibility that the adverse event may have been caused by the study vaccine?\"",
"Action Taken with Study Vaccine",
"Assessment of Outcome"
] |
NCT04297917 | 8.2.4 | Reporting Requirements and Procedures for Serious Adverse Events | 8.2.4 Reporting Requirements and Procedures for Serious Adverse Events All SAEs are reported to the Sponsor for the entire study period. Suspected, unexpected, serious adverse reactions are reported even after the study is over, if the Sponsor, local Medical Monitor or Principal Investigator becomes aware of them. The ... | [
"Follow-up Information on an SAE",
"Required Follow-up for SAEs",
"Medical Review and Reporting by the Sponsor",
"Sponsor Responsibility for Expedited Safety Reports"
] |
NCT04297917 | 8.2.5 | Follow-up of Participants after Adverse Events | 8.2.5 Follow-up of Participants after Adverse Events
Investigator Follow-up Treatment of any adverse events will be determined by the Investigator using his/her best medical judgment and according to current clinical practice guidelines. All applied measures as well as follow-up will be recorded in the appropriate eCR... | [
"Investigator Follow-up"
] |
NCT04297917 | 8.2.6 | Post-study Adverse Events | 8.2.6 Post-study Adverse Events At the final study visit, the Investigator should instruct each participant to report to the Investigator any subsequent adverse events that the participant's personal physician believes could be related to study vaccine or study procedures. The Investigator should notify the Sponsor (or... | [] |
NCT04297917 | 8.3 | Other Events of Special Interest | 8.3 Other Events of Special Interest Adverse events of special interest represent a subset of adverse events that include autoimmune diseases and other systemic disorders of interest which could potentially have an autoimmune aetiology. The Investigator should use clinical and scientific judgment in deciding whether ot... | [] |
NCT04297917 | 8.4 | Overdoses or Incorrect Administration | 8.4 Overdoses or Incorrect Administration Study vaccine overdose is the accidental or intentional use of the study vaccine in an amount higher than the dose being studied. An overdose or incorrect administration of study vaccine is not an adverse event unless it results in untoward medical effects: - Any study vaccine ... | [] |
NCT04297917 | 8.5 | Management of Pregnancy | 8.5 Management of Pregnancy | [] |
NCT04297917 | 8.5.1 | Notification and Follow-up | 8.5.1 Notification and Follow-up Any pregnancies occurring during the study or within 6 months after the last dose of study vaccine must be reported to the Sponsor (or designee) within 24 hours of knowledge of the event. The paper pregnancy form should be completed with all information known at the time and scanned and... | [] |
NCT04297917 | 8.5.2 | Outcome | 8.5.2 Outcome Additional information on the course and outcome of the pregnancy should be provided to the Sponsor (or designee) when available using the pregnancy report form. The following pregnancy outcomes will be considered to be SAEs and should be reported according to the procedure in Section [8.2.4.](#page-61-2)... | [] |
NCT04297917 | 9 | DATA QUALITY ASSURANCE AND QUALITY CONTROL | 9 DATA QUALITY ASSURANCE AND QUALITY CONTROL | [] |
NCT04297917 | 9.1 | Protocol Violations and Deviations | 9.1 Protocol Violations and Deviations Major protocol deviations are defined as those that result in harm to the study participants or significantly affect the scientific value of the reported results of the study. Other deviations will be considered minor. Protocol deviations will be recorded on the source documents a... | [] |
NCT04297917 | 9.2 | Monitoring and Source Document Verification | 9.2 Monitoring and Source Document Verification The Sponsor will arrange for the study to be monitored in accordance with the principles of ICH GCP [\[34\]](#page-82-1). The frequency of monitoring visits will be determined by the rate of participant recruitment. The following are examples of items that will be reviewe... | [] |
NCT04297917 | 9.3 | Data Management and Coding | 9.3 Data Management and Coding Data for each participant will be recorded on an eCRF. Data collection must be completed for each participant who signs an informed consent form and receives at least one dose of study vaccine. Electronic CRFs will be designed and produced by the Sponsor (or designee) and should be comple... | [] |
NCT04297917 | 10 | STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN | 10 STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN | [] |
NCT04297917 | 10.1 | Sample Size Determination | 10.1 Sample Size Determination No formal sample size calculation for cohorts 1 to 4 was performed and sample size is based upon feasibility considerations. The chosen number of participants is considered sufficient to meet the objectives for the study. The sample size for cohorts 5 and 6 is based on the ELISpot results... | [] |
NCT04297917 | 10.2 | Statistical and Analytical Plans | 10.2 Statistical and Analytical Plans This section presents a summary of the planned statistical analyses. Full details of the analysis will be described in the SAP that will be approved before database lock. Any analysis that deviates from the SAP will be documented and justified in the clinical study report. The comp... | [] |
NCT04297917 | 10.2.1 | Analysis Sets | 10.2.1 Analysis Sets - The intent-to-treat/safety analysis set will consist of all participants who received at least one vaccination (data will be summarised according to the vaccination actually received) - The per-protocol analysis set will consist of all participants in the safety analysis set who received the corr... | [] |
NCT04297917 | 10.2.2 | Study Analyses | 10.2.2 Study Analyses
General Principles The majority of the analysis will be descriptive in nature. Unless stated otherwise, continuous variables will be summarised using descriptive statistics (number of participants, mean, standard deviation, median, minimum and maximum values) and the number and percentage of part... | [
"General Principles",
"Disposition",
"Protocol Deviations",
"Demographics and Baseline Data",
"Immunogenicity Analyses",
"Safety Data"
] |
NCT04297917 | 10.2.2.6.1 | Adverse Events | 10.2.2.6.1 Adverse Events All adverse events will be listed, including the verbatim description and MedDRA preferred terms and system organ class (SOC). Treatment emergent adverse events (TEAEs) are defined as those occurring after the study vaccine administration. Vaccitech Ltd CONFIDENTIAL Page 69 of 118  will be assigned to laboratory safety values where applicable. Laboratory results in reported units and standard international (SI) units will be listed, including high and low flags, severity grades where applicabl... | [] |
NCT04297917 | 10.2.2.6.3 | Vital Signs | 10.2.2.6.3 Vital Signs Absolute and change from baseline vital sign results, including the worst change for each variable for each participant will be summarised using descriptive statistics. Treatment emergent out of range results with the corresponding normal ranges, baseline results and clinical significance will be... | [] |
NCT04297917 | 10.2.2.6.4 | Physical Examination | 10.2.2.6.4 Physical Examination Treatment emergent abnormal physical examination with the corresponding clinical significance will be listed. Shift tables will be used to show changes in physical examination status from baseline at each timepoint and the worst shift in each participant will be included. | [] |
NCT04297917 | 10.2.3 | Interim Analyses | 10.2.3 Interim Analyses No interim analyses are planned.  | [] |
NCT04297917 | 10.2.4 | Handling Missing, Unused or Spurious Data | 10.2.4 Handling Missing, Unused or Spurious Data The SAP will describe and account for the occurrence of and extent of missing data, and its possible impact on the study analysis.  | [] |
NCT04297917 | 11 | STUDY DOCUMENTATION, INSPECTIONS AND RECORD KEEPING | 11 STUDY DOCUMENTATION, INSPECTIONS AND RECORD KEEPING | [] |
NCT04297917 | 11.1 | Study Documentation | 11.1 Study Documentation The Investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should contain all essential documents required by ICH GCP [\[34\]](#page-82-1) and include: - 1. ISF (e.g. prot... | [] |
NCT04297917 | 11.2 | Audits and Study Centre Inspections | 11.2 Audits and Study Centre Inspections Authorised personnel from Competent Authorities and the Sponsor quality assurance function may carry out inspections and audits respectively. The purpose of an audit or inspection is to ensure that ethical, regulatory and quality requirements are fulfilled in Sponsor studies. If... | [] |
NCT04297917 | 11.3 | Retention of Records | 11.3 Retention of Records Records and documents pertaining to the conduct of this study and the distribution of study vaccine, including eCRFs, informed consent forms, laboratory safety test results and study vaccine inventory and accountability records, must be retained by the Investigator for at least 15 years after ... | [] |
NCT04297917 | 12 | FINANCE AND INSURANCE | 12 FINANCE AND INSURANCE Financial arrangements are detailed in the Investigator Agreement between the Sponsor and Investigator. Details of the Sponsor's arrangement for clinical study insurance to provide for compensation to participant for any claim for bodily injury or death arising from participation in the clinica... | [] |
NCT04297917 | 13 | ETHICAL AND REGULATORY CONSIDERATIONS | 13 ETHICAL AND REGULATORY CONSIDERATIONS | [] |
NCT04297917 | 13.1 | Local Regulations/Declaration of Helsinki | 13.1 Local Regulations/Declaration of Helsinki The Investigator will ensure that this study is conducted in full conformance with the protocol and the principles of the "Declaration of Helsinki" [\[38\]](#page-82-5) or with the laws and regulations of the country in which the research is conducted, whichever affords th... | [] |
NCT04297917 | 13.2 | Competent Authority Approval | 13.2 Competent Authority Approval The study will not commence before approval from the Competent Authority been granted according to local requirements. The Sponsor (or designee) will be responsible for the preparation, submission and confirmation of receipt of any Competent Authority approvals required prior to releas... | [] |
NCT04297917 | 13.3 | Research Ethics Committee Approval | 13.3 Research Ethics Committee Approval The Investigator will be responsible for submitting submit all documents required by the HRA/REC e.g. this protocol, the informed consent form relevant supporting information and all types of study specific participant recruitment information (including advertisements) and any ot... | [] |
NCT04297917 | 13.4 | Informed Consent | 13.4 Informed Consent It is the responsibility of the Investigator to obtain written informed consent from participants prior to conducting any study related procedures. All consent documentation must be in accordance with applicable regulations and ICH GCP [\[34\]](#page-82-1). Each participant is requested to Vaccite... | [] |
NCT04297917 | 13.5 | Protocol Amendments | 13.5 Protocol Amendments The protocol (and other supporting documents that have received approval before the start of the study e.g. informed consent form) may not be modified without written approval from the Sponsor. In the event that an amendment to the protocol (and/or supporting documents) is required, it will be ... | [] |
NCT04297917 | 13.6 | Confidentiality of Study Documents and Participant Records | 13.6 Confidentiality of Study Documents and Participant Records The Investigator must ensure that participant's anonymity will be maintained and that their identities are protected from unauthorised parties. The Sponsor (or designee) will maintain confidentiality standards by assigning a unique coded identification num... | [] |
NCT04297917 | 14 | STUDY COMPLETION | 14 STUDY COMPLETION All materials or supplies provided by the Sponsor will be returned to the Sponsor upon study completion. The Investigator will notify the HRA/REC when the study has been completed. The study will be considered complete when the last participant completes their final follow-up visit and all the data ... | [] |
NCT04297917 | 15 | PUBLICATION OF DATA | 15 PUBLICATION OF DATA The final study report will be made available to the Investigator for purposes of publications. The Investigator and study team must send all manuscripts, abstracts, and presentations using data from this study to the Sponsor for review prior to their submission. The Sponsor reserves the right to... | [] |
NCT04297917 | 16 | REFERENCES | 16 REFERENCES - 1. World Health Organization. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. March 2015. Available at: [https://www.who.int/hepatitis/topics/hepatitis-b/en/.](https://www.who.int/hepatitis/topics/hepatitis-b/en/) Last accessed on 11 July 2019. - 2. Cesar... | [
"Appendix 1 Toxicity Table for Clinical and Laboratory Abnormalities",
"Appendix 2 Details of Changes Made in Protocol Amendments",
"Details of Changes Made in Protocol Amendment 8 (Protocol Version 9.0, 24 Nov 21)",
"1.5.1 Rationale for Investigation of Dosing Interval With Respect to COVID-19 Vaccines",
"... |
NCT04310579 | 1 | List of Abbreviations | 1. List of Abbreviations | Abbreviation | Definition | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04310579 | 2 | Introduction | 2. Introduction | [] |
NCT04310579 | 2.1 | General Background | 2.1. General Background A well-known and potentially fatal adverse reaction associated with opioid administration, particularly in the scenario of misuse, abuse, or when coadministered with certain other drugs is that people 'stop breathing'. Research suggests this is caused by a reduced respiratory response to counter... | [] |
NCT04310579 | 2.2 | Lead-in Reproducibility Assessment | 2.2. Lead-in Reproducibility Assessment The objective ofthe lead-in reproducibility assessment is to determine the variability associated with the rebreathing method used to evaluate the ventilatory response to hypercapnia. Up to ten healthy volunteers will be enrolled. Initially data will be collected from up to 5 sub... | [] |
NCT04310579 | 2.3 | Part 1: Oxycodone and Midazolam | 2.3. Part 1: Oxycodone and Midazolam The objective of Part 1 is to assess the primary and secondary endpoints for oxycodone and midazolam. This study will be a 4-period randomized crossover study with approximately 20 healthy volunteers. Part 1 will also inform dose selection for Part 2. Interim analyses will be perfor... | [
"Primary Endpoint",
"Secondary Endpoints",
"Exploratory Endpoints",
"o Terminal half-life (i)"
] |
NCT04310579 | 2.4 | Part 2: Coadministration of Oxycodone with Paroxetine and Quetiapine | 2.4. Part 2: Coadministration of Oxycodone with Paroxetine and Quetiapine 'The objective of Part 2 is to assess the primary and secondary endpoints for paroxetine and quetiapine with reference to oxycodone. This study will be a 3-period randomized " crossover study iri approximately 20 healthy volunteers.
Primary Endp... | [
"Primary Endpoint",
"Secondary Endpoints ,",
"Exploratory Endpoints",
"o Visual analogue scale"
] |
NCT04310579 | 3 | Study Objectives | 3. Study Objectives | [] |
NCT04310579 | 3.1 | Primary Objectives | 3.1. Primary Objectives 'The primary objective is to study whether combining psychotropic drugs (paroxetine, quetiapine and midazolam) with an opioid (oxycodone) decreases the ventilatory response to hypercapnia compared to an opioid alone. | [] |
NCT04310579 | 3.2 | Secondary Objective(s) | 3.2. Secondary Objective(s) Secondary objectives include the following: - e To study whether each psychotropic drug (paroxetine, quetiapine, or midazolam) affects the pharmacokinetics of oxycodone. - To study whether each drug (oxycodone, paroxetine, quetiapine, or midazolam) decreases the ventilatory response to hyper... | [] |
NCT04310579 | 3.3 | Exploratory Objectives | 3.3. Exploratory Objectives Exploratory objectives include the following: - \ To study whether there is a direct pharmacodynamic interaction between each psychotropic drug and oxycodone. - \ To summarize additional pharmacokinetic parameters and pharmacodynamic measures collected during the study. | [] |
NCT04310579 | 4 | Investigational Plan | 4. Investigational Plan | [] |
NCT04310579 | 4.1 | Study Design | 4.1. Study Design | [] |
NCT04310579 | 4.1.1 | Lead-in Reproducibility Assessment | 4.1.1 Lead-in Reproducibility Assessment 'The lead-in reproducibility assessment will have up to 10 healthy volunteer participants. Up to five participants will be enrolled, and data analysis will be performed. If reproducibility is acceptable after the first analysis, additional lead-in cohorts may not be needed. If a... | [] |
NCT04310579 | 4.1.2 | Part1 | 4.1.2 Part1 The study Part 1 will assess the primary and secondary endpoints for oxycodone and midazolam and will inform oxycodone dose selection for study Part 2. The study will be a 4-period randomized crossover study with up to 20 healthy volunteer participants with the following design: Table 4-1 Part 1 Study Desig... | [] |
NCT04310579 | 4.13 | Part2 | 4.13 Part2 'The study Part 2 will assess the primary and secondary endpoints for paroxetine and quetiapine with reference to oxycodone. The study will be a 3-period randomized crossover study in approximately 20 healthy volunteer participants. Each treatment period will have 5 days of dosing followed by 7 days of washo... | [] |
NCT04310579 | 4.14 | Common Procedures | 4.14 Common Procedures 'To maintain the study blind, subjects will be blindfolded during study drug administration. The rebreathing analysis will be blinded to treatment, time, and study day/subject identifiers. At the study clinic (Spaulding Clinical Research unit in West Bend, Wisconsin), subjects will be screened fo... | [] |
NCT04310579 | 4.1.5 | Dosing Schedule | 4.1.5 Dosing Schedule | [] |
NCT04310579 | 4151 | Partl | 4151 Partl On day I of each period, subjects will receive one of the following treatments: - « Oral oxycodone 10 mg and placebo IV - o Oral placebo and 0.0375 mg/kg midazolam IV - « Oral oxycodone 10 mg and 0.0375 mg/kg midazolam IV - \ Oral placebo and placebo [V Oxycodone will be administered as 2 X § mg immediate re... | [] |
NCT04310579 | 4152 | Part2 - | 4152 Part2 - For Part 2, subjects will complete each of the 3 different treatments (Table 4-4, E-G) and will receive the following drugs alone or in combination: - Oxycodone (2-3 X Smg tablets depending on findings from Part 1) of cach period - o Paroxetine 40 mg tablets on days 1,2, 3, 4, and § - Quetiapine 50 mg tabl... | [
"4.1.6 Risk/Benefit",
"4.2. Selection of Study Population",
"4.2.1 Inclusion Criteria",
"4.2.2 Exclusion Criteria",
"4.3. Screening Failures",
"4.4, Termination of Study or Investigational Site",
"4.4.1 Criteria for Termination of the Study",
"4.4.2 Criteria for Termination of Invesi ational Site",
... |
NCT04310579 | 4752 | Specimen Handling | 4752 Specimen Handling A buffy coat from each study participant will be used for exploratory genomic analyses. On the specified collection day/time (see Table 8-1), 5 mL of whole blood sample will be processed for plasma and the upper plasma phase will be transferred to a new sterile tube without disturbing the interme... | [
"4.7.6 Safety Assessments",
"4.7.6.1 Adverse Events",
"4.7.6.1.1 Adverse Event Definitions",
"4.7.6.1.2 Adverse Event Reporting",
"4 .1.3 Assessment of Severity",
"4.7.6.1.4 Assessment of Causality v",
"4.7.6.1.5 Pregnancy",
"4.762 Clinical Laboratory Tests",
"4.763 Vital Sign Measurements",
"4.7.... |
NCT04310579 | 4832 | Midazolam | 4832 Midazolam 'The initial dose selected for midazolam is 0.0375 mg/kg IV. If required based on the dose escalation study in Part 1 (see Section 4.8), the dose will be increased to 0.075 mg/kg IV. Midazolam dose selection is based on previous published results where midazolam was administered alone or in combination w... | [
"'4.8.3.3 Paroxetine ."
] |
NCT04310579 | 4834 | Quetiapine | 4834 Quetiapine The dose selected for quetiapine is 50 mg BID on Day 1, 100 mg BID on Day 2, 150 mg BID on Days 3, 200 mg BID on Day 4 and 200 mg QD on Day 5. Quetiapine dose selection was based on approved product labeling for BipolarI Disorder, Mania.
4.83.5 Ondansetron The dose selected for ondansetron is 4 mg oral... | [
"4.83.5 Ondansetron",
"4.83.6 Naloxone",
"4.83.7 Flumazenil",
"4.8.4 Method of Assigning Subjects to Treatment Sequence",
"4.84.1 Randomization Process",
"4.8.5 Identity of Study Drugs",
"4.8.6 Management of Clinical Supplies",
"4386.1 Study Drug Packaging and Storage"
] |
NCT04310579 | 4862 | Study Drug Accountability | 4862 Study Drug Accountability Good clinical documentation practices will be employed to record the receipt, storage conditions, accountability, and use or return ofthe study drug. The study drug will be stored in a secure location with access to the study personnel who will be managing the storage, dispensing, and acc... | [
"4.8.7 Blinding",
"4.8.7.1 Breaking the Blind",
"4.88 Treatment Compliance",
"4.8.9 Prior and Concomitant Medications",
"4.8.10 Subject Restrictions",
"4.9. Statistical Methods",
"4.9.1 Sample Size",
"49.1.1 Lead-in Reproducibility Assessment s",
"49.12 Partl",
"49.1.3 Part2",
"4.9.2 Analysis Po... |
NCT04310579 | 4992 | Pupillometry Analyses | 4992 Pupillometry Analyses Maximum pupil diameter before constriction and dynamic pupillary measurements after a light stimulus will be measured before and after each Read rebreathing assessment in both eyes. These parameters will be summarized using descriptive statistics, and time courses summaries of both scores wil... | [] |
NCT04310579 | 4993 | Sedation Scores Analyses | 4993 Sedation Scores Analyses - Ramsay Sedation Scale is an obiserver-based assessment of sedation that will be collected for each subject as during the relaxation period of each Read Rebreathing procedure. In addition, subjects will be asked to provide their own assessment of sedation using the Visual Analog Scale dur... | [
"4. .4 Genomic Analyses",
"4.9.9.5 Sex Hormone Analyses",
"4.9.10 Safety Analyses",
"4.9.10.1 Adverse Events",
"4.9.10.2 Clinical Laboratory Tests",
"4.9.10.3 Vital Sign Measurements",
"4.9.10.4 Pulse Oximetry and Telemetry",
"4.9.10.5 Safety 12-lead Electrocardiograms",
"4.9.10.6 Physical Examinati... |
NCT04315298 | 1 | INTRODUCTION | 1. INTRODUCTION The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel enveloped RNA betacoronavirus that emerged in December 2019 in Wuhan, China. The term COVID-19 is the disease caused by SARS-CoV-2 with symptoms that manifest a median of 5 days and up to 14 days after infection. The most freque... | [
"Study 6R88-COV-2040"
] |
NCT04315298 | 2 | STUDY OBJECTIVES | 2. STUDY OBJECTIVES | [] |
NCT04315298 | 2.1 | Primary Objective | 2.1. Primary Objective
Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata.
Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy... | [
"Phase 2:",
"Phase 3 Cohort 1:",
"Phase 3 Cohort 2:"
] |
NCT04315298 | 2.2 | Secondary Objectives | 2.2. Secondary Objectives
Phase 2: The secondary efficacy objectives of the study are to: - 1. Evaluate the clinical efficacy of sarilumab compared to the control arm in all disease severity levels and by clinical severity - 2. Evaluate the clinical efficacy of sarilumab compared to the control arm by baseline IL-6 le... | [
"Phase 2:",
"Phase 3",
"Phase 3 Cohort 1:",
"Phase 3 Cohort 2:",
"Phase 2 and Phase 3:",
"Safety"
] |
NCT04315298 | 2.3 | Exploratory Objectives | 2.3. Exploratory Objectives
Phase 2 and Phase 3: The exploratory objectives of the study are to: - 1. Evaluate the virologic changes in the treatment arms compared to the control arm as assessed by: - Percent of patients with SARS-COV-2 detectable in oropharyngeal (OP) or nasopharyngeal (NP) sample - Quantitative SARS... | [
"Phase 2 and Phase 3:",
"Phase 3"
] |
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