protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT04870606 | 6.5.3 | Treatment Blinding | 6.5.3 Treatment Blinding This is a double-blinded study. Neither subjects, nor investigators, nor the Sponsor study team will be aware of treatment assignments prior to the final data base lock at the conclusion of the study. Unblinding procedures for this study - Emergency unblinding for AEs may be performed through t... | [] |
NCT04870606 | 6.6 | Study Treatment Supply | 6.6 Study Treatment Supply First supply of study supplies plus the study drugs will be shipped to sites within 2 weeks before site initiation visit. Subsequent supplies will be provided upon sites request or automatically initiated via IWRS, which may be changed per local guidance and situation. The site needs to proac... | [] |
NCT04870606 | 6.6.1 | Study Treatment Preparation and Dispensation | 6.6.1 Study Treatment Preparation and Dispensation The investigator or designee must confirm appropriate temperature conditions (if applicable) have been maintained during transit for all study intervention received and any discrepancies are reported and resolved before use of the study intervention. Only subjects enro... | [] |
NCT04870606 | 6.6.2 | Study Treatment Packaging and Labeling | 6.6.2 Study Treatment Packaging and Labeling GT0918 is an AR antagonist (MW 517.5 g/mol). The dosage form for clinical research is a 100 mg tablet weighing 320 mg per tablet. The 100 mg tablet is circular in shape with 10 mm in diameter. The color is light yellowish. The drug product tablets are packaged in PTP aluminu... | [] |
NCT04870606 | 6.6.3 | Drug Supply and Storage | 6.6.3 Drug Supply and Storage The recommended storage conditions for GT0918 tablets are room temperature with a shelf-life of 2 years. All drug supplies will be provided by the Sponsor or CRO. Study treatments must be received by designated personnel at the study site, handled and stored safely and properly, and kept i... | [] |
NCT04870606 | 6.6.4 | Study Treatment Compliance and Accountability | 6.6.4 Study Treatment Compliance and Accountability The investigation site will maintain records of study drug delivered to the study site; the inventory at the site; the distribution to and use by each subject; and the return of study drug to the Sponsor for storage and/or disposal if applicable. These records should ... | [] |
NCT04870606 | 6.6.5 | Disposal and Destruction | 6.6.5 Disposal and Destruction Study drugs will not be returned to the Sponsor or destroyed at the clinical site until accountability has been fully determined. After the study treatment period has ended or as appropriate over the course of the study after study product accountability has been performed; used or unused... | [] |
NCT04870606 | 7 | VISIT SCHEDULE AND ASSESSMENTS | 7 VISIT SCHEDULE AND ASSESSMENTS | [] |
NCT04870606 | 7.1 | Study Flow and Visit Schedule | 7.1 Study Flow and Visit Schedule This study contains up to 1-day screening visit (D-1), 14 days treatment (D1-D14), additional 28 days safety follow-up period (D15-D42). [See the SoA](#page-23-1) | [] |
NCT04870606 | 7.1.1 | Screening | 7.1.1 Screening After signing the study informed consent, the screening assessments will be done within 1 day prior to randomization (See SoA). Re-screening is not allowed in this study. | [] |
NCT04870606 | 7.1.1.1 | Eligibility Screening | 7.1.1.1 Eligibility Screening In order to determine and conform the eligibility of the subject, once all screening procedures are completed, an eligibility checklist must be completed via IRT by the investigator or designee prior to randomization. Please refer and comply with detailed guidelines in the IRT manual. | [] |
NCT04870606 | 7.1.1.2 | Information to Be Collected on Screening Failures | 7.1.1.2 Information to Be Collected on Screening Failures A subject who signs the informed consent but fails to start on-treatment for any reason will be considered a screen failure. The reason for not starting on-treatment will be entered on the screening failure page or screening disposition page. The demographic inf... | [] |
NCT04870606 | 7.1.1.3 | Subject Demographics and Other Baseline Characteristics | 7.1.1.3 Subject Demographics and Other Baseline Characteristics The data that will be collected at screening includes: - Demography (date of birth and initials (where permitted), sex, race, ethnicity), BMI. - Diagnosis (date and method of confirmation the positive SARS-CoV-2 test result). - Days from onset of COVID-19 ... | [] |
NCT04870606 | 7.1.2 | Treatment Period | 7.1.2 Treatment Period All subjects who are randomized to the study are considered as entering the treatment period. The subjects will be treated 14 consecutive days or less due to AE, lost to follow-up or consent withdrawal. During the treatment period, subjects will self-administrated GT0918 or matched placebo orally... | [] |
NCT04870606 | 7.1.3 | End of Treatment | 7.1.3 End of Treatment | [] |
NCT04870606 | 7.1.3.1 | Study treatment discontinuation | 7.1.3.1 Study treatment discontinuation Subjects may voluntarily discontinue from study treatment for any reason at any time. If a subject decides to discontinue from study treatment, the investigator must make every effort (e.g. telephone, e-mail, letter) to determine the primary reason for this decision and record th... | [] |
NCT04870606 | 7.1.4 | Withdrawal of Consent | 7.1.4 Withdrawal of Consent Early withdrawal is expected to be uncommon. Subjects may voluntarily withdraw consent to participate in the study for any reason at any time. Withdrawal of consent occurs only when a subject: - Does not want to participate in the study anymore, and - Does not allow further collection of per... | [] |
NCT04870606 | 7.1.5 | Follow-Up for Safety Evaluations | 7.1.5 Follow-Up for Safety Evaluations After the end of 14 days treatment period, subjects will enter a 14-day post-treatment (Day 15- Day 28 or 14 days after last dose) and another 14-day safety follow-up periods (Day 29-Day 42 or 14 days after post-treatment) during which information on the subject will be collected ... | [] |
NCT04870606 | 7.1.6 | Lost to Follow-Up | 7.1.6 Lost to Follow-Up For subjects whose status is unclear because they fail to appear for study visits without stating an intention to withdraw consent, the investigator should show "due diligence" by contacting the subject, family or family physician as agreed in the informed consent and by documenting in the sourc... | [] |
NCT04870606 | 7.1.7 | End of Safety Follow-Up | 7.1.7 End of Safety Follow-Up The end of post-treatment phase disposition eCRF page will be completed once a subject has discontinued study treatment, completed safety follow-up. End of post-treatment follow-up may occur one of the following reasons: - AE - Lost to follow-up - Physician's decision - Progressive disease... | [] |
NCT04870606 | 7.2 | Assessment | 7.2 Assessment Planned time points for all safety assessments are provided in the [SoA.](#page-23-1) | [] |
NCT04870606 | 7.2.1 | Efficacy Assessments | 7.2.1 Efficacy Assessments Non-Hospitalization events [\(7.2.1.1\)](#page-59-3), NIAID ordinal scale [\(7.2.1.2\)](#page-60-1) , symptom improvement and resolution(7.2.1.3) will be used to characterize the effect of GT0918 compared to placebo on clinical status from baseline to Days 14 and 28. | [] |
NCT04870606 | 7.2.1.1 | Composite Events for non-Hospitalization | 7.2.1.1 Composite Events for non-Hospitalization The following events by Day 28 will be collected and recorded in the eCRF: - Hospitalization (defined as ≥24 hours) - Supplemental oxygen for ≥24 hours - Death The date of hospitalization events as above will be recorded in the eCRF. Additionally, the date for following ... | [] |
NCT04870606 | 7.2.1.2 | NIAID Ordinal Scale | 7.2.1.2 NIAID Ordinal Scale The National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale will be assessed by the site daily beginning on Day 1 through Day 28 using AE and Questionnaire data. NIAID Ordinal Scale outcomes will be analyzed on Day 7, Day 14 and Day 28.
NIAID Score Description The NIAID ... | [
"NIAID Score Description"
] |
NCT04870606 | 7.2.1.3 | Symptom improvement and resolution | 7.2.1.3 Symptom improvement and resolution Subjects will rate their overall clinical status and severity of symptoms associated with COVID-19 by a daily questionnaire. This questionnaire is for outpatients only. Subjects will complete 3 questions about their overall clinical status daily, including - Severity of sympto... | [] |
NCT04870606 | 7.2.2 | Safety and Tolerability Assessments | 7.2.2 Safety and Tolerability Assessments Safety assessments are specified below with the assessment schedule detailing when each assessment is to be performed. For safety evaluations, baseline is defined as assessments done on Day 1 prior to the first dose of study treatment. The investigator will report any vital sig... | [] |
NCT04870606 | 7.2.2.1 | Physical Examinations | 7.2.2.1 Physical Examinations A complete physical examination will be performed at the screening visit. This examination excludes pelvic, rectal, and breast examinations unless clinically indicated. A symptom directed physical examination will be performed at other visits, as specified in the [SoA](#page-23-1) and as c... | [] |
NCT04870606 | 7.2.2.2 | Vital Signs | 7.2.2.2 Vital Signs Vital signs will be measured as specified in the SoA and as clinically indicated. Vital sign measurements to be measured in the sitting position after 5 mins rest if applicable. Vital signs include: - o Height and weight are only needed at screening - o Body temperature - o Systolic BP, diastolic BP... | [] |
NCT04870606 | 7.2.2.3 | Clinical Laboratory Tests | 7.2.2.3 Clinical Laboratory Tests Local clinical laboratory parameters will be used for the analysis of scheduled hematology, chemistry and other blood specimens collected as part of safety monitoring (as detailed in SoA) and the results will be collected in the eCRF, except for specific parameters which will be perfor... | [] |
NCT04870606 | 7.2.2.4 | Respiratory Support | 7.2.2.4 Respiratory Support Once enrolled in the study, subjects may be managed with high flow nasal cannula, non-invasive positive pressure ventilation or any other form respiratory support as needed per investigator discretion. | [] |
NCT04870606 | 7.2.2.5 | Pregnancy and assessment of fertility | 7.2.2.5 Pregnancy and assessment of fertility All women of childbearing potential must complete a serum pregnancy test at screening visit, urinary pregnancy test at subsequent visits as per the schedule of assessment. Local laboratories will be used for the analysis of serum and urinary pregnancy tests. Women who are d... | [] |
NCT04870606 | 7.2.3 | Pharmacokinetics | 7.2.3 Pharmacokinetics The exposure-response relationship of GT0918 in the treatment of SARS-CoV-2 has not been established. Population PK analyses can be used to further inform dose selection in other populations and support concentration-response investigations with efficacy and safety outcomes. To accomplish this, s... | [] |
NCT04870606 | 7.2.4 | Biomarkers | 7.2.4 Biomarkers Blood samples will be collected from all subjects for exploratory biomarker research at the time specified in the SoA where local regulations allow. The following will be monitored: - C-reactive protein (CRP) - Testosterone - Ferritin - D-dimer - Procalcitonin - Troponin Samples will be stored and anal... | [] |
NCT04870606 | 7.2.5 | Polymerase Chain Reaction (PCR) | 7.2.5 Polymerase Chain Reaction (PCR) The second endpoint is the change from baseline to Day 3, 7, 14, 28 in SARS-CoV-2 viral load based on nasopharyngeal swab samples for reverse transcription-polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 (if it is not able to get the samples at each time point, reason sho... | [] |
NCT04870606 | 7.2.6 | Patient Reported Outcomes | 7.2.6 Patient Reported Outcomes Subjects will be provided Subject's Diary which will contain the study drug administration information (date/time, with or without meal), and the Symptoms and Overall Clinical Status Subject Questionnaire for subjects to self-evaluate their health status from their own perspective. The q... | [] |
NCT04870606 | 7.2.7 | Virology | 7.2.7 Virology Characterize the effect of GT0918 compared to placebo on SARS-CoV-2 viral load clearance: - Change from baseline to Days 3, 7, 14 and 28 in SARS-CoV-2 viral load. - Proportion of subjects that achieve SARS-CoV-2 clearance (Days 3, 7, 14 and 28) - Time to SARS-CoV-2 clearance. - SARS-CoV-2 viral load area... | [] |
NCT04870606 | 7.2.8 | Development of resistance | 7.2.8 Development of resistance Characterize emergence of virus resistance to GT0918 - Virus load assessment on Day -1/1(baseline prior to first dose), 3, 7, 14, 28. - Exploratory endpoints will include: - o Screening for novel mutants in patients who do not respond to GT0918: - Genotype of SARS-CoV-2 viral isolates. F... | [] |
NCT04870606 | 8 | SAFETY MONITORING AND REPORTING | 8. SAFETY MONITORING AND REPORTING | [] |
NCT04870606 | 8.1 | Adverse Events | 8.1 Adverse Events | [] |
NCT04870606 | 8.1.1 | Definitions and Reporting | 8.1.1 Definitions and Reporting An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after subject's signed informed consent has been obtained. Adverse events that begin or worsen after informed consent should be recorded in the AEs... | [] |
NCT04870606 | 8.1.2 | Events NOT Meeting the AE Definition: | 8.1.2 Events NOT Meeting the AE Definition: - • The following study-specific clinical events related to COVID-19 are exempt from AE reporting unless the investigator deems the event to be related to the administration of study drug: - o Hypoxemia due to COVID-19 requiring supplemental oxygen; - o Hypoxemia due to COVID... | [
"Classification of AEs by Relationship to Study Drug"
] |
NCT04870606 | 8.1.3 | Laboratory Test Abnormalities | 8.1.3 Laboratory Test Abnormalities Laboratory abnormalities that constitute an AE in their own right (are considered clinically significant, induce clinical signs or symptoms, require concomitant therapy, or require changes in study treatment), should be recorded on the AEs CRF. Whenever possible, a diagnosis, rather ... | [] |
NCT04870606 | 8.2 | Adverse Events of Special Interest (AESI) | 8.2 Adverse Events of Special Interest (AESI) The Adverse events of special interest (AESI) search table will be used to map reported AEs to the notable AE groupings. AESI could be updated during the course of study based on accumulating safety data. Therefore the clinical study report includes the AE groupings (such a... | [] |
NCT04870606 | 8.3 | Serious Adverse Events | 8.3 Serious Adverse Events | [] |
NCT04870606 | 8.3.1 | Definitions | 8.3.1 Definitions If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease). An SAE is defined as one of the following: - Is fatal - Is life-threatening - Results i... | [] |
NCT04870606 | 8.3.2 | SAE Reporting | 8.3.2 SAE Reporting To ensure patient safety, every SAE, regardless of suspected causality, occurring after the subject has provided informed consent and until at least 28 days after the patient has stopped study treatment must be reported to Kintor/delegated CRO within 24 hours of learning of its occurrence. Any SAEs ... | [] |
NCT04870606 | 8.4 | Suspected Unexpected Serious Adverse Reactions (SUSARs) | 8.4 Suspected Unexpected Serious Adverse Reactions (SUSARs) Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected and reported to the competent regulatory authorities and relevant IECs in accordance with Directive 2001/20/EC or as per national regulatory requirements in participating countries. If t... | [] |
NCT04870606 | 8.5 | Emergency Unblinding of Treatment Assignment | 8.5 Emergency Unblinding of Treatment Assignment Emergency unblinding should only be undertaken for safety reasons when it is essential for effective treatment of the subject. Most often, study treatment discontinuation and knowledge of the possible treatment assignments are sufficient to treat a study patient who pres... | [] |
NCT04870606 | 8.6 | Pregnancies | 8.6 Pregnancies To ensure subject safety, each pregnancy occurring after the start of study treatment and until 90 days after the last dose of study drugs must be reported to Kintor/delegated CRO immediately (within 24 hours) of learning of its occurrence. The subjects who become pregnant during the study must be withd... | [] |
NCT04870606 | 8.7 | Warnings and Precaution | 8.7 Warnings and Precaution No evidence available at the time of the approval of this study protocol indicated that special warnings or precautions were appropriate, other than those noted in the provided Investigator Brochure (IB). Additional safety information collected between IB updates will be communicated in the ... | [] |
NCT04870606 | 8.8 | Independent Data Monitoring Committee (IDMC) | 8.8 Independent Data Monitoring Committee (IDMC) An IDMC will be constituted and will be responsible for monitoring and reviewing the clinical study data for safety and efficacy during the study prior to the final data analysis. To minimize any bias introduced into the analysis of the study results, analysis plans will... | [] |
NCT04870606 | 8.9 | Steering Committee | 8.9 Steering Committee The SC will be established comprising investigators participating in the study, and Kintor representatives from the clinical study team. The SC will be an advisory board for the study according to the protocol through recommending modifications as circumstances require. The SC will be consulted f... | [] |
NCT04870606 | 9 | DATA COLLECTION AND MANAGEMENT | 9. DATA COLLECTION AND MANAGEMENT | [] |
NCT04870606 | 9.1 | Data Confidentiality | 9.1 Data Confidentiality Prior to any testing under this protocol, including screening tests and assessments, subjects must also provide all authorizations required by local law (e.g., PHI authorization in North America). The subject will not be identified by name in the CRF or in any study reports and these reports wi... | [] |
NCT04870606 | 9.2 | Site Monitoring | 9.2 Site Monitoring At regular intervals during the study, the site will be contacted through monitoring visits or remote monitoring, letters, and telephone calls by a representative to review study progress, Investigator and subject compliance with study protocol requirements, and any emergent problems. During monitor... | [] |
NCT04870606 | 9.3 | Data Collections | 9.3 Data Collections All data obtained for analysis in the clinical study described in this protocol will be reported in the CRF. Data reported in the CRFs should be consistent with and substantiated by the subject's medical record and original source documents. Any discrepancies must be explained. Unless explicitly al... | [] |
NCT04870606 | 9.4 | Database Management | 9.4 Database Management A designated CRO will be responsible for data management. Data Management will develop a Data Management Plan (DMP) document and provide it to Suzhou Kintor Pharmaceuticals, Inc. for approval. The DMP document will define all activities in the data collection and cleaning process. The detailed D... | [] |
NCT04870606 | 9.5 | Quality Control | 9.5 Quality Control The Sponsor or its designee will perform the quality assurance and quality control activities of this study; however, responsibility for the accuracy, completeness, and reliability of the study data presented to the Sponsor lies with the Investigator generating the data. The Sponsor will arrange aud... | [] |
NCT04870606 | 10 | STATISTICAL METHODS AND DATA ANALYSIS | 10. STATISTICAL METHODS AND DATA ANALYSIS | [] |
NCT04870606 | 10.1 | General Considerations | 10.1 General Considerations It is planned that the data from all centers participating in the study will be combined, so that an adequate number of patients are available for analysis. Kintor and/or a designated CRO will perform all analyses. And data analyses performed independently by any investigator should be submi... | [] |
NCT04870606 | 10.2 | Analysis Sets | 10.2 Analysis Sets | [] |
NCT04870606 | 10.2.1 | Intent-to-Treat Analysis Set (ITT) | 10.2.1 Intent-to-Treat Analysis Set (ITT) The intent-to-treat analysis set includes all randomized subjects. | [] |
NCT04870606 | 10.2.2 | Modified Intent-to-Treat Analysis Set (mITT) | 10.2.2 Modified Intent-to-Treat Analysis Set (mITT) The mITT analysis set includes all randomized subjects who have received at least one dose of the study treatment. The primary efficacy analysis will be conducted on the mITT Analysis Set. | [] |
NCT04870606 | 10.2.3 | Safety Analysis Set (SS) | 10.2.3 Safety Analysis Set (SS) The safety analysis set includes all subjects with at least one dose of study medication. The disposition, study summary, and safety analysis will be conducted on Safety Analysis Set. | [] |
NCT04870606 | 10.2.4 | Per-Protocol Analysis Set (PPS) | 10.2.4 Per-Protocol Analysis Set (PPS) The per-protocol analysis set includes all ITT subjects without major protocol violations. The per-protocol analysis set will be defined under classification specification prior to unblinding of the study treatment code. | [] |
NCT04870606 | 10.2.5 | Pharmacokinetic Analyses | 10.2.5 Pharmacokinetic Analyses Pharmacokinetic analyses will be conducted on data from at least 100 subjects who receive intervention and have evaluable PK. | [] |
NCT04870606 | 10.3 | Subject Demographics/Other Baseline Characteristics | 10.3 Subject Demographics/Other Baseline Characteristics Demographics and other baseline data including age, age group, race, ethnicity, BMI, baseline disease, underlying medical conditions 0, 1-2, ≥3 (as defined in [Section 4.1.1.](#page-42-1)), and other disease characteristics will be summarized descriptively by tre... | [] |
NCT04870606 | 10.4 | Treatments (Study Treatment, Concomitant Therapies, Compliance) | 10.4 Treatments (Study Treatment, Concomitant Therapies, Compliance) The safety set will be used for the analyses below. The actual dose and duration of GT0918, as well as dose intensity (computed as the ratio of actual dose received to actual duration) and the relative dose intensity (computed as the ratio of the dose... | [] |
NCT04870606 | 10.5 | Efficacy Analysis | 10.5 Efficacy Analysis | [] |
NCT04870606 | 10.5.1 | Primary Efficacy Objective | 10.5.1 Primary Efficacy Objective The primary objective is to evaluate the efficacy of GT0918 in subjects with mild to moderate COVID-19 illness. | [] |
NCT04870606 | 10.5.1.1 | Primary Efficacy Variable | 10.5.1.1 Primary Efficacy Variable The primary efficacy endpoint is the proportion of subjects who do not experience any of the following events due to all causes by Day 28: - Hospitalization for ≥ 24 hours - Supplemental oxygen for ≥24 hours in response to SpO2 ≤93% - Death | [] |
NCT04870606 | 10.5.1.2 | Statistical Hypothesis, Model, and Method of Analysis | 10.5.1.2 Statistical Hypothesis, Model, and Method of Analysis Primary Null Hypothesis H0: proportion of subjects who do not experience all-cause hospitalization (defined as ≥24 hours) and do not require supplemental oxygen for ≥24h in response to SpO2≤93% and are alive by Day 28 in the GT0918 arm (p1) is equal to the ... | [] |
NCT04870606 | 10.5.1.3 | Handling of Dropouts, Missing Values/Censoring/Discontinuations | 10.5.1.3 Handling of Dropouts, Missing Values/Censoring/Discontinuations No dropouts will be replaced. Every effort will be made to avoid missing data. All subjects will be followed fully in the trial whenever possible. All patients who maintain consent to be followed for additional outcome information should remain in... | [] |
NCT04870606 | 10.5.1.4 | Subgroup Analyses | 10.5.1.4 Subgroup Analyses This study is not powered for subgroup analyses; therefore, all subgroup analyses will be treated as exploratory. Subgroup analyses will be conducted for the primary endpoint and displayed graphically in forest plots. Subgroups may include: - o time from symptom onset to study randomization -... | [] |
NCT04870606 | 10.5.1.5 | Sensitivity Analyses | 10.5.1.5 Sensitivity Analyses Sensitivity analysis of the primary endpoint analysis will be conducted. Details will be specified in the SAP. | [] |
NCT04870606 | 10.5.2 | Secondary Objectives Variables | 10.5.2 Secondary Objectives Variables | [] |
NCT04870606 | 10.5.2.1 | Hospitalization percentage | 10.5.2.1 Hospitalization percentage The percentage of subjects with all-cause and COVID-19 related hospitalization (defined as ≥24 hours) or requirement for supplemental oxygen for ≥24h in response to SpO2≤93% or death by Day 28 will be analyzed. The proportion of subjects that experience hospitalization, supplemental ... | [] |
NCT04870606 | 10.5.2.2 | COVID-19 Ordinal Outcomes Scale | 10.5.2.2 COVID-19 Ordinal Outcomes Scale The percentage of subjects at each clinical status using NIAID ordinal scale at Days 7, 14, and 28 will be analyzed. 1. Death - 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) - 3. Hospitalized, on non-invasive ventilation or hig... | [] |
NCT04870606 | 10.5.2.3 | Proportion of Symptom resolution | 10.5.2.3 Proportion of Symptom resolution For each symptom resolution is defined as absent for at least 48 hours. The proportion of subjects with symptom resolution will be analyzed by symptom. All symptom resolution is defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent. The propor... | [] |
NCT04870606 | 10.5.2.4 | Time to symptom resolution | 10.5.2.4 Time to symptom resolution Time to all symptom resolution is defined (in days) as: First study day when symptom resolution status is changed to "Yes" – first dosing Date + 1. If a patient has not experienced symptom resolution by completion or early discontinuation of study/study treatment, the patient will be... | [] |
NCT04870606 | 10.5.2.5 | Symptom Improvement | 10.5.2.5 Symptom Improvement 10.5.2.5.1 Proportion of subjects demonstrating symptom improvement via the symptom questionnaire on Days 3, 7, 14 and 28. Symptom improvement is defined as a change in severity of total ratings from a higher score to a lower scorewhich is defined as following: • symptoms scored as moderate... | [] |
NCT04870606 | 10.5.2.6 | Time to Symptom Improvement | 10.5.2.6 Time to Symptom Improvement Time to symptom improvement is defined (in days) as: (Date when symptom improvement status is changed to "Yes" – first dosing Date + 1). If a subject has not experienced symptom improvement by completion or early discontinuation of study/study treatment, the patient will be censored... | [] |
NCT04870606 | 10.5.2.7 | Virus Clearance | 10.5.2.7 Virus Clearance Proportion of subjects that achieve SARS-CoV-2 clearance at Days 3, 7, 14 and 28. The proportion of subjects that achieve SARS-CoV-2 clearance at Days 3, 7, 14, and 28 will be summarized by treatment in frequency tables and listed. | [] |
NCT04870606 | 10.5.2.8 | Time to SARS-CoV-2 clearance | 10.5.2.8 Time to SARS-CoV-2 clearance Time to SARS-CoV-2 clearance will be evaluated by day 28 and will be summarized by treatment and listed. Time to SARS-CoV-2 clearance will be presented graphically. | [] |
NCT04870606 | 10.5.2.9 | Viral load reduction | 10.5.2.9 Viral load reduction SARS-CoV-2 viral load, including changes from baseline, will be summarized and plotted by treatment and listed. Baseline is defined as the Day 1 pre-dose assessment. Changes from baseline to Day 3, 7, 14 and 28 in SARS-CoV-2 viral load data in the log base 10 scale will be analyzed using a... | [] |
NCT04870606 | 10.6 | Exploratory Objectives | 10.6 Exploratory Objectives | [] |
NCT04870606 | 10.6.1 | Pharmacokinetics of GT0918 | 10.6.1 Pharmacokinetics of GT0918 PK concentrations of GT0918 (and any relevant metabolites such as GT0955) will be summarized by time point using descriptive statistics by treatment only for GT0918 arm. All PK concentration data will be listed as appropriate
Data handling principles Plasma samples may be assayed for ... | [
"Data handling principles"
] |
NCT04870606 | 10.6.2 | Viral resistance to GT0918 | 10.6.2 Viral resistance to GT0918 If appropriate, the evaluation of viral resistance will be conducted as described in a separate bioanalytical analysis plan. Comparison from baseline to the last evaluable time point up to Day 28 on the emergence of viral resistance to GT0918. | [] |
NCT04870606 | 10.7 | Safety Analysis | 10.7 Safety Analysis | [] |
NCT04870606 | 10.7.1 | Analysis set and grouping for the analyses | 10.7.1 Analysis set and grouping for the analyses For all safety analyses, the safety set will be used. All listings and tables will be presented by treatment group. The overall observation period will be divided into 3 mutually exclusive segments: - 1. pre-treatment period: from day of patient's informed consent to th... | [] |
NCT04870606 | 10.7.2 | Adverse events | 10.7.2. Adverse events Summary tables for AEs have to include only AEs that started or worsened during the on-treatment period, the treatment-emergent AEs. However, all safety data (including those from the pre and post-treatment periods) will be listed and those collected during the pre-treatment and posttreatment per... | [] |
NCT04870606 | 10.7.3 | Laboratory abnormalities | 10.7.3 Laboratory abnormalities For laboratory tests covered by DAIDS Version 2.1, a Grade 0 will be assigned for all non-missing values not graded as 1 or higher. For laboratory tests where grades are not defined by DAIDS, results will be graded by the low/normal/high classifications based on laboratory normal ranges.... | [] |
NCT04870606 | 10.7.4 | Other safety data | 10.7.4 Other safety data | [] |
NCT04870606 | 10.7.4.1 | Vital signs | 10.7.4.1 Vital signs - Shift table from baseline to worst on-treatment result. - • Table with descriptive statistics at baseline, one or several post-baseline time points and change from baseline to this/these post-baseline time points. | [] |
NCT04870606 | 10.7.4.2 | Tolerability | 10.7.4.2 Tolerability Tolerability will be studied in terms of dose discontinuation due to AE. Reasons for dose discontinuation will be listed and summarized by treatment. | [] |
NCT04870606 | 10.8 | Interim Analysis | 10.8 Interim Analysis An interim analysis will be conducted when 334 subjects completed Day 28 after first dose. The objective of the interim analysis to assess safety, futility, efficacy, sample size adjustment as well as potential enrichment of the population to enroll a population at higher risk for an infection req... | [] |
NCT04870606 | 10.9 | Sample Size Calculation | 10.9 Sample Size Calculation The primary endpoint event rate for the treatment arm is assumed at 97 % and for the placebo arm is assumed at 91%. The sample size was calculated using EAST v6.5 for a group sequential test for 2 proportions. With a total of 668 subjects the study will have 90% power at a one-sided 0.025 s... | [] |
NCT04870606 | 11 | ETHICAL CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES | 11. ETHICAL CONSIDERATIONS AND ADMINISTRATIVE PROCEDURES | [] |
NCT04870606 | 11.1 | Regulatory and Ethical Compliance | 11.1 Regulatory and Ethical Compliance This study will be conducted in accordance with the protocol and with the following: - • Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International E... | [] |
NCT04870606 | 11.2 | Responsibilities of the Investigator and IRB/IEC/REB | 11.2 Responsibilities of the Investigator and IRB/IEC/REB All subject data relating to the study will be recorded on printed or electronic CRF unless transmitted to the Sponsor or designee electronically (e.g., laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by... | [] |
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