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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NCT04625101 | 13.10 | Efficacy Data | 13.10. Efficacy Data Primary efficacy endpoint: • Ratio of SWI at the end of to baseline during the first hour (60 minutes) of NREM sleep based on centralized video-EEG reading, where baseline is defined as the last value measured prior to intake of study treatment on Day 1. The primary endpoint was selected based on t... | [] |
NCT04625101 | 13.11 | Safety Data | 13.11. Safety Data Safety analyses will be performed using the Safety set. AEs will be summarized (frequency counts and percentages) by system organ class and/or preferred term, and maximum intensity. Descriptive summary statistics of the observed values and changes from baseline to each scheduled visit in clinical lab... | [] |
NCT04625101 | 13.12 | Sentinel Cohort Analysis | 13.12. Sentinel Cohort Analysis  The unblinded analysis of safety and tolerability data for the sentinel cohort will be conducted by the IDMC. The analysis of the PK data through in the sentinel cohort will be conducted by an independent, unblinded vendor; this vendor will provide reports to the ... | [] |
NCT04625101 | 14 | REGULATORY AND ETHICAL ISSUES | 14. REGULATORY AND ETHICAL ISSUES | [] |
NCT04625101 | 14.1 | General Legal References | 14.1. General Legal References The study will be carried out according to provisions of the US CFR, the US Food and Drug Administration (FDA), the laws and regulations of the country in which the study is conducted, and the ICH Guidelines for GCP. All clinical work conducted under this protocol is subject to GCP regula... | [] |
NCT04625101 | 14.2 | Institutional Review Board/Independent Ethics Committee | 14.2. Institutional Review Board/Independent Ethics Committee The final approved protocol and the ICF will be reviewed by the IRB/IEC at the study center. The committee's decision concerning conduct of the study will be sent in writing to the investigator and a copy will be forwarded to the Sponsor. The investigator mu... | [] |
NCT04625101 | 14.3 | Protocol Adherence – Amendments | 14.3. Protocol Adherence – Amendments The protocol must be read thoroughly, and the instructions must be followed exactly. Any changes in the protocol will require a formal amendment. Such amendments will be agreed upon and approved in writing by the investigator and the Sponsor. The IRB/IEC and local health authoritie... | [] |
NCT04625101 | 14.4 | Required Documents | 14.4. Required Documents The investigator must provide the Sponsor or its designee with the following documents before the enrollment of any subject (originals should be kept by the investigator in the investigator's study regulatory document binder): - Signed copy of the protocol signature page. - Investigator's Broch... | [] |
NCT04625101 | 14.5 | Informed Consent | 14.5. Informed Consent Parent(s) or legal guardian(s) will provide informed consent with pediatric assent (if developmentally capable of providing assent) before the performance of any study-related procedures. Consent/assent may be done remotely, if allowed per the site's institutional policy and remote consenting pro... | [] |
NCT04625101 | 14.6 | Study Monitoring | 14.6. Study Monitoring Throughout the course of the study, the study monitor will make frequent contacts with the investigator. This will include telephone calls and on-site visits. During the on-site visits, the eCRFs will be reviewed for completeness and adherence to the protocol. As part of the data audit, source do... | [] |
NCT04625101 | 14.7 | Quality Assurance | 14.7. Quality Assurance The study will be conducted in accordance with the Sponsor's standard operating procedures designed to ensure that all procedures are in compliance with GCP and FDA Guidelines, and according to all local and federal regulations. Quality assurance audits may be performed at the discretion of the ... | [] |
NCT04625101 | 14.8 | Record Retention | 14.8. Record Retention Study records should be retained in compliance with all local and federal regulations of the clinical site. The Sponsor may request these records to be retained for a longer period if required by applicable regulatory requirements or Sponsor contractual obligations. If the investigator is unable ... | [] |
NCT04625101 | 14.9 | Confidentiality | 14.9. Confidentiality The Sponsor or its designee, and the study center affirm and uphold the principle of the subject's right to protection against invasion of privacy. Throughout this study, all data will be identified only by an identification number. All information concerning this study and which was not previousl... | [] |
NCT04625101 | 14.10 | Publication Policy | 14.10. Publication Policy The Sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. Authorship will be determine... | [] |
NCT04625101 | 15 | STUDY COMMENCEMENT AND DISCONTINUATION | 15. STUDY COMMENCEMENT AND DISCONTINUATION The Sponsor reserves the right to terminate the study at any time globally or locally. Investigators can terminate the participation of their site in the study at any time. If a study is suspended or prematurely terminated, the sponsor will promptly inform the investigators, t... | [] |
NCT04625101 | 16 | REFERENCES | 16. REFERENCES Aeby A, Poznanski N, Verheulpen D, Wetzburger C, Van Bogaert P. Levetiracetam efficacy in epileptic syndromes with continuous spikes and waves during slow sleep: experience in 12 cases. Epilepsia. 2005 Dec;46(12):1937-42. Bölsterli BK, Schmitt B, Bast T, Critelli H, Heinzle J, Jenni OG, et al. Impaired s... | [] |
NCT04627285 | A | MULTICENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM USE OF ORAL LACOSAMIDE IN STUDY PARTICIPANTS WHO COMPLETED EP0034 OR SP848 AND RECEIVED LACOSAMIDE TREATMENT This document cannot be used to support any marketing authorization | A MULTICENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM USE OF ORAL LACOSAMIDE IN STUDY PARTICIPANTS WHO COMPLETED EP0034 OR SP848 AND RECEIVED LACOSAMIDE TREATMENT This document cannot be used to support any marketing authorization
PROTOCOL EP0151 AMENDMENT 1 PHASE 3B application and any extensions or vari... | [
"PROTOCOL EP0151 AMENDMENT 1 PHASE 3B application and any extensions or variations thereof.",
"SHORT TITLE:",
"Confidential",
"PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE",
"Amendment 1 (12 Oct 2023)",
"Overall Rationale for the Amendment",
"SERIOUS ADVERSE EVENT REPORTING",
"1 PROTOCOL SUMMARY",
"1... |
NCT04642950 | 1 | Synopsis | 1 Synopsis | Study title | A phase II/III study of sargramostim in patients with coronavirus disease-2019(COVID | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04642950 | 2 | Observation and Examination Schedule | 2 Observation and Examination Schedule | | Screening | Date ofallocation | Observation period 5) | | | | | | | | | | | Discontinuation/Exit Test 6) | | |---------------------------------------------------------------|-----------|-----------------------|-----------------------|-------|-------|-------|--------------|----... | [] |
NCT04642950 | 3 | Study Administrative Structure | 3 Study Administrative Structure Refer to Attachment 1 for the study administrative structure. | [] |
NCT04642950 | 4 | Background Information | 4 Background Information Refer to the latest Investigator's Brochure2 for more background information on sargramostim. | [] |
NCT04642950 | 4.1 | Introduction | 4.1 Introduction As of September 7, 2020, approximately 27 million people have been affected with COVID-19 worldwide and more than 70,000 people in Japan, and the number of deaths is also continuously increasing to reach 900,000 worldwide3,4 . While many affected individuals end with subclinical infection, those who be... | [] |
NCT04642950 | 4.2 | Nonclinical studies | 4.2 Nonclinical studies The nonclinical toxicity studies required to initiate clinical studies of sargramostim have been evaluated in repeated-dose toxicity studies in monkeys including a 14 days intravenous administration study, a 6 weeks subcutaneous administration study, and a 26 weeks inhalation administration (int... | [] |
NCT04642950 | 4.3 | Clinical studies | 4.3 Clinical studies Inhalation administration of sargramostim has been experienced in humans in the Phase I studies in healthy adults and patients with autoimmune pulmonary alveolar proteinosis8 , a Phase II study9 in patients with autoimmune pulmonary alveolar proteinosis (6 cycles of 125 μg inhaled twice daily for 8... | [] |
NCT04642950 | 4.4 | Known or unknown adverse drug reactions | 4.4 Known or unknown adverse drug reactions The most recent Investigator's Brochure2 shall be referred to for potential risks of sargramostim administration. When sargramostim is administered by inhalation in COVID-19 patients, no other adverse events (AEs) will be anticipated than those related to COVID-19. COVID-19 i... | [] |
NCT04642950 | 5 | Objective, Endpoints, and Parameters | 5 Objective, Endpoints, and Parameters | [] |
NCT04642950 | 5.1 | Objective | 5.1 Objective To evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to standard treatment in COVID-19 patients. | [] |
NCT04642950 | 5.2 | Endpoints | 5.2 Endpoints | [] |
NCT04642950 | 5.2.1 | Efficacy endpoints | 5.2.1 Efficacy endpoints
Primary efficacy endpoint Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
[Rationale] A 7-point ordinal scale is one of the commonly used scales for assessment of drugs used in the clinical studies of COVID-19 and was set as an inde... | [
"Primary efficacy endpoint",
"[Rationale]",
"Secondary endpoints",
"[Rationale]"
] |
NCT04642950 | 5.2.1.1 | Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale | 5.2.1.1 Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale The clinical condition of a subject will be comprehensively measured at the timing specified in "2 Observation and Examination Schedule" and will be evaluated according to "13.3 7-point ordinal scale" by the investigators. Assessme... | [] |
NCT04642950 | 5.2.1.2 | Changes in alveolar -arterial oxygen gradient (A-aDO2) | 5.2.1.2 Changes in alveolar -arterial oxygen gradient (A-aDO2) A-aDO2 will be measured and calculated according to "13.10 Arterial blood-gas analysis (PaO2, PaCO2, A-aDO2, others) " at the timing specified in "2 Observation and Examination Schedule." Measurement values obtained prior to study drug administration on Day... | [] |
NCT04642950 | 5.2.1.3 | Number of days until discharge | 5.2.1.3 Number of days until discharge The category of the disease condition on Day 0 of a subject is supposed to fall into one of Category 3 to 5 on a 7-point ordinal scale (see Table 13.3-1). The number of days required to have been shifted from the category on Day 0 to Category 7 will be evaluated. | [] |
NCT04642950 | 5.2.1.4 | Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale | 5.2.1.4 Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale The category of the disease condition on Day 0 of a subject is supposed to fall into one of Category 3 to 5 on a 7-point ordinal scale (see Table 13.3-1). The proportion of subjects whose category has shifted from th... | [] |
NCT04642950 | 5.2.1.5 | Changes in pulmonary inflammatory findings | 5.2.1.5 Changes in pulmonary inflammatory findings Inflammatory findings in the lungs will be examined according to "13.11 Chest HRCT or plain chest CT or chest X-ray" at the timing specified in "2 Observation and Examination Schedule", and the results will be judged by the investigators. Quantitative changes will be a... | [] |
NCT04642950 | 5.2.1.6 | Changes in arterial blood gas parameters (PaO2, PaCO2) | 5.2.1.6 Changes in arterial blood gas parameters (PaO2, PaCO2) PaO2 and PaCO2 will be measured according to "13.10 Arterial blood gas analysis(PaO2, PaCO2, AaDO2, others)" at the timing specified in "2 Observation and Examination Schedule". Measurement values prior to study drug administration on Day 1 will be used as ... | [] |
NCT04642950 | 5.2.1.7 | Changes in inflammatory markers and cytokines | 5.2.1.7 Changes in inflammatory markers and cytokines Inflammatory markers and cytokines will be measured according to "13.8 Inflammatory marker" and "13.9 Cytokines" at the timing specified in "2 Observation and Examination Schedule". Measurement values prior to study drug administration on Day 1 is used as baseline v... | [] |
NCT04642950 | 5.2.1.8 | Distribution and proportion of each category on a 7-point ordinal scale | 5.2.1.8 Distribution and proportion of each category on a 7-point ordinal scale Distribution of category (Category 1-7) on a 7-point ordinal scale (see Table 13.3-1) and the proportion of each category will be evaluated. Details of the categories will be defined in the statistical analysis plan separately. | [] |
NCT04642950 | 5.2.1.9 | Distribution and proportion of each category of oxygen requirement | 5.2.1.9 Distribution and proportion of each category of oxygen requirement Oxygen requirement will be classified into 5 categories (see Table 13.12-1) and the distribution and proportion of each category will be evaluated. Details of the categories will be defined in the statistical analysis plan separately. | [] |
NCT04642950 | 5.2.2 | Safety endpoints | 5.2.2 Safety endpoints Incidence of adverse events (AEs) and serious adverse events (SAEs)
[Rationale] An event reported as an AE is not only the subjective symptoms reported by the subject, but also reflects the medical judgment of the investigators based on the results of the safety assessment. The incidence of AEs ... | [
"[Rationale]"
] |
NCT04642950 | 5.2.2.1 | Incidence of AEs and SAEs | 5.2.2.1 Incidence of AEs and SAEs Information on AEs occurring from the start of study drug administration until Day 14 will be collected in this study. For SAEs related to the study drug, those occurring until Day 28 will be collected. The number of subjects with AEs and the incidence of AEs will be calculated by seri... | [] |
NCT04642950 | 5.3 | Parameters | 5.3 Parameters | [] |
NCT04642950 | 5.3.1 | Efficacy parameters | 5.3.1 Efficacy parameters 7-point Ordinal scale, arterial blood gas analysis (PaO2, PaCO2, A-aDO2, others), HRCT or chest simple CT or chest X-ray, inflammatory markers, cytokines, oxygen requirement. | [] |
NCT04642950 | 5.3.2 | Safety parameters | 5.3.2 Safety parameters Physical examination, vital signs, 12-lead ECG, laboratory tests (blood chemistry, hematology, urinalysis, and pregnancy test), AEs. | [] |
NCT04642950 | 6 | Study Design | 6 Study Design | [] |
NCT04642950 | 6.1 | Overview of study design | 6.1 Overview of study design This is a randomized, placebo-controlled, double-blind, group-comparison, multicenter study. The efficacy and safety will be evaluated when sargramostim or physiological saline is administered by inhalation for 5 days, in principle (up to 10 days) as Add-on treatment to standard treatment i... | [] |
NCT04642950 | 6.2 | Rationale for study design | 6.2 Rationale for study design The objective of the study is to verify the efficacy and safety of sargramostim, thus, a randomized, placebo-controlled, double-blind, group comparison study design has been chosen to avoid any biases including biases in assessment of the investigators. There are currently no established ... | [] |
NCT04642950 | 6.3 | Rationale for dosage and administration | 6.3 Rationale for dosage and administration Dosage and administration of the study drug in this study is based on the fact that the efficacy and safety in Japanese patients with autoimmune pulmonary alveolar proteinosis have been confirmed on the same dosage and administration"®, and that the efficacy of sargramostim w... | [] |
NCT04642950 | 7 | Subjects | 7 Subjects Patients with moderate-II coronavirus disease-2019 (COVID-19) who were clinically diagnosed pneumonia.
[Rationale] Considering the mechanism of action of sargramostim, patients with clinically diagnosed pneumonia whose respiratory function is suggestively decreased are to be included in the study. In additi... | [
"[Rationale]"
] |
NCT04642950 | 7.1 | Inclusion criteria | 7.1 Inclusion criteria Japanese male or female subjects who have been confirmed to meet all the following criteria. - (1) Hospitalized patients under treatment who were severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] positive by polymerase chain reaction (PCR) test. - (2) Patients with clinically diagnosed... | [
"[Rationale]"
] |
NCT04642950 | 7.2 | Exclusion criteria | 7.2 Exclusion criteria Subjects who meet any of the following criteria will be excluded. Unless otherwise stated, the following criteria refer to those at the time of screening. - (1) Patients who have allergic reactions or hypersensitivity to the active ingredient of the test drug (sargramostim) or its additives (mann... | [
"[Rationale]"
] |
NCT04642950 | 8 | Subject Information, Informed Consent, and Subject Authorization | 8 Subject Information, Informed Consent, and Subject Authorization | [] |
NCT04642950 | 8.1 | Informed consent form | 8.1 Informed consent form Prior to the implementation of the study, the principal investigator will collaborate with the sponsor, prepare an informed consent form, submit it to the head of the medical institution for approval by the Institutional Review Board (IRB), and submit the approved informed consent form to the ... | [] |
NCT04642950 | 8.2 | Timing and procedures for obtaining informed consent | 8.2 Timing and procedures for obtaining informed consent | [] |
NCT04642950 | 8.2.1 | Explanation of the clinical study and obtaining informed consent | 8.2.1 Explanation of the clinical study and obtaining informed consent After the clinical study agreement between the medical institution and the sponsor has been signed, the investigators shall explain the details of the clinical study, etc., using the explanation materials for informed consent form to the candidate p... | [] |
NCT04642950 | 8.2.2 | Delivery of informed consent form | 8.2.2 Delivery of informed consent form The investigators shall provide the candidate patient or the legally acceptable representative with a copy of the informed consent form signed and sealed or signed by the investigators and the candidate patient as well as the explanation materials. The investigators shall provide... | [] |
NCT04642950 | 8.3 | Obtaining new information and revision of informed consent form | 8.3 Obtaining new information and revision of informed consent form If new information has been obtained that may affect the willingness of the subject and the legally acceptable representative to continue participating in the clinical study, the investigators shall revise the informed consent form based on the new inf... | [] |
NCT04642950 | 8.4 | Others | 8.4 Others The investigators shall comply with the following items when obtaining informed consent from the candidate patient and the legally acceptable representative. - ① The investigators shall not give unjustified effect such that they force to participate or continue participation in a clinical study to the candid... | [] |
NCT04642950 | 9 | Study Drug | 9 Study Drug | [] |
NCT04642950 | 9.1 | Test drug | 9.1 Test drug Non-proprietary name:sargramostim (Code name: NPC-26) Dosage form/Strength:A lyophilized preparation containing 250 μg of sargramostim in 1 vial Storage conditions:4℃ (2 to 8℃) | [] |
NCT04642950 | 9.2 | Packaging and labeling of test drug | 9.2 Packaging and labeling of test drug The vials will be placed in individual packaging boxes. The label and package will contain the following information. Expiration date will be specified in a separate written procedure. - A statement that the test drug is for clinical study use. - Name and address of the sponsor. ... | [] |
NCT04642950 | 9.3 | Physiological saline for dissolution of the test drug and for the control group | 9.3 Physiological saline for dissolution of the test drug and for the control group In the active treatment group in the study, the test drug will be dissolved in physiological saline and administered by inhalation. In the control group, the physiological saline itself will be administered by inhalation (see "10.3 Admi... | [] |
NCT04642950 | 9.4 | Management of test drug | 9.4 Management of test drug - (1) The sponsor will deliver the test drug and the " Investigational product handling procedures" to the Investigational product manager after a contractual agreement with the medical institution has been signed. - (2) The Investigational product manager will store and manage the test drug... | [] |
NCT04642950 | 10 | Study Procedures | 10 Study Procedures This is a randomized, placebo-controlled, double-blind, group-comparison, multicenter study. Refer to Figure 6.1-1 for the study design. | [] |
NCT04642950 | 10.1 | Enrollment of subject | 10.1 Enrollment of subject The investigators will assign a subject identification code to subjects in the order of giving informed consent, and enter the information of the eligible randomized subjects in the electronic case report form (eCRF). The subject identification code will be composed of a two-digit number assi... | [] |
NCT04642950 | 10.2 | Randomization | 10.2 Randomization Randomization will be performed by the unblinded pharmacist using the web-automated responsiveness system (IWRS) of the eCRF. The unblinded pharmacist shall be specifically in charge of allocation, preparation and arrangement of the study drug and must not perform any other study-related duties other... | [] |
NCT04642950 | 10.3 | Administration of study drug | 10.3 Administration of study drug Administration of study drug will start in the morning of Day 1 (twice daily, in the morning and evening between Day 1 and Day 5). In the active treatment group, 250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline, and 2 mL of which will be administered twice ... | [] |
NCT04642950 | 10.4 | Disclosure of allocation code in an emergency | 10.4 Disclosure of allocation code in an emergency When disclosure of allocation code in an emergency is requested by the investigators through the sponsor in the event of a serious adverse event, the unblinded pharmacist will disclose the allocation code of the subject in accordance with the procedures provided by the... | [] |
NCT04642950 | 10.5 | Unblinding after completion of clinical study | 10.5 Unblinding after completion of clinical study The allocation code for this study will be stored in the EDC system, but only the unblinded pharmacist and the unblinded monitors will be allowed to review the code during the study period. After completion of the clinical study, the data will be locked in the blinded ... | [] |
NCT04642950 | 11 | Concomitant Medication/Therapy | 11 Concomitant Medication/Therapy A standard treatment for each subject against COVID-19 will be chosen and performed appropriately based on medical judgment, with reference to current knowledge and guideline1, 16, 17 . Concomitant use of any unapproved drugs (including off-label use of approved drug and use at unappro... | [] |
NCT04642950 | 12 | Management of Subject | 12 Management of Subject If a subject is discharged from the hospital during the study period, the subject shall be appropriately instructed to receive the observation/examination at the timing specified in the "2 Observation and Examination Schedule" and to avoid pregnancy or breastfeeding until the last observation f... | [] |
NCT04642950 | 13 | Measurement of Parameters | 13 Measurement of Parameters In accordance with "2 Observation and Examination Schedule", observations/examinations and evaluations will be performed, and the date and the results of observations/examinations will be recorded in the source documents such as the medical record. In addition, the prespecified data will be... | [] |
NCT04642950 | 13.1 | Subject characteristics | 13.1 Subject characteristics The date of informed consent, date of birth, sex, height, weight, alcohol consumption, smoking history, presence or absence of allergies (drugs, food, etc.), date of COVID-19 onset, date of collection of a sample where SARS-CoV-2 was detected positive by PCR test, past medical history/curre... | [] |
NCT04642950 | 13.2 | Physical examination | 13.2 Physical examination The investigators will conduct physical examination (medical interview, inspection, palpation, and auscultation, etc.) according to the standard procedures of the medical institution, and the results will be recorded. Also, the date and the results of the examinations will be entered in the eC... | [] |
NCT04642950 | 13.3 | 7-point ordinal scale | 13.3 7-point ordinal scale The investigators will evaluate the category on a 7-point scale, referring to Table 13.3-1. The evaluation results will be recorded. Also, the date and the results of the evaluation will be entered in the eCRF. Category Ordinal scale 1 Have died 2 Use an invasive ventilator or ECMO 3 Use a no... | [] |
NCT04642950 | 13.4 | Vital signs | 13.4 Vital signs Blood pressure (systolic, diastolic), pulse rate, body temperature and respiratory rate will be measured and recorded. The date and the results of the measurements will be entered in the eCRF. Blood pressure and pulse rate will be measured after resting for about 5 minutes. The blood pressure may be me... | [] |
NCT04642950 | 13.5 | 12-lead Electrocardiography | 13.5 12-lead Electrocardiography Twelve-lead electrocardiography (ECG) will be performed after resting for at least 5 minutes in accordance with the standard procedure of the medical institution. The investigators or the designated, will confirm and assess the electrocardiogram, and record. The date of assessment, hear... | [] |
NCT04642950 | 13.6 | Laboratory tests (blood chemistry, hematology, urinalysis, and pregnancy test) | 13.6 Laboratory tests (blood chemistry, hematology, urinalysis, and pregnancy test) The following items will be measured at the medical institution. If the measurement results deviate from the reference value, the investigators will assess whether the deviation is clinically significant. Pregnancy test will be performe... | [] |
NCT04642950 | 13.7 | Percutaneous oxygen saturation (SpO2) | 13.7 Percutaneous oxygen saturation (SpO2) Percutaneous oxygen saturation (SpO2) will be measured using a pulse oximeter on breathing of room air in bed rest. The date and the test results will be entered in the eCRF | [] |
NCT04642950 | 13.8 | Inflammatory marker | 13.8 Inflammatory marker C-reactive protein (CRP) will be measured at the medical institution. The date of sample collection and the test results will be entered in the eCRF. | [] |
NCT04642950 | 13.9 | Cytokines | 13.9 Cytokines The following cytokines will be measured at the central laboratory. Measurement results will not be disclosed until the code breaking after the clinical study has been completed. The date of sample collection will be entered in the eCRF : IL-6, IL-1β, TNF-α, IL-10, CCL17, CXCL9, MMP-12. Sample collection... | [] |
NCT04642950 | 13.10 | Arterial blood gas analysis (PaO2, PaCO2, A-aDO2, others) | 13.10 Arterial blood gas analysis (PaO2, PaCO2, A-aDO2, others) The subject will take a rest for at least 5 minutes under breathing of room air (when oxygen is being inhaled, the device will be temporarily removed) in a supine position on bed in a physicians room or in an examination room, then SpO2 will be confirmed t... | [] |
NCT04642950 | 13.11 | Chest HRCT or plain chest CT or chest X-ray | 13.11 Chest HRCT or plain chest CT or chest X-ray Chest high-resolution computed tomography (HRCT), plain chest CT, or chest X-ray will be performed in each subject (or at each medical institution) by choosing one of the above-mentioned examinations, and the same examination will be performed throughout the study perio... | [] |
NCT04642950 | 13.12 | Oxygen requirement | 13.12 Oxygen requirement The investigators will evaluate the category of oxygen requirement of a subject classified in 5 categories, referring to Table 13.12-1. The date of evaluation and the results will be entered in the eCRF. Table 13.12-1 Oxygen Requirement | Category | Ordinal scale | |----------|-----------------... | [] |
NCT04642950 | 13.13 | Confirmation of AEs | 13.13 Confirmation of AEs If an AE is reported by a subject at any time during medical interview, or at voluntary visit, or on telephone contact, information on the name of the AE, date and time of onset, severity, seriousness, causality, treatment, outcome, and date of outcome will be obtained and recorded. In the cas... | [] |
NCT04642950 | 13.14 | Confirmation of concomitant medication/therapy | 13.14 Confirmation of concomitant medication/therapy Regarding concomitant medication, information on the name of the concomitant medication, route of administration, treatment duration, and reason for use of the concomitant medication will be recorded and entered in the eCRF. Regarding concomitant therapy, information... | [] |
NCT04642950 | 14 | AEs and adverse drug reactions (ADRs) | 14 AEs and adverse drug reactions (ADRs) | [] |
NCT04642950 | 14.1 | Definition of AE | 14.1 Definition of AE An AE is any unfavorable or unintended sign (including abnormal laboratory changes), symptom, or disease occurring in an assigned subject from the start of study drug administration, whether or not related to the study drug. Events occurring before the start of study drug administration will be tr... | [] |
NCT04642950 | 14.2 | Definition of ADR | 14.2 Definition of ADR ADR is at least reasonably likely to be related to the study drug and a causal relationship cannot be ruled out (see "14.6 Causality"). | [] |
NCT04642950 | 14.3 | Severity of AEs | 14.3 Severity of AEs The severity of an AE will be assessed by classifying the AE into three grades: mild, moderate, and severe, referring to the following criteria and Pharmaceutical Safety Notification No. 80 (June 29, 1992) "Criteria for Classification of Seriousness of Adverse Drug Reactions". Grades 1 ,2, and 3 de... | [
"■Criteria"
] |
NCT04642950 | 14.4 | SAEs | 14.4 SAEs The following AEs are defined as SAEs. Scheduled hospitalization for surgery or examination, educational hospitalization, hospitalization and prolongation of hospitalization due to the convenience of the home caregiver, hospitalization for disease control, and hospitalization for health care (medical examinat... | [] |
NCT04642950 | 14.5 | Significant AEs | 14.5 Significant AEs A significant AE is not an SAE, but is judged to be of special interest due to its clinical significance. A non-SAE leading to study drug discontinuation will be regarded as a significant AE. | [] |
NCT04642950 | 14.6 | Causality | 14.6 Causality The causal relationship between AE and study drug will be assessed as follows. If an AE is applicable to 2), the AE will be regarded as an ADR. - 1) Not related: The temporal sequence of the AE to the administration of the study drug is not reasonable, or there is another obvious cause including current ... | [] |
NCT04642950 | 14.7 | Predictability of AEs | 14.7 Predictability of AEs Of AEs (including ADRs previously reported to the MHLW), those of which nature, severity, or frequency, etc. cannot be predicted according to the Investigator's Brochure 2will be regarded as "unknown" and those which can be predicted will be regarded as "known". | [] |
NCT04642950 | 14.8 | Observation of AEs | 14.8 Observation of AEs The investigators shall observe the occurrence of AEs carefully through medical interview, medical examination, etc. from the start of study drug administration. If any AE is observed, appropriate measures should be taken, and the AE shall be followed up by the investigators until the AE disappe... | [] |
NCT04642950 | 14.9 | Pregnancy | 14.9 Pregnancy When a female subject has been known or suspected to be pregnant during the study period, the investigators shall immediately discontinue the study drug administration and shall report the prespecified information (at least subject identification code, date of acknowledgment of pregnancy, dates of start ... | [] |
NCT04642950 | 14.10 | Reporting of SAEs | 14.10 Reporting of SAEs | [] |
NCT04642950 | 14.10.1 | Principal investigator | 14.10.1 Principal investigator If an SAE occurs during the period from the start of study drug administration to Day 14, the investigators will take the necessary measures with the highest priority given to the safety of the subject, regardless of whether it is related to the study drug or not. The principal investigat... | [
"Emergency Contact (Sponsor)"
] |
NCT04642950 | 14.10.2 | Sponsor | 14.10.2 Sponsor The sponsor shall follow the following procedures when the occurrence of an SAE has been reported by the investigators. - (1) "Report on serious adverse event" shall be obtained at the earliest possible time within 7 days after the first announcement has been received from the investigators. - (2) The s... | [] |
NCT04642950 | 15 | Criteria for Discontinuation of Study, Subject and Study Drug | 15 Criteria for Discontinuation of Study, Subject and Study Drug | [] |
NCT04642950 | 15.1 | Study drug discontinuation | 15.1 Study drug discontinuation If the subject meets any of the following criteria at any time before the second dose on Day 5, study drug administration for the subject shall be discontinued. - (1) The subject has started to use invasive ventilator or ECMO. - (2) The WBC count of the subject exceeds 25,000/μL. - (3) A... | [
"[Rationale]"
] |
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