Something Very Official

Source
Publicly Available
Added
16 Jun 2026
Contributor
System
Produced by
CDISC USDM E2J 0.62.0
Observational Study v1 USDM v4.0
Sponsor
ClinicalTrials.gov
Protocol ID
NCT12345678
ACME Pharma
AP1234
European Union
EU12345
Food & Drug Administration
IND12345
World Health Organisation
WHO12345

Downloads

Synopsis

A simple test

Study

Study type
Observational Study
Therapeutic area
Type 2 diabetes · Diabetes mellitus (disorder)
Indication
Indication 1 · Indication 2
Protocol version
1

Design

Design
Observational
Model
Parallel Study
Sub-type
Safety Study
Time perspective
Cross-Sectional Study
Sampling method
Equal Probability Sampling Method
Arms
2
Epochs
4

Participants

Planned enrolment
120
Planned completion
100
Sex
Female · Male
Healthy participants
Includes healthy participants
Cohorts
COHORT1 · COHORT2

Key dates

Design Approval
16 Dec 2022

Objectives and endpoints

Primary
The primary efficacy objective for this study is to evaluate the efficacy of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia
  • Primary
    Clinical status assessed using a 7-category ordinal scale at Day 28
Secondary
The secondary efficacy objective for this study is to evaluate the efficacy of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia over the age of 120
  • Secondary
    Time to clinical improvement (TTCI) defined as a National Early Warning Score 2 (NEWS2) of <=2 maintained for 24 hours
  • Secondary
    Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status

Estimands

EST1

Survival of all patients

Variable of interest: Clinical status assessed using a 7-category ordinal scale at Day 28
ICE Text Patients with out of range lab values before dosing will be excluded
ICE Text A second bad event
ICE Text A third bad thing
EST2

Something else

Variable of interest: Time to clinical improvement (TTCI) defined as a National Early Warning Score 2 (NEWS2) of <=2 maintained for 24 hours
ICE Text Something else bad

Eligibility

Inclusion 2

  1. 1
    Subjects shall be between 120 and 120
  2. 2
    Subjects shall be between 120 and 120

Exclusion 3

  1. 1
    Subjects has been treated with Drug A at any time in the past
  2. 2
    Pick up activity Demographics
  3. 3
    If the value is equal to 1234.0

No order is declared for these criteria, which USDM permits. Grouped by inclusion and exclusion, then by criterion number.

Study design

Arm Screening Screening Epoch Baseline Baseline Epoch Treatment Treatment Epoch Follow-Up Follow-Up Epoch
Active Substance Active Comparator Arm EL1 EL2 EL3 EL5 EL4
Placebo Placebo Control Arm EL1 EL2 EL5 EL3 EL4

When each stage starts and ends

EL1
StartsStudy Start
EndsScreened
EL2
StartsScreened
EndsRadomized
EL3
StartsRadomized
EndsCompleted treatment 1
EL5
StartsRadomized
EndsCompleted treatment 2
EL4
StartsTreated
EndsLeave Study

Interventions

Int Label 1

Experimental Intervention Pharmacologic Substance A

Int Desc 1

Admin 1 12 Milligram · Dental Route of Administration · Ten Days Per Month · The duration will approximately ### weeks.

Int Label 2

Placebo Pharmacologic Substance A

Int Desc 2

Admin 2 12 Milligram · Dental Route of Administration · Ten Days Per Month · The duration will vary

Schedule of Activities

7 visits 4 activities Planned duration: It will be approximately 36 weeks. Entry: Potential subject identified

Schedule of Activities — 7 visits

Activity Screening Baseline Treatment Treatment Follow-Up
Visit Screen Screening Baseline Treatment 15 min Day 14 Check opt In by subject Decision Day 28 Follow Up Day 42
Study day Day 1 ◆ Day 15 Day 29 Day 43
Window -4..0 hours -1..1 days -1..1 days -3..3 days
Demographics
Procedures Stress procedure · 6MWT
Weight optional a a
Optional activity
  1. a If the sea is red

◆ marks the fixed reference the other visits are counted from.

Protocol document

The full text of the protocol.

Sponsor Confidentiality Statement:

Full Title:

Something Very Official

Trial Acronym:

SIMPLE

Protocol Identifier:

AP1234

Original Protocol:

Version Number:

1

Version Date:

2022-12-16

Amendment Identifier:

4

Amendment Scope:

Global

Compound Codes(s):

Compound Name(s):

Trial Phase:

Short Title:

Something Brief

Sponsor Name and Address:

ACME Pharma, Somewhere, In a City, In a District, In a big state, 12345, France

Regulatory Agency Identifier Number(s):

NCT12345678, EU12345, IND12345, WHO12345

Spondor Approval Date:

2023-01-01

1 PROTOCOL SUMMARY

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1.1 Protocol Synopsis

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1.2 Trial Schema

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1.3 Schedule of Activities

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2 INTRODUCTION

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2.1 Purpose of Trial

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2.2 Summary of Benefits and Risks

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3 TRIAL OBJECTIVES, ENDPOINTS AND ESTIMANDS

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3.1 Primary Objectives

The primary efficacy objective for this study is to evaluate the efficacy of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia

Clinical status assessed using a 7-category ordinal scale at Day 28

The secondary efficacy objective for this study is to evaluate the efficacy of TCZ compared with placebo in combination with SOC for the treatment of severe COVID-19 pneumonia over the age of 120

Time to clinical improvement (TTCI) defined as a National Early Warning Score 2 (NEWS2) of <=2 maintained for 24 hours

Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status

4 TRIAL DESIGN

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4.1 Description of Trial Design

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4.1.1 Participant Input into Design

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4.2 Rationale for Trial Design

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4.2.1 Rationale for Comparator

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4.2.2 Rationale for Adaptive or Novel Trial Design

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4.2.3 Other Trial Design Considerations

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4.3 Access to Trial Intervention After End of Trial

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4.4 Start of Trial and End of Trial

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5 TRIAL POPULATION

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5.1 Selection of Trial Population

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5.2 Rationale for Trial Population

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5.3 Inclusion Criteria

Patients may be included in the study only if they meet all the following criteria:

1

Subjects shall be between 120 and 120

2

Subjects shall be between 120 and 120

5.4 Exclusion Criteria

Patients may be excluded in the study for any of the following reasons:

1

Subjects has been treated with Drug A at any time in the past

2

Pick up activity Demographics

3

If the value is equal to 1234.0

5.5 Lifestyle Considerations

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5.5.1 Meals and Dietary Restrictions

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5.5.2 Caffeine, Alcohol, Tobacco, and Other Habits

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5.5.3 Physical Activity

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5.5.4 Other Activity

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5.6 Screen Failures

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6 TRIAL INTERVENTION AND CONCOMITANT THERAPY

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6.1 Description of Trial Intervention

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6.2 Rationale for Trial Intervention

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6.3 Dosing and Administration

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6.3.1 Trial Intervention Dose Modification

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6.4 Treatment of Overdose

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6.5 Preparation, Handling, Storage and Accountability

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6.5.1 Preparation of Trial Intervention

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6.5.2 Handling and Storage of Trial Intervention

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6.5.3 Accountability of Trial Intervention

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6.6 Participant Assignment, Randomisation and Blinding

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6.6.1 Participant Assignment

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6.6.2 Randomisation

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6.6.3 Blinding and Unblinding

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6.7 Trial Intervention Compliance

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6.8 Concomitant Therapy

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6.8.1 Prohibited Concomitant Therapy

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6.8.2 Permitted Concomitant Therapy

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6.8.3 Rescue Therapy

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6.8.4 Other Therapy

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7 DISCONTINUATION OF TRIAL INTERVENTION AND PARTICIPANT WITHDRAWAL FROM TRIAL

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7.1 Discontinuation of Trial Intervention

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7.1.1 Criteria for Permanent Discontinuation of Trial Intervention

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7.1.2 Temporary Discontinuation or Interruption of Trial Intervention

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7.1.3 Rechallenge

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7.2 Participant Withdrawal from the Trial

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7.3 Lost to Follow-Up

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7.4 Trial Stopping Rules

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8 TRIAL ASSESSMENTS AND PROCEDURES

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8.1 Screening/Baseline Assessments and Procedures

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8.2 Efficacy Assessments and Procedures

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8.3 Safety Assessments and Procedures

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8.3.1 Physical Examination

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8.3.2 Vital Signs

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8.3.3 Electrocardiograms

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8.3.4 Clinical Laboratory Assessments

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8.3.5 Suicidal Ideation and Behaviour Risk Monitoring

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8.4 Adverse Events and Serious Adverse Events

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8.4.1 Definitions of AE and SAE

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8.4.2 Time Period and Frequency for Collecting AE and SAE Information

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8.4.3 Identifying AEs and SAEs

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8.4.4 Recording of AEs and SAEs

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8.4.5 Follow-up of AEs and SAEs

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8.4.6 Reporting of SAEs

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8.4.7 Regulatory Reporting Requirements for SAEs

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8.4.8 Serious and Unexpected Adverse Reaction Reporting

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8.4.9 Adverse Events of Special Interest

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8.4.10 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs

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8.5 Pregnancy and Postpartum Information

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8.5.1 Participants Who Become Pregnant During the Trial

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8.5.2 Participants Whose Partners Become Pregnant

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8.6 Medical Device Product Complaints for Drug/Device Combination Products

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8.6.1 Definition of Medical Device Product Complaints

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8.6.2 Recording of Medical Device Product Complaints

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8.6.3 Time Period and Frequency for Collecting Medical Device Product Complaints .

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8.6.4 Follow-Up of Medical Device Product Complaints

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8.6.5 Regulatory Reporting Requirements for Medical Device Product Complaints

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8.7 Pharmacokinetics

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8.8 Genetics

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8.9 Biomarkers

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8.10 Immunogenicity Assessments

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8.10.1 Medical Resource Utilisation and Health Economics

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9 STATISTICAL CONSIDERATIONS

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9.1 Analysis Sets

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9.2 Analyses Supporting Primary Objective(s)

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9.2.1 Statistical Model, Hypothesis, and Method of Analysis

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9.2.2 Handling of Intercurrent Events of Primary Estimand(s)

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9.2.3 Handling of Missing Data

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9.2.4 Sensitivity Analysis

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9.2.5 Supplementary Analysis

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9.3 Analysis Supporting Secondary Objective(s)

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9.4 Analysis of Exploratory Objective(s)

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9.5 Safety Analyses

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9.6 Other Analyses

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9.7 Interim Analyses

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9.8 Sample Size Determination

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9.9 Protocol Deviations

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10 GENERAL CONSIDERATIONS: REGULATORY, ETHICAL, AND TRIAL OVERSIGHT

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10.1 Regulatory and Ethical Considerations

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10.2 Committees

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10.3 Informed Consent Process

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10.4 Data Protection

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10.5 Early Site Closure or Trial Termination

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11 GENERAL CONSIDERATIONS: RISK MANAGEMENT AND QUALITY ASSURANCE

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11.1 Quality Tolerance Limits

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11.2 Data Quality Assurance

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11.3 Source Data

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12 APPENDIX: ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS - DEFINITIONS, SEVERITY, AND CAUSALITY

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12.1 Further Details and Clarifications on the AE Definition

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12.2 Further Details and Clarifications on the SAE Definition

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12.3 Severity

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12.4 Causality

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13 APPENDIX: DEFINITIONS AND SUPPORTING OPERATIONAL DETAILS

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13.1 Contraception and Pregnancy Testing

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13.1.1 Definitions Related to Childbearing Potential

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13.1.2 Contraception

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13.1.3 Pregnancy Testing

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13.2 Clinical Laboratory Tests

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13.3 Country/Region-Specific Differences

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13.4 Prior Protocol Amendments

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14 APPENDIX: GLOSSARY OF TERMS

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15 APPENDIX: REFERENCES

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Conformance CDISC CORE CDISC Open Rules Engine No issues reported 207 rules 191 passed 16 not evaluated Engine 0.15.0 USDM v4.0 rules Run 16 Jun 2026

CDISC CORE

CDISC Open Rules Engine
No issues reported 207 rules 191 passed 16 not evaluated Engine 0.15.0 USDM v4.0 rules Run 16 Jun 2026
JSON report Excel report

Not evaluated 16

14 skipped · 2 engine errors 16 rules
  • DDF00046 Engine error The relative to/from scheduled instance of a timing was not defined within the same timeline as the timing: the parent_id of the scheduled instance ($parent_of_scheduled_instance) is not the same as parent_id of the timing (parent_id.Timing). Failed to execute rule operation. Operation: distinct, Target: parent_id, Domain: ScheduledDecisionInstance, Error: single positional indexer is out-of-bounds
  • DDF00141 Engine error The planned sex is not specified using the Sex of Participants (C66732) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist. Failed to execute rule operation. Operation: codelist_extensible, Target: None, Domain: StudyCohort, Error: You are trying to merge on object and float64 columns for key 'codeSystemVersion'. If you wish to proceed you should use pd.concat
  • DDF00014 Skipped The biomedical concept category does not have any members or children.
  • DDF00090 Skipped The biomedical concept category is referenced more than once from the same activity.
  • DDF00179 Skipped The administrable dose form is not specified according to the extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00180 Skipped The administrable product property type is not specified according to the extensible administrable product property type (C215479) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00199 Skipped The study impact type is not specified according to the extensible study amendment impact type (C215481) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00207 Skipped The medical device identifier type is not specified according to the extensible medical device identifier type (C215484) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00208 Skipped The administrable product sourcing is not specified according to the extensible administrable product sourcing (C215483) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00209 Skipped The medical device sourcing is not specified according to the extensible medical device sourcing (C215482) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00210 Skipped The administrable product's product designation is not specified using the product designation (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
  • DDF00214 Skipped The interventional study design's intent type is not specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00215 Skipped The interventional study design's sub type is not specified according to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00216 Skipped The study design's intervention model is not specified according to the extensible Intervention Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00217 Skipped The study design's blinding schema is not specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
  • DDF00229 Skipped The study design's study phase is not specified according to the extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).

This protocol was contributed by a third party and has not been verified. Provided for informational and standards-development purposes only — see the Disclaimer & Terms of Use.