NCT04320615 · Consolidated SoA

Activities:

Near match across tables

Near match, different parent

| Annotations:

³ click for the text

in Unified Annotations: show where it applies

| Cells:

Common

▼ Main Schedule (35 columns)

Activity

Table 1

Table 2

Table 3

Study Period
[epoch] L1

Screening^2,3

Baseline

Days 3–28²³

Study Completion/Discontinuation

²⁵

Study Completion

Study Day
[study_day] L2

−2 to 0

35 (±3 days)

45 (±3 days)

60 (±3 days)

Time Post Initial Treatment (Assessment Window)
[timepoint] L3

0 Pre-dose (−4 hrs)

15 min After end of infusion (+1 hr)

24 hrs (±4 hrs)

36 hrs (±4 hrs)

Informed consent

Inclusion/exclusion criteria

Demographic data

Randomization

Medical history

Complete physical examination⁴

Weight

COVID-19 diagnosis⁵

Chest X-ray/CT scan⁶

T1,T2,T3

ECG

Pregnancy test⁷

PaO2/FiO2⁸

T1,T2

← Optional →

Optional

SpO2^9,24,27

T1,T2,T3

Vital signs^9,24,27

T1,T2,T3

Ordinal scoring¹⁰

T1,T2,T3

Adverse events¹¹

T1,T2,T3

Concomitant medications¹²

T1,T2,T3

Hematology^13,28

T1,T2,T3

Chemistry^14,29

T1,T2,T3

Study drug administration¹⁵

Central Labs

T1,T2,T3

Serum PD (CRP, IL-6, sIL-6R)

T1,T2,T3

x¹⁶

Serum PK¹⁷

T1,T2,T3

x¹⁸

Serum sample for exploratory biomarkers

T1,T2,T3

SARS-CoV-2 viral load^19,26

T1,T2,T3

Serum SARS-CoV-2 antibody titer

T1,T2,T3

Cryopreserved PBMCs²⁰

T1,T2

Whole blood in PAXgene® tubes for RNA analyses²¹

T1,T2

▼ Matches across tables all 1 decided

Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT04320615_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.

state	row	consolidation	other row	activity	decision
decided · ccorr-001 keep	T3 act-014 Serum SARS-Cov-2 antibody titer	merged with 1.00	T1 act-026 Serum SARS-CoV-2 antibody titer	xact-026	Case only. Kerstin Forsberg, 2026-10-04T08:20:00Z

Draft — entries to append to consolidated/NCT04320615_consolidation_corrections.json; replace each <why>, then re-run consolidation.

▼ Consolidation Metadata Process information

consolidated_at	2026-10-04T08:21:21.351351+00:00
source_activity_count	59
unified_activity_count	28
compression_percent	53
match_stats	exact: 30, fuzzy_auto: 1, new: 28

▼ Source Tables 3 tables

table	type	title / purpose	acts	cols	props
T1	main_soa	Appendix 1 Schedule of Activities: Days 1 and 2 Screening, baseline and Day 1-2 (initial treatment) schedule	28	5	3
T2	main_soa	Appendix 2 Schedule of Activities: Days 3–28 Daily in-hospital/follow-up schedule Days 3-28 plus Study Completion/Discontinuation	17	27	2
T3	main_soa	Appendix 3 Schedule of Activities: After Day 28 Post-Day-28 follow-up visits (Days 35, 45) and Day 60 Study Completion	14	3	2

▼ Property Hierarchy Comparison 3 main timeline tables, 3 levels max

Compares main timeline tables only (main_soa, continuation, subsidiary). Track, domain, and reference tables excluded — different structure by design.

Level	T1	T2	T3	Conclusion
L1	Study Period [epoch] Top header band with an empty label cell: 'Screening' over column 2, 'Baseline' over column 3, and an unlabelled merged blank cell over columns 4-6. Screening/Baseline are study-phase names, so typed epoch; name synthesized. Also anchors the table-wide 'Note:' (synthesized marker tn1).	Period [period] Top header band with an empty label cell: 'Days 3–28' (marker a) merged across columns 2-27 and 'Study Completion/Discontinuation' over column 28. Groups the daily columns into a follow-up period versus the completion/discontinuation visit; typed period; name synthesized. Also anchors the table-wide 'Note:' (synthesized marker tn1).	Visit [visit] Top header band with an empty label cell: a blank cell merged over columns 2-3 and 'Study Completion' over column 4. Names the Day 60 visit; typed visit; name synthesized.	≠ Differs
L2	Study Day [study_day] Protocol study days: '−2 to 0' (screening), Day 1 merged over columns 3-4, Day 2 merged over columns 5-6.	Study Day [study_day] Protocol study days 3 to 28, one per column (columns 2-27); empty under the Study Completion/Discontinuation column.	Study Day (Assessment Window) [study_day] Protocol study days 35, 45 and 60, each with a ±3 days window printed in the same cell; Days 35 and 45 carry marker a. Typed study_day.	≈ Same type
L3	Time Post Initial Treatment (Assessment Window) [timepoint] Within-day timepoints relative to the initial infusion with their assessment windows (0 pre-dose −4 hrs; 15 min after end of infusion +1 hr; 24 hrs ±4 hrs; 36 hrs ±4 hrs). Typed timepoint; the window is part of the printed cell text. Empty for the screening column.	—	—	1/3 tables

▼ Unified Activities 28 activities

xact_id	activity_name (variations)	parent	match	#	tables	row kind
xact-001	Informed consent		one table	1	T1
xact-002	Inclusion/exclusion criteria		one table	1	T1
xact-003	Demographic data		one table	1	T1
xact-004	Randomization		one table	1	T1
xact-005	Medical history		one table	1	T1
xact-006	Complete physical examination		one table	1	T1
xact-007	Weight		one table	1	T1
xact-008	COVID-19 diagnosis		one table	1	T1
xact-009	Chest X-ray/CT scan		same name	3	T1, T2, T3
xact-010	ECG		one table	1	T1
xact-011	Pregnancy test		one table	1	T1
xact-012	PaO2/FiO2		same name	2	T1, T2
xact-013	SpO2		same name	3	T1, T2, T3
xact-014	Vital signs		same name	3	T1, T2, T3
xact-015	Ordinal scoring		same name	3	T1, T2, T3
xact-016	Adverse events		same name	3	T1, T2, T3
xact-017	Concomitant medications		same name	3	T1, T2, T3
xact-018	Hematology		same name	3	T1, T2, T3
xact-019	Chemistry		same name	3	T1, T2, T3
xact-020	Study drug administration		one table	1	T1
xact-021	Central Labs		same name	3	T1, T2, T3	section
xact-022	Serum PD (CRP, IL-6, sIL-6R)	Central Labs	same name	3	T1, T2, T3
xact-023	Serum PK	Central Labs	same name	3	T1, T2, T3
xact-024	Serum sample for exploratory biomarkers	Central Labs	same name	3	T1, T2, T3
xact-025	SARS-CoV-2 viral load	Central Labs	same name	3	T1, T2, T3
xact-026	Serum SARS-CoV-2 antibody titer ≈ Serum SARS-Cov-2 antibody titer	Central Labs	near match, accepted	3	T1, T2, T3
xact-027	Cryopreserved PBMCs	Central Labs	same name	2	T1, T2
xact-028	Whole blood in PAXgene® tubes for RNA analyses	Central Labs	same name	2	T1, T2

▼ Unified Annotations 29 annotations (29% dedup from 41)

Footnote (29)

xannot_id	markers	#	text	scope	points to
xannot-001 1	T1:tn1	1	Note: On treatment days, all assessments should be performed prior to dosing, unless otherwise specified.	table
xannot-002 2	T1:a	1	Results from standard-of-care tests or examinations performed prior to obtaining informed consent and within 48 hours before randomization may be used; such tests do not need to be repeated for screening.	−2 to 0
xannot-003 3	T1:b	1	Informed consent must be documented before any study-specific screening procedure is performed.	−2 to 0
xannot-004 4	T1:c	1	A complete physical examination, performed at screening and per the investigator’s discretion during the study, includes an evaluation of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatologic, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurologic systems. Any abnormality identified at screening should be recorded on the General Medical History and Baseline Conditions eCRF. New or worsened clinically significant abnormalities identified during the study should be reported as adverse events.	Complete physical examination
xannot-005 5	T1:d	1	COVID-19 test (SARS-CoV2 PCR) to confirm diagnosis should be performed within 7 days of randomization.	COVID-19 diagnosis
xannot-006 6	T1:e	1	Screening chest X-ray or CT scans should be performed within 48 hours prior to randomization. If additional chest X-rays/CT scans are taken per local practice during the study, this information should be provided in the eCRF.	Chest X-ray/CT scan
xannot-007 7	T1:f	1	For women of childbearing potential, including those who have had a tubal ligation, positive urine test results will be confirmed with a serum pregnancy test. Study drug infusion must not be administered unless the serum pregnancy test result is negative.	Pregnancy test
xannot-008 8	T1:g, T2:c	2	If arterial blood gases are measured.	PaO2/FiO2
xannot-009 9	T1:h	1	All vital sign measurements (i.e., respiratory rate, pulse rate, systolic and diastolic blood pressures, and body temperature), oxygen saturation and NEWS2-specific assessments (i.e., consciousness and presence or absence of oxygen support) should be recorded together twice daily with approximately 12 hours in between while the patient remains hospitalized. If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF.	SpO2 \| Vital signs
xannot-010 10	T1:i, T2-3:d	3	Assessment of clinical status using the ordinal scale should be recorded at baseline on Day 1/Visit 1 then again daily every morning (between 8 am and 12 pm) for patients who remain hospitalized.	Ordinal scoring
xannot-011 11	T1:j, T2-3:e	3	After informed consent has been obtained but prior to initiation of study drug, only serious adverse events caused by a protocol-mandated intervention should be reported. After initiation of study drug, all adverse events will be reported until 60 days after the final dose of study drug. After this period, the Sponsor should be notified if the investigator becomes aware of any serious adverse event that is believed to be related to prior study drug treatment (see Section 5.6).	Adverse events	Section 5.6
xannot-012 12	T1:k, T2-3:f	3	Medication (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) used by a patient in addition to protocol-mandated treatment from 7 days prior to initiation of study drug to the study completion/discontinuation visit.	Concomitant medications
xannot-013 13	T1:l, T2:g	2	Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes), and lymphocyte subsets (T cells, B cells, and NK cells; if the test is available at the site).	Hematology
xannot-014 14	T1:m, T2:h	2	Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphorus, calcium, total bilirubin, ALP, ALT, and/or AST, uric acid, LDH, ferritin, and D-dimer.	Chemistry
xannot-015 15	T1:n	1	Study drug should be administered after collection of all samples for pharmacodynamic and exploratory biomarker analyses. The initial study drug infusion should be given within 4 hours of randomization. If the clinical signs or symptoms worsen or do not improve (reflected by sustained fever or at least a one-category worsening on the 7-category ordinal scale of clinical status), one additional infusion of blinded treatment of TCZ or placebo can be given, 8–24 hours after the initial infusion.	Study drug administration
xannot-016 16	T1:o	1	On Day 1, CRP, IL-6, and sIL-6R samples should be drawn 0–4 hours before the start of infusion and then within 15 minutes (to 1 hour) after the end of the infusion, on the opposite arm as the infusion. Patents receiving a second infusion of study drug should provide extra samples for CRP, IL-6, and sIL-6R prior to and 15 minutes after the end of the infusion, on the opposite arm as the infusion.	Serum PD (CRP, IL-6, sIL-6R) 2 cells
xannot-017 17	T1:p	1	Patents receiving a second infusion of study drug should provide an extra PK sample prior to and 15 minutes (to 1 hour) after the end of the infusion, on the opposite arm as the infusion.	Serum PK
xannot-018 18	T1:q	1	On Day 1, PK samples should be drawn 0–4 hours before the start of infusion and then within 15 minutes (to 1 hour) after the end of the infusion, on the opposite arm as the infusion.	Serum PK 2 cells
xannot-019 19	T1:r, T2:i	2	Viral load will be assessed by nasopharyngeal swab. Patients who are intubated and undergo bronchoalveolar lavage will have samples taken for virological assessment. It may only be possible to access one nostril if a patient has a nasogastric tube in place, in which case sites may collect a sample from one nostril only and where possible the same nostril should be used.	SARS-CoV-2 viral load
xannot-020 20	T1:s, T2:j	2	For sites capable of sample collection for analysis of T cells by high-dimensional cytometry.	Cryopreserved PBMCs
xannot-021 21	T1:t, T2:k	2	The first draw of blood should not be for PAXgene® tubes to avoid contact with RNA preservation reagent inside the tube.	Whole blood in PAXgene® tubes for RNA analyses
xannot-022 22	T2:tn1	1	Note: For patients who have been discharged, all assessments should be performed within ±3 days of the scheduled onsite visit.	table
xannot-023 23	T2:a	1	If patients are discharged from hospital prior to Day 28, follow-up visits should occur twice weekly through Day 28. Patients are encouraged to return for onsite visits at least weekly if possible; other follow-up visits may be conducted by telephone or home visits. Patients should return to the site for a Day 28 visit.	3 \| 4 \| 5 \| 6 \| 7 (+21)
xannot-024 24	T2:b	1	All vital sign measurements (i.e., respiratory rate, pulse rate, systolic and diastolic blood pressures, and body temperature), oxygen saturation and NEWS2-specific assessments (i.e., consciousness and presence or absence of oxygen support) should be recorded together twice daily with approximately 12 hours in between while the patient remains hospitalized. If measured more than once during a 12-hour period, the worst values (highest temperature, respiratory rate, and heart rate; lowest blood pressure, oxygen saturation, and consciousness level) during that period should be recorded on the eCRF. Following hospital discharge these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone.	Vital signs \| SpO2
xannot-025 25	T3:a	1	If patients are unable to return for onsite visits at Day 35 and/or Day 45, these may be conducted by telephone or home visits. Patients should return to the site for a Day 60 Study Completion visit.	35 (±3 days) \| 45 (±3 days)
xannot-026 26	T3:b	1	Patients who remain in hospital will have viral load assessed by nasopharyngeal swabs; these will be done if there is evidence of on-going infection.	SARS-CoV-2 viral load
xannot-027 27	T3:c	1	For patients who remain in hospital, vital sign measurements and NEWS2-specific assessments should be conducted twice daily. Following hospital discharge, these parameters should be recorded once at each return visit to the clinic. Vital signs and oxygen saturation will not be recorded if follow-up visits are conducted by telephone.	Vital signs \| SpO2
xannot-028 28	T3:g	1	Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes), and lymphocyte subsets (T cells, B cells, and NK cells). Hematology labs will not be performed if follow-up visits are conducted by telephone.	Hematology
xannot-029 29	T3:h	1	Chemistry panel (serum or plasma) includes bicarbonate or total carbon dioxide (if considered standard of care for the region), sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphorus, calcium, total bilirubin, ALP, ALT, and/or AST, uric acid, LDH, ferritin, and D-dimer. Chemistry labs will not be performed if follow-up visits are conducted by telephone.	Chemistry

NCT04320615 — consolidated Schedule of Activities