Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	28-day all-cause mortality	30 days after the last dose of study drug	Up to Day 28 from randomization. (Participants lost to follow-up before Day 28 will be censored at their last known date alive; participants alive on Day 28 will be censored at Day 28).
Secondary	ALC count	From randomization through 28 days following randomization.	Absolute Lymphocyte Count
Secondary	Ventilator-Free days (VFD) through Day 28.	Through 28 days following randomization.	The number of days a participant is free from mechanical ventilation.
Secondary	Number of ICU free days through Day 28.	Through 28 days following randomization.	The number of days a participant is free from being in the Intensive Care Unit.
Secondary	Number of antibiotic free days through Day 28.	Through 28 days following randomization.	The number of days a participant is free from antibiotic treatment.
Secondary	Number of days alive and free of organ support through 28 days.	Through 28 days following randomization.	The number of days a participant is alive and does not require organ support.
Secondary	Time from first administration of study drug to ICU discharge.	From first study drug administration until ICU discharge, assessed up to 90 days; ICU discharge date documented from medical record (participants not discharged by Day 90 censored at Day 90; deaths prior to discharge counted as competing events).	The duration from the first dose of study drug until the participant is discharged from the Intensive Care Unit.
Secondary	Time from first administration of study drug to hospital discharge.	From first study drug administration until hospital discharge, assessed up to 90 days; hospital discharge date documented from medical record (participants not discharged by Day 90 censored at Day 90; deaths prior to discharge counted as competing events	The duration from the first dose of study drug until the participant is discharged from the hospital.
Secondary	Incidence of secondary infections through Day 28 and for the entire study.	From randomization through 90 days following randomization.	The occurrence rate of infections that develop after the start of study treatment.
Secondary	90-day all-cause mortality.	Through 90 days following randomization.	Death from any cause.
Other	Treatment Emergent Adverse Events (TEAEs).	From first study drug administration through 30 days after the last study drug administration.	Any adverse event that occurred or worsened after the start of study treatment.
Other	Serious Adverse Events (SAEs).	From first study drug administration through 30 days after the last study drug administration, with related SAEs followed until resolution or stabilization.	Any adverse event that meets predefined serious criteria (e.g., fatal, life-threatening, requires hospitalization).
Other	Grade ≥3 TEAEs	From first study drug administration through 30 days after the last study drug administration.	Treatment emergent adverse events with a severity grade of 3 or higher, based on CTCAE Version 6.0 (or specified grading for CRS/ICANS).
Other	Safety laboratory tests	At screening, before first study drug administration, on Day 1, 3, 5, 7, 10, then every 3 days until end of ICU stay, at end of ICU stay, and at 28-day follow-up.	Results from various clinical laboratory assessments
Other	Heart rate	At screening; pre-dose and 30 min post-dose on Days 1, 3, and 10; daily during hospitalization (up to 10 days); every 4 h for 24 h after Day 3 iNKT infusion; at ICU discharge; and at Day 28 and Day 90 follow-up.	Resting heart rate measured by bedside monitor or manual pulse; recorded as the value closest to the scheduled assessment time (beats per minute, bpm).
Other	Systolic and diastolic blood pressure	At screening; pre-dose and 30 min post-dose on Days 1, 3, and 10; daily during hospitalization (up to 10 days); every 4 h for 24 h after Day 3 iNKT infusion; at ICU discharge; and at Day 28 and Day 90 follow-up.	Noninvasive cuff blood pressure or arterial line value if present; record systolic/diastolic (mmHg) nearest scheduled assessment.
Other	Respiratory rate	At screening; pre-dose and 30 min post-dose on Days 1, 3, and 10; daily during hospitalization (up to 10 days); every 4 h for 24 h after Day 3 iNKT infusion; at ICU discharge; and at Day 28 and Day 90 follow-up.	Respiratory rate measured by bedside monitor or counted manually over 60 seconds; record breaths per minute nearest scheduled assessment.
Other	Oxygen saturation (SpO2)	At screening; pre-dose and 30 min post-dose on Days 1, 3, and 10; daily during hospitalization (up to 10 days); every 4 h for 24 h after Day 3 iNKT infusion; at ICU discharge; and at Day 28 and Day 90 follow-up.	Peripheral oxygen saturation by pulse oximetry (%) on current supplemental oxygen; record SpO2 and concurrent FiO2/oxygen delivery method.
Other	Body temperature	At screening; pre-dose and 30 min post-dose on Days 1, 3, and 10; daily during hospitalization (up to 10 days); every 4 h for 24 h after Day 3 iNKT infusion; at ICU discharge; and at Day 28 and Day 90 follow-up.	Core or oral temperature measured per site standard (use same method consistently for a participant); record value in degrees Celsius (°C) nearest scheduled assessment.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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