Trial · NCT07492888
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 28-day all-cause mortality | Day 28 (28 days after first dose) | Proportion of participants who die from any cause within 28 days of first study drug administration. |
| Primary | Treatment Emergent Adverse Events (TEAEs) | From first study treatment to 30 days after the participant's last study dose. | Any new or worsening medical event beginning after the first dose through 30 days post-last dose, collected to characterize overall tolerability. |
| Primary | Severe Adverse Events (SAEs) | From first study treatment to 30 days after the participant's last study dose (SAEs related to study product reported regardless of last dose date). | Events meeting regulatory seriousness criteria (death, life-threatening, hospitalization, disability, congenital anomaly or other medically important events) reported to evaluate major safety risks. |
| Primary | Grade ≥3 TEAEs | From first study treatment to 30 days after the participant's last study dose. | Adverse events of CTCAE severity grade 3 or higher that emerge after first dose, used to quantify severe toxicity burden. |
| Primary | Safety laboratory tests | From baseline (pre-dose) through 30 days after the participant's last study dose. | Routine clinical labs (CBC, chemistry, coagulation, etc.) collected serially to detect clinically meaningful laboratory abnormalities attributable to treatment. |
| Primary | Temperature | Baseline (pre-dose) through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion (vitals every ≥4 hours; continuous telemetry as indicated). | Serial core body temperature measured in degrees Celsius. Report baseline, maximum post-dose within 24 hours, and incidence of fever \>39.0°C. |
| Primary | Heart rate | Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days). | Serial heart rate (bpm). Report baseline, peak within 24 hours post-infusion, and incidence of new clinically significant tachycardia (\>120 bpm) requiring intervention. |
| Primary | Blood pressure | Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days). | Serial systolic/diastolic blood pressure (mmHg). Report baseline, nadir within 24 hours post-infusion, and incidence of new hypotension (MAP \<65 mmHg or need for new/increased vasopressor) temporally related to infusion. |
| Primary | Respiratory rate | Baseline (pre-dose); maximum post-dose within 24 hours after iNKT infusion (intensified monitoring during this 24-hour window); overall reporting through End of ICU stay (up to 28 days). | Serial RR (breaths/min). Report baseline, worst value within 24 hours post-infusion, and incidence of clinically significant tachypnea (RR ≥30) or new respiratory deterioration requiring escalation. |
| Primary | Oxygen saturation | Baseline through End of ICU stay; intensified monitoring for 24 hours after iNKT infusion. | Serial peripheral oxygen saturation (%). Report baseline, nadir within 24 hours post-infusion, and incidence of new hypoxemia (SpO2 \<90% on prior baseline support or increase in FiO2/ventilatory support). |
| Secondary | Absolute Lymphocyte Count (ALC) | Assessed at baseline and summarized at Days 7, 14, 21, and 28 after first dose. | Peripheral ALC measured over time to evaluate reversal of lymphopenia and quantitative immune recovery after treatment. |
| Secondary | Ventilator-free days (VFD) through Day 28 | Number of days within the 28-day window the participant is alive and free from mechanical ventilation, with death or ventilator dependence to Day 28 scored as zero. | From first study treatment through Day 28 after first dose. |
| Secondary | ICU-free days through Day 28 | From first study treatment through Day 28 after first dose. | Number of days within 28 days the participant is alive and not in ICU, reflecting time free from intensive care support. |
| Secondary | Antibiotic-free days through Day 28 | From first study treatment through Day 28 after first dose. | Number of days within 28 days the participant is alive and not receiving systemic antibiotics for respiratory infection, as a proxy for infection control and clinical recovery. |
| Secondary | Days alive and free of other organ support through Day 28 | From first study treatment through Day 28 after first dose. | Count of days within 28 days the participant is alive and not requiring non-respiratory organ supports (eg, vasopressors, renal replacement therapy), reflecting multi-organ recovery. |
| Secondary | Time to ICU discharge | From first study treatment (Day 1) through Day 28 - time to ICU discharge will be reported as days from first dose to date/time of ICU discharge; participants not discharged by Day 28 will be censored at Day 28. | Interval from first dose to date/time participant leaves ICU, used to assess speed of clinical improvement sufficient for lower-level care. |
| Secondary | Time to hospital discharge | From first study treatment (Day 1) through Day 28 - time to hospital discharge will be reported as days from first dose to date of hospital discharge; participants not discharged by Day 28 will be censored at Day 28. | From first study treatment until hospital discharge (if occurs). |
| Secondary | Number of secondary infections through Day 28 | From first study treatment through Day 28 after first dose. | Incidence and timing of new clinically documented infections (eg, ventilator-associated pneumonia, bloodstream infection) occurring within 28 days, to evaluate infection risk post-treatment. |
| Secondary | Number of secondary infections through participant follow-up | Incidence of new clinically documented infections up to 90 days to capture later-onset infectious complications. | From first study treatment through 90 days after first dose. |
| Secondary | 90-day all-cause mortality | From first study treatment to Day 90 after first dose. | Death from any cause occurring within 90 days of first treatment to evaluate longer-term survival. |
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.
For software
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