Trial Outcomes & Findings for Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection (NCT NCT04377659)
NCT ID: NCT04377659
Last Updated: 2025-05-28
Results Overview
The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
14 days
Results posted on
2025-05-28
Participant Flow
Participant milestones
| Measure |
Intubation/Mechanical Ventilation
Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
Respiratory Support
In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Intubation/Mechanical Ventilation
n=3 Participants
Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
Respiratory Support
n=6 Participants
In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
74 years
n=7 Participants
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Data were not collected
The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.
Outcome measures
Outcome data not reported
Adverse Events
Intubation/Mechanical Ventilation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Respiratory Support
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intubation/Mechanical Ventilation
n=3 participants at risk
Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
Respiratory Support
n=6 participants at risk
In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
|---|---|---|
|
Vascular disorders
Thromboembolic Event
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/3 • 1 year
|
50.0%
3/6 • 1 year
|
|
Infections and infestations
Infecions and Infestations - Other, specify - Covid-19
|
0.00%
0/3 • 1 year
|
50.0%
3/6 • 1 year
|
Other adverse events
| Measure |
Intubation/Mechanical Ventilation
n=3 participants at risk
Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
Respiratory Support
n=6 participants at risk
In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
Tocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
|
|---|---|---|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • 1 year
|
16.7%
1/6 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • 1 year
|
66.7%
4/6 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • 1 year
|
33.3%
2/6 • 1 year
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
Additional Information
Dr. Boglarka Gyurkocza, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3768
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place