COVID-19
Conditions
Keywords
COVD-19, Tocilizumab, Respiratory infection, 20-185, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
Interventions
DRUGTocilizumab
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study. * COVID-19 PCR positive on nasopharyngeal swab * Aged \>/= 18 years old * Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate \>/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) \< 93% on room air for nonintubated pts. * Fever of 38.5 C or suspected respiratory infection * IL-6 level \>/= 80 pcg/ml * Cohort #1 - non intubated Cohort #2 - intubated * Women of childbearing potential must have a negative serum or urine pregnancy test * Patients receiving ongoing steroid therapy are eligible * Patients will be allowed to receive concurrent or sequential treatment with remdesivir
Exclusion criteria
* Patients with uncontrolled systemic fungal and bacterial infections * Patients with latent tuberculosis * Patients with known hypersensitivity to tocilizumab or any component of the formulation * Concurrent initiation of steroid therapy is not allowed * Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of Respiratory Failure or Death | 14 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 6 |
| Total | 9 |
Baseline characteristics
| Characteristic | Intubation/Mechanical Ventilation | Total | Respiratory Support |
|---|---|---|---|
| Age, Continuous | 68 years | 73 years | 74 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 3 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 3 | 3 / 6 |
| other Total, other adverse events | 3 / 3 | 6 / 6 |
| serious Total, serious adverse events | 1 / 3 | 3 / 6 |
Outcome results
Primary
Progression of Respiratory Failure or Death
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.
Time frame: 14 days
Population: Data were not collected