COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04361552

Ajay K Nooka

anooka@emory.edu

2020-04-24

Withdrawn

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - diagnosis with sars-cov-2 by the currently available assays (food and drug administration [fda] approved) - should be hospitalized and exhibit at least one of the following predictors of mortality - age >= 65 years - current smoker (smoked >= 100 cigarettes in life and actively smoking) - chronic obstructive pulmonary disease (copd) - diabetes - hypertension - coronary artery disease - cerebrovascular accident (cva) - chronic renal disease (creatinine of >= 2 mg/dl) - cancer - patients that have c-reactive protein (crp) >= 10 mg/l - d-dimer >= 0.5 mg/l - procalcitonin >= 0.5 mg/l - lactate dehydrogenase (ldh) >= upper limit of normal (uln) - patients or authorized family member willing to sign informed consent to participate in this study

- pregnant or lactating women - hypersensitivity to tocilizumab - patients or authorized family member unwilling to sign informed consent to participate in this study - uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)

2

Emory University

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

7-day length of invasive mechanical ventilation (MV);30-day mortality rate

None

Phase 3

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]