COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04403685

Viviane Veiga, MD

veigaviviane@yahoo.com.br

2020-05-27

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: male and females with 18 years and older confirmed diagnosis of sars-cov 2 infection more than 3 days of symptoms related to covid-19 computed tomography (or chest x-ray) with covid-19 alterations both of the criteria need for oxygen supplementation to keep spo2 > 93% or need for mechanical ventilation for less than 24 hours before the randomization at least two of the following inflammatory tests above the cutoff : d-dimer > 1,000 ng/ml reactive c protein > 5 mg/dl ferritin > 300 mg/dl lactate dehydrogenase > upper level limit

- need for mechanical ventilation for 24 hours or more before the randomization - hypersensitivity to tocilizumab - patients without therapeutic perspective or in palliative care - active non controlled infections - other clinical conditions that contraindicate tocilizumab, according to the assistant physician - low neutrophils count (< 0.5 x 109/l) - low platelets count (< 50 x 109/l) - liver disease, cirrhosis or elevated ast or alt above 5 times the upper level limit - renal disease with estimate glomerular filtration below 30 ml/min/1.72 m2 (mdrd or ckd-epi scores) - active diverticulitis - breastfeeding women - pregnancy

2

Beneficência Portuguesa de São Paulo

18

100

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

129

Evaluation of clinical status

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"}]