COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04730323

Aijaz Zeeshan Khan Chachar

Not reported

2021-01-29

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: all patients diagnosed with covid-19 infection with positive reverse transcriptase rt-pcr test, willing to participate in this study or pcr negative patients with clinically covid-19 pneumonia in cytokine storm as evidenced by raised inflammatory markers with typical radiological changes patients of both genders were included patients having an age of > 65 years with proven cardiomyopathy, coronary artery disease, chronic lung disease, immunosuppressed or organ transplant end-stage renal disease on history & examination and medical records and having any 1 out of 4 fever 0f ≥39 c hypotension or drop in mean arterial pressure of > 10mmhg progressive hypoxemia requiring > 5 liters of oxygen sustained respiratory rate >30/min with any 2 laboratory parameters out of 3 are present d-dimers ≥ 1000 ng/ml c-reactive protein crp ≥ 100mg/l ferritin ≥ 600ng/ml patients having low risk or no comorbidities and having an age of <65 years with having any 3 out of 4 fever 0f ≥39 c hypotension or drop in mean arterial pressure of > 10mmhg progressive hypoxemia requiring > 5 liters of oxygen sustained respiratory rate >30/min with any 2 laboratory parameters out of 3 are present d-dimers ≥ 1000 ng/ml c-reactive protein crp ≥ 100mg/l ferritin ≥ 600ng/ml moderate severe or severe covid 19 features shortness of breath oxygen saturation <93% on room air progressive hypoxemia requiring > 5 liters of oxygen respiratory rate >30/min the partial pressure of arterial oxygen to fraction of inspired oxygen ratio<300 lung infiltrates on chest x-ray cxr >50% within 24 to 48 hrs respiratory failure

- known severe allergic reactions to tocilizumab or any other monoclonal antibody - pregnancy or breastfeeding - absolute neutrophil count(anc) < 1000 - alanine aminotransferase(alt) or aspartate aminotransferase (ast) > 5 times upper normal limit - platelet count of < 50,000 - bowel diverticulitis or bowel perforation - patients having acute pancreatitis

2

FMH College of Medicine and Dentistry

16

85

Pakistan

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

93

Decreased Mortality in Participants;Hospital & ICU stay in days

None

Phase 4

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]