COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05013034

mohanakrishnan sathyamoorthy, md

m.sathyamoorthy@tcu.edu

2021-08-19

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: subject inclusion criteria patient or legally authorized representative (lar) willing and able to provide written or electronic or otherwise fda-acceptable informed consent based on current fda regulations. hospitalized male or non-pregnant female rt-pcr confirmed sars-cov-2 using who consensus or validated primers meet the following criteria: deficiency in oxygenation as defined by the berlin ards criteria (27): timing: within 1 week of onset of symptoms imaging: bilateral pulmonary infiltrates oxygenation (any): mild: 200 mmhg < pao2/fio2 ≤ 300 mmhg moderate: 100 mmhg < pao2/fio2 ≤ 200 mmhg severe: pao2/fio2 ≤ 100 mmhg and requiring oxygen support in the form of high flow nasal cannula (hfnc), non-invasive positive pressure ventilation, intubation and mechanical ventilation, or initiation of ecmo and any one or more of the following: elevated crp (>10 gm/dl) elevated ferritin (>1000) neutrophil/lymphocyte ratio >3.3 patient will receive current clinical standard of care. this includes inpatient use of remdesivir, dexamethasone, convalescent plasma, or pre-hospitalization outpatient treatment with casirivimab and imdevima age ≥ 18 years

off label use of other drugs wocbp unwilling to use acceptable birth control for 5 weeks, or male partner of a wocbp unwilling to use male barrier method (condom) plus effective second method birth control for partner pregnant women pancytopenia hgb< 8 g/dl (male) or < 7 g/dl (female) wbc<2.0 x 109/l plt< 50 x 109/l 4) enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. 6) known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the sars-cov-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab. 7) any patient with multi-organ system failure or on intravenous vasopressor support 8) do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation

2

Fort Worth Clinical Sciences Working Group

18

100

None

Moderate disease at enrollment

3: Moderate disease at enrollment

300

Primary Efficacy Endpoint

None

Phase 2

[{"arm_notes": "", "treatment_id": 1834, "treatment_name": "Basiliximab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]