COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04575610

Hyung Chun, MD

hyung.chun@yale.edu

2020-10-05

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria adult male and female patients, including women of childbearing potential, at least 18 years of age, inclusive participant (or legally authorized representative) capable of giving signed informed consent laboratory-confirmed novel coronavirus (sars-cov-2) infection clinical findings and an imaging study consistent with ards; pao2 / fio2 ratio < 300; a requirement for mechanical ventilation ≤ 48 hours prior to enrollment. evidence of increased inflammation as assessed by hscrp > uln and at least one of the following being > upper limit of normal (as available): ferritin procalcitonin d-dimer fibrinogen ldh pt/ptt exclusion criteria suspected or known active systemic bacterial, viral (except sars-cov2 infection), or fungal infections active herpes zoster infection known active or latent tuberculosis (tb) or history of inadequately treated tb active hepatitis b or hepatitis c known history of human immunodeficiency virus (hiv) infection with a detectable viral load or cd4 count < 500 cells / mm3 (patients for whom documented viral load or cd4 counts are available will be excluded) active hematologic cancer metastatic or intractable cancer pre-existing neurodegenerative disease severe hepatic impairment defined as child-pugh class b or class c at baseline severe renal impairment with an estimated glomerular filtration rate (egfr) < 45 ml/min/1.73 m2 severe anemia (hb < 8.0 g/dl) any of the following abnormal laboratory values: absolute lymphocyte count <250 cells/mm3 absolute neutrophil count (anc) <1000 cells/mm3 platelet count <50,000 cells/mm3 alt or ast > 5x uln, or other evidence of hepatocellular synthetic dysfunction or total bilirubin > 2x uln any other medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study prohibited concomitant therapy (see section 1.12.7.2) pregnancy (a negative urine or serum pregnancy test is required for inclusion) immunocompromised patients, patients with known immunodeficiencies or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine) anticipated survival < 72 hours as assessed by the investigator. participation in other clinical trials of investigational treatments for covid-19 known history of nephrolithiasis

None

2

Yale University

18

75

United States

Critical disease at enrollment

8: Critical disease at enrollment

7

All-cause mortality at Day 29

None

Phase 2

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