COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04482621

Franco D'Alessio, M.D

Not reported

2020-07-22

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: ≥18 years use of intermittent mechanical ventilation, non-invasive mechanical ventilation (nimv) or high flow nasal cannula. have ards or acute lung injury physiology confirmed by pao2/fio2 ratio of < 300 severe acute respiratory distress syndrome (sars) - coronavirus (cov-2) determined by lab polymerase chain reaction assay in either upper or lower respiratory tract sampling (e.g. bronchoalveolar lavage or nasopharyngeal swab) if childbearing age: agree to practice effective birth control from screening until at least 180 days after last dose

hematologic cytopenias: absolute neutrophil count (anc) <1500/mm3, hgb<7.0 and/or platelets <100,000/mm3 subjects receiving or enrolled in clinical trial for other investigational treatment for sars- 2-cov. active malignancy, solid tumors, and current or recent chemotherapy concomitant use of nonbiologic immunosuppressants (e.g. janus kinase (jak) inhibitors, bruton's tyrosine kinase (btk) inhibitors) active hiv viremia, or any other uncontrolled secondary infection. concurrent immunomodulating biologics or use of palifermin, dipyrone, deferiprone subjects with severe sepsis with vasopressors or extrapulmonary organ failure: aspartate aminotransferase (ast) / alanine aminotransferase (alt) /alkaline phosphatase (alk) phos ≥3x upper limit of normal (uln) and total bilirubin (tbili) ≥2x uln; or creatinine clearance <30 ml/min pregnant women or women who are breastfeeding any condition, per opinion of pi that would affect subject safety and/or compliance prior hypersensitivity to decitabine

2

Johns Hopkins University

18

100

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

33

Proportion of patients who are alive and free of respiratory failure at day 28

None

Phase 2

[{"arm_notes": "", "treatment_id": 386, "treatment_name": "Decitabine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]