Status:
SUSPENDED
Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial
Lead Sponsor:
Johns Hopkins University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a total of 40 patients) to...
Detailed Description
This is a randomized double blind placebo controlled Phase 2 trial with a 12 patient lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a total of 40 patients) to a...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04482621
Start Date
September 14 2020
End Date
December 1 2026
Last Update
August 29 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287