Clinical trial

Decitabine for COVID-19 Pneumonia-ARDS Treatment: DART Trial

Name

IRB00247544

Description

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 assess efficacy of decitabine in the treatment of critically ill patients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receive standard of care plus Decitabine or standard of care plus saline based placebo. The primary objective is to determine safety and efficacy of decitabine for COVID-19 ARDS based on clinical improvement on a 6-point clinical scale.

Trial arms

Trial start

2020-09-14

Estimated PCD

2024-09-01

Trial end

2025-03-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Decitabine

Study duration is 6 weeks after the last dose of study drug. Number of study visits is dependent on Length of hospitalization of study participant. Study visits are scheduled on days 0-7, 11, 15, 29, and may occur via telemedicine or inpatient assessment or outpatient assessment in COVID recovered participants. Decitabine will be administered via Intravenous Administration 10/mg/m\^2/day Dosage: 10mg/m\^2/day IV day x 5 days (1 cycle only)

Arms:

Decitabine + Standard of Care (SOC)

Other names:

5-aza-2'- deoxycytidine, DACOGEN

Placebo Saline

Saline based placebo will be administered via Intravenous injection. Dosage Regimen: 10mg/m\^2/day IV day x 5 days (1 cycle only)

Arms:

Standard of Care (SOC) + Placebo

Size

Primary endpoint

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

From the day of randomization to day 28

Eligibility criteria

Inclusion Criteria: 1. ≥18 years 2. Use of Intermittent Mechanical Ventilation, non-invasive mechanical ventilation (NIMV) or High Flow Nasal Cannula. 3. Have ARDS or Acute Lung Injury physiology confirmed by Pao2/Fio2 ratio of \< 300 4. 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) 5. If childbearing age: agree to practice effective birth control from screening until at least 180 days after last dose Exclusion Criteria: 1. Hematologic cytopenias: Absolute Neutrophil Count (ANC) \<1500/mm3, Hgb\<7.0 and/or platelets \<100,000/mm3 2. Subjects receiving or enrolled in clinical trial for other investigational treatment for SARS- 2-CoV. 3. Active malignancy, solid tumors, and current or recent chemotherapy 4. Concomitant use of nonbiologic immunosuppressants (e.g. Janus Kinase (JAK) inhibitors, Bruton's Tyrosine Kinase (BTK) inhibitors) 5. Active HIV viremia, or any other uncontrolled secondary infection. 6. Concurrent immunomodulating biologics or use of Palifermin, Dipyrone, Deferiprone 7. Subjects with severe sepsis with vasopressors or extrapulmonary organ failure: 8. 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 9. Pregnant women or women who are breastfeeding 10. Any Condition, per opinion of PI that would affect subject safety and/or compliance 11. Prior hypersensitivity to decitabine

Protocol

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Updated at

2024-03-28

1 organization

Organization

Johns Hopkins University