Overview

Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial

Status:
Recruiting

Trial end date:
2022-03-01

Target enrollment:
0

Participant gender:
All

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 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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johns Hopkins University

Treatments:

Decitabine

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