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

NCT04482621 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: IRB00247544IRB00521868
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

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

  The proportion of patients who are alive and free of respiratory failure at day 28 since start of randomization.

  From the day of randomization to day 28

Secondary Outcomes (11)

• Safety as assessed by adverse events

  Up to 6 weeks

• Change in oxygenation index

  Daily, up to 6 weeks

• Change in fraction of inspired oxygen

  Up to day 29

• Overall survival

  Up to 6 weeks

• Length of stay in hospital

  Till hospital discharge, up to 6 weeks

Study Arms (2)

Decitabine + Standard of Care (SOC)

ACTIVE COMPARATOR

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

Drug: Decitabine

Standard of Care (SOC) + Placebo

PLACEBO COMPARATOR

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

Other: Placebo Saline

Interventions

Decitabine DRUG

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)

Also known as: 5-aza-2'- deoxycytidine, DACOGEN

Decitabine + Standard of Care (SOC)

Placebo Saline OTHER

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

Standard of Care (SOC) + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

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MeSH Terms

Conditions

COVID-19

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Pali Shah, M.D

  Johns Hopkins UIniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 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.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 22, 2020
• Study Start: September 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)