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Decitabine for COVID-19 (DART Trial)

Phase 2
Waitlist Available
Led By Franco D'Alessio, M.D
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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
Concurrent immunomodulating biologics or use of Palifermin, Dipyrone, Deferiprone
Screening 3 weeks
Treatment Varies
Follow Up up to day 29
Awards & highlights


This trial is testing if the leukemia drug decitabine can help people with severe COVID-19. 40 people will be enrolled, half receiving decitabine and half receiving a placebo. The primary objective is to determine if decitabine is safe and effective for COVID-19 ARDS.

Who is the study for?
This trial is for adults over 18 with severe COVID-19 and ARDS, using mechanical ventilation or high-flow oxygen. They must have a lab-confirmed SARS-CoV-2 infection and agree to use birth control if of childbearing age. Excluded are those with certain organ failures, active cancers, blood disorders, other experimental treatments for COVID-19, uncontrolled infections like HIV, pregnant or breastfeeding women.Check my eligibility
What is being tested?
The DART Trial is testing the safety and effectiveness of Decitabine in treating critically ill COVID-ARDS patients. It's a Phase 2 study where participants get either Decitabine plus standard care or a saline placebo plus standard care. The main goal is to see if they improve on a clinical scale.See study design
What are the potential side effects?
Decitabine can cause side effects such as low blood cell counts leading to increased infection risk, bleeding problems, fatigue; it may also affect liver function tests and could potentially cause allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I use a machine to help with my breathing.
My lung function is severely impaired, as shown by a specific oxygen test.
I have tested positive for COVID-19 through a lab test.
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
My liver enzymes or bilirubin levels are very high, or my kidneys are not working well.
I am not currently taking any immune system modifying drugs or specific medications like Palifermin, Dipyrone, or Deferiprone.
I am currently receiving or have recently received chemotherapy for my solid tumor cancer.
I am not taking any nonbiologic immunosuppressants like JAK or BTK inhibitors.
I do not have active HIV or any uncontrolled infections.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who are alive and free of respiratory failure at day 28
Secondary outcome measures
All-cause mortality at 28 days since randomization
Change in fraction of inspired oxygen
Change in oxygenation index
+8 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Decitabine + Standard of Care (SOC)Active Control1 Intervention
Study drug Decitabine will be administered via Intravenous injection. Dosage Regimen: 10mg/m^2/day IV day x 5 days (1 cycle only)
Group II: Standard of Care (SOC) + PlaceboPlacebo Group1 Intervention
Saline based placebo will be administered via Intravenous injection. Dosage Regimen: 10mg/m^2/day IV day x 5 days (1 cycle only)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Decitabine, a DNA hypomethylating agent, is being studied for its potential to treat COVID-19-related acute respiratory distress syndrome (ARDS). DNA hypomethylation can reactivate suppressed genes that may help in modulating the immune response and reducing inflammation, which is crucial in managing severe COVID-19 cases. This matters for COVID-19 patients because controlling the hyperinflammatory response can prevent complications and improve outcomes. Broadly, common COVID-19 treatments include antiviral drugs that inhibit viral replication, immunomodulators that adjust the immune response, and supportive therapies to manage symptoms and prevent organ failure.
The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.Clinical Management of Diabetes Mellitus in the Era of COVID-19: Practical Issues, Peculiarities and Concerns.Evidence and the Main Adverse Effects Regarding Drug Therapies in the War Against COVID-19.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,843,032 Total Patients Enrolled
34 Trials studying COVID-19
26,928 Patients Enrolled for COVID-19
Franco D'Alessio, M.DPrincipal InvestigatorJohns Hopkins UIniversity

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04482621 — Phase 2
COVID-19 Research Study Groups: Decitabine + Standard of Care (SOC), Standard of Care (SOC) + Placebo
COVID-19 Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT04482621 — Phase 2
Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482621 — Phase 2
~1 spots leftby Sep 2024