Decitabine for COVID-19

(DART Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Pali Shah, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins University

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if the drug decitabine can safely and effectively treat severe lung issues in critically ill COVID-19 patients. Patients will receive either decitabine or standard care. The goal is to see if decitabine helps improve their condition by reducing lung damage.

Research Team

Pali Shah, MD

Principal Investigator

Johns Hopkins UIniversity

Eligibility Criteria

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.

Inclusion Criteria

I use a machine to help with my breathing.

If childbearing age: agree to practice effective birth control from screening until at least 180 days after last dose

My lung function is severely impaired, as shown by a specific oxygen test.

Exclusion Criteria

My liver enzymes or bilirubin levels are very high, or my kidneys are not working well.

Any Condition, per opinion of PI that would affect subject safety and/or compliance

I am not currently taking any immune system modifying drugs or specific medications like Palifermin, Dipyrone, or Deferiprone.

Treatment Details

Interventions

• Decitabine (Anti-metabolites)
• Placebo Saline (Other)

Trial Overview 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.

Participant Groups

Group I: Decitabine + Standard of Care (SOC) Active Control 1 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) + Placebo Placebo Group 1 Intervention

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

Decitabine is already approved in Canada, Japan for the following indications:

Approved in Canada as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution