Decitabine for COVID-19 (DART Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByPali 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.

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.

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

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.

Participant Groups

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.

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)

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dacogen for: