← Back to Search

Anti-metabolites

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 29
Awards & highlights

DART Trial Summary

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.

DART Trial Eligibility Criteria

Inclusion Criteria

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

DART Trial Timeline

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

DART 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)

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,604 Total Patients Enrolled
34 Trials studying COVID-19
26,943 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What malady is Decitabine + Standard of Care (SOC) typically employed to ameliorate?

"Decitabine + Standard of Care (SOC) is typically administered to individuals with intermediate-2 risk according to the International Prognostic Scoring System. It can also be employed for ipss high risk, refractory anemias, and anemia management."

Answered by AI

Are any enrollees currently being accepted into this research endeavor?

"This trial has ceased to accept new patients, as the most recent update was made on November 22nd 2022. If you are in search of other studies, there are 1,159 currently recruiting for Covid-19 and 102 accepting enrolment into Decitabine + Standard of Care (SOC) trials."

Answered by AI

Has the combination of Decitabine and Standard of Care (SOC) been endorsed by the Food & Drug Administration?

"Our team determined a score of 2 for the safety of Decitabine + Standard of Care (SOC) due to its Phase 2 trial status. This means that there is some evidence supporting the medication's security, but none evaluating its effectiveness."

Answered by AI

What are the desired outcomes of this medical experiment?

"The primary analysis of this trial, measured over a 28-day period from randomization, will assess the change in clinical state via an ordinal assessment scale. Secondary metrics to be examined include Ventilator Free Days (VFD), Time to Polymerase Chain Reaction Negativity (PCR NEG), and Change in Oxygenation Index (OI)."

Answered by AI

What is the aggregate tally of participants enrolled in this clinical study?

"Unfortunately, this trial is not currently accepting candidates. The study was initially posted on September 14th 2020 and the last update occurred on November 22nd 2022. If you are hunting for other medical trials, 1159 covid-19 studies and 102 Decitabine + Standard of Care (SOC) experiments are presently enrolling participants."

Answered by AI

Has Decitabine been previously evaluated in conjunction with SOC for therapeutic purposes?

"Currently, 102 clinical trials exploring Decitabine + Standard of Care (SOC) are underway worldwide. Of those studies, 15 have entered the third phase of research and Philadelphia is hosting the highest number thereof. However, there are 1,483 locations operating such trials in total."

Answered by AI
Recent research and studies
~7 spots leftby Mar 2025