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COVID-19Phase 2DARTNCT04482621

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

A Phase 2 study testing Decitabine in people with COVID-19, run by Johns Hopkins University at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Decitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited States
Study dates
14 Sep 2020to Dec 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Decitabine for COVID-19 Pneumonia-ARDS Treatment: DART Trial

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.

Read the detailed description

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.

Eligible patients will receive decitabine 10 mg/m2 daily for 5 days, 1 cycle only. This is a dose that is half the FDA approved dose for myelodysplastic syndrome (MDS), and using a single cycle.

If less than 2 of the first 6 (treatment arm) patients experience an unacceptable toxicity, defined as any treatment related grade III or higher adverse events, as per section 5.7, within 15 days of initiation of treatment, the drug is safe to continue. If the investigators observe more than 33% patients with unacceptable toxicity, the investigators will pause the accrual pending safety evaluation. After validating safety, the investigators will enroll additional 28 patients towards the primary efficacy endpoint. The investigators will monitor safety throughout the trial by monitoring clinical hematologic, chemistry, vital signs, respiratory parameters, medications, and clinical changes daily as per the schedule of procedures.

Bio samples from peripheral blood mononuclear cell (PBMC) and Mini Bronchoalveolar lavage (BAL) will be collected and stored for secondary analysis and mini BAL will only be collected as an optional sub-study for patient consented to a separate study protocol either at time-point of for-cause clinically indicated bronchoscopy, or for subjects consented to a separate Bronchoalveolar lavage (BAL) interventional study, under the auspices of that protocol. For research bio specimens required after study drug initiation, a window period of +/-24 hours while inpatient, and +/- 4 days for outpatient monitoring will be permitted.

These objectives will allow for the planning of subsequent phase 3 studies, and strengthen implementation of a multi-center randomized trial should this study confirm safety, and suggest efficacy of therapy.

Conditions
COVID-19
Being tested
Decitabine, Placebo Saline
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecitabineDrug

    Also called 5-aza-2'- deoxycytidine, DACOGEN

    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)

  • Placebo SalineOther

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

Study groups in NCT04482621
Study groupRoleWhat they receive
Decitabine + Standard of Care (SOC)Active comparatorStudy drug Decitabine will be administered via Intravenous injection. Dosage Regimen: 10mg/m^2/day IV day x 5 days (1 cycle only)
Receives: Drug: Decitabine
Standard of Care (SOC) + PlaceboPlacebo comparatorSaline based placebo will be administered via Intravenous injection. Dosage Regimen: 10mg/m^2/day IV day x 5 days (1 cycle only)
Receives: Other: Placebo Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the day of randomization to day 28

Secondary outcomes (11)

  1. Safety as assessed by adverse events

    Safety assessments using adverse events will be monitored daily while inpatient and weekly through end of study at week 6 once discharged from hospital. They will be monitored and graded using Common Terminology Criteria Adverse Events version 5.0.

    Measured: Up to 6 weeks

  2. Change in oxygenation index

    Oxygenation index is used to assess severity of hypoxic respiratory failure. (OI = mean airway pressure (MAP) × Fraction of inspired oxygen (FiO2) × 100÷ partial pressure of oxygen (PaO2). This will be measured daily while subject is on mechanical ventilation up to 6 weeks.

    Measured: Daily, up to 6 weeks

  3. Change in fraction of inspired oxygen

    Fraction of inspired oxygen in the oxygen delivery system during hospital stay. Measured at 8 am daily during hospital stay and then weekly until day 29.

    Measured: Up to day 29

  4. Overall survival

    Patients status of alive versus death at completion of study follow up period, i.e. 6 weeks from start.

    Measured: Up to 6 weeks

  5. Length of stay in hospital

    Duration of days from baseline to hospital discharge.

    Measured: Till hospital discharge, up to 6 weeks

  6. Ventilator free days

    For subjects who received mechanical ventilation, total number of days from baseline to end of study at 6 weeks that subject was not on mechanical or non invasive mechanical ventilation.

    Measured: Up to 6 weeks

  7. Time to Polymerase chain reaction (PCR) negativity

    If viremic at starting date of decitabine - time from baseline to 1st recorded negative COVID nucleic acid amplification (NAT) based assay, measured in days.

    Measured: Up to 6 weeks

  8. Percentage of patients with National Early Warning Score 2 of 3 or more

    Determines the degree of illness of a patient and prompts critical care intervention. This composite score includes Respiratory Rate, Temperature, oxygen Saturation, Blood Pressure, Oxygen inspired and cognitive status. This will be measured at baseline and weekly while patient is in hospital.

    Measured: Weekly while patient is in hospital, up to 6 weeks

  9. All-cause mortality at 28 days since randomization

    Total number of death at 28 days since day of randomization

    Measured: Daily upto day 28

  10. Percentage of change of clinical score based on World Health Organization 9-point scale at day 10 from randomization

    Determine clinical score from randomization date to day 10

    Measured: Daily from randomization to day 10

  11. Percentage of change of clinical score based on World Health Organization (WHO 9) COVID progression scale

    Time from randomization to an at least 2-point decrease in clinical score based on WHO 9-point scale

    Measured: Weekly while patient is in hospital, up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start14 Sep 2020
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: IRB00247544 is lapsed. Separate application submitted for reactivation under IRB00521868. Awaiting review \& approval

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04482621
Sponsor's protocol ID
IRB00247544
Other IDs
IRB00521868
Acronym
DART
Status last verified
Aug 2025
First submitted
21 Jul 2020
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PubMed 32109013

  • Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

    PubMed 32217835

  • Anders NM, Liu J, Wanjiku T, Giovinazzo H, Zhou J, Vaghasia A, Nelson WG, Yegnasubramanian S, Rudek MA. Simultaneous quantitative determination of 5-aza-2'-deoxycytidine genomic incorporation and DNA demethylation by liquid chromatography tandem mass spectrometry as exposure-response measures of nucleoside analog DNA methyltransferase inhibitors. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Jun 1;1022:38-45. doi: 10.1016/j.jchromb.2016.03.029. Epub 2016 Mar 21.

    PubMed 27082761

  • Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.

    PubMed 32161940

  • Wang CH, Liu CY, Wan YL, Chou CL, Huang KH, Lin HC, Lin SM, Lin TY, Chung KF, Kuo HP. Persistence of lung inflammation and lung cytokines with high-resolution CT abnormalities during recovery from SARS. Respir Res. 2005 May 11;6(1):42. doi: 10.1186/1465-9921-6-42.

    PubMed 15888207

  • Park WY, Goodman RB, Steinberg KP, Ruzinski JT, Radella F 2nd, Park DR, Pugin J, Skerrett SJ, Hudson LD, Martin TR. Cytokine balance in the lungs of patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1896-903. doi: 10.1164/ajrccm.164.10.2104013.

    PubMed 11734443

  • Luce JM, Montgomery AB, Marks JD, Turner J, Metz CA, Murray JF. Ineffectiveness of high-dose methylprednisolone in preventing parenchymal lung injury and improving mortality in patients with septic shock. Am Rev Respir Dis. 1988 Jul;138(1):62-8. doi: 10.1164/ajrccm/138.1.62.

    PubMed 3202402

  • Bernard GR, Luce JM, Sprung CL, Rinaldo JE, Tate RM, Sibbald WJ, Kariman K, Higgins S, Bradley R, Metz CA, et al. High-dose corticosteroids in patients with the adult respiratory distress syndrome. N Engl J Med. 1987 Dec 17;317(25):1565-70. doi: 10.1056/NEJM198712173172504.

    PubMed 3317054

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PubMed 10793162

  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PubMed 23688302

  • Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.

    PubMed 32320003

  • Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

    PubMed 32167524

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PubMed 32171076

  • Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.

    PubMed 32227758

  • D'Alessio FR, Tsushima K, Aggarwal NR, West EE, Willett MH, Britos MF, Pipeling MR, Brower RG, Tuder RM, McDyer JF, King LS. CD4+CD25+Foxp3+ Tregs resolve experimental lung injury in mice and are present in humans with acute lung injury. J Clin Invest. 2009 Oct;119(10):2898-913. doi: 10.1172/JCI36498. Epub 2009 Sep 21.

    PubMed 19770521

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Decitabine in people with COVID-19, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who are alive and free of respiratory failure at day 28 (time frame: From the day of randomization to day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04482621, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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