AzTrials
AzTrials

COVID-19Phase 2NCT04354714

Ruxolitinib to Combat COVID-19

A Phase 2 study testing Ruxolitinib and Peripheral blood draw in people with COVID-19, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease… 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?
Ruxolitinib and Peripheral blood draw
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jun 2020to 31 Dec 2021
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

  • A diagnosis of advanced COVID-19 as defined by both of the following:
  • A positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swab) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab
  • Critical disease manifested by any of the following:
  • Chest imaging (CT or chest X-ray permitted) with ≥ 50% lung involvement
  • Respiratory failure requiring invasive mechanical ventilation or supplementary oxygen with FiO2 ≥ 50%
  • Shock (defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support
Show all 25Show fewer
  • Cardiac dysfunction defined by:
  • New global systolic dysfunction with ejection fraction ≤ 40%
  • Takotsubo cardiomyopathy
  • New onset supraventricular or ventricular arrhythmias
  • Plasma troponin I ≥ 0.10 ng/mL in someone without previously documented troponin elevation beyond that level
  • Elevated plasma NT-proBNP in someone without documented prior elevation
  • If Age < 50, NT-proBNP > 450 pg/ml
  • If Age 50-74, NT-proBNP > 900 pg/ml
  • If Age ≥ 74, NT-proBNP > 1800 pg/ml
  • Receipt of investigational or off-label agents for COVID-19 (prior or ongoing) does not exclude eligibility.
  • Patients who have received autologous or allogeneic stem cell transplant are eligible at the discretion of the investigators.
  • 18 years of age or older at the time of study registration
  • Adequate hematologic function defined as:
  • absolute neutrophil count ≥ 1000/mm3
  • platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening
  • Creatinine clearance ≥ 15 mL/minute or receiving renal replacement therapy
  • Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
  • Male patients (if engaging in reproductive sex with a women of childbearing potential) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Who cannot join

  • Known allergy or intolerance to ruxolitinib or another JAK inhibitor.
  • Known or suspected active viral (including HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
  • Pregnant and/or breastfeeding.
  • Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.

About this study

Official title: A Pilot Study of Ruxolitinib to Combat COVID-19

The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease manifestations.

Conditions
COVID-19
Being tested
Ruxolitinib, Peripheral blood draw
Medical subject headings
COVID-19

What participants receive

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

  • RuxolitinibDrug

    Also called Jakafi

    For patients unable to swallow pills, a ruxolitinib suspension will be administered through a nasogastric/orogastric tube

  • Peripheral blood drawProcedure or surgery

    -Screening, Day 2, Day 4, Day 8, Day 15, and Day 29

Study groups in NCT04354714
Study groupRoleWhat they receive
RuxolitinibExperimental-Ruxolitinib is an oral medication that will be given twice daily (BID). Dosing on Days 1 through 3 will be 5 mg BID; dosing on Days 4 through 10 will be 10 mg BID.
Receives: Drug: Ruxolitinib; Procedure: Peripheral blood draw

What is being measured

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

  1. Overall survival

    Measured: Through 28 days

Secondary outcomes (11)

  1. Length of hospital stay

    Measured: Through completion of follow-up (estimated to be 7 months)

  2. Length of ICU stay

    Measured: Through completion of follow-up (estimated to be 7 months)

  3. Duration of ventilator use

    Measured: Through completion of follow-up (estimated to be 7 months)

  4. Duration of vasopressors use

    Measured: Through completion of follow-up (estimated to be 7 months)

  5. Duration on renal replacement therapy

    Measured: Through completion of follow-up (estimated to be 7 months)

  6. Viral kinetics as measured by virologic failure

    -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing

    Measured: Through completion of follow-up (estimated to be 7 months)

  7. Number of adverse events as measured by CTCAE v. 5.0

    Measured: Through completion of follow-up (estimated to be 7 months)

  8. Proportion of participants with detectable virus

    Measured: Day 5

  9. Proportion of participants with detectable virus

    Measured: Day 10

  10. Proportion of participants with detectable virus

    Measured: Day 15

  11. Proportion of participants with detectable virus

    Measured: Day 29

Timeline

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

  1. First posted21 Apr 2020
  2. Study start30 Jun 2020 (estimated)
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Why it stopped: Could not make FDA required changes

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354714
Sponsor's protocol ID
04-13-20-DiPersio
Status last verified
May 2020
First submitted
16 Apr 2020
Last updated
21 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib and Peripheral blood draw in people with COVID-19, run by Washington University School of Medicine.

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 25 inclusion and 4 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: withdrawn, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Overall survival (time frame: Through 28 days). 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 NCT04354714.

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 21 May 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in