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Duvelisib to Combat COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372602
Recruitment Status : Not yet recruiting
First Posted : May 4, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Verastem, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Duvelisib Procedure: Peripheral blood draw Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Blocks of 10 patients will be used to allocate patients to duvelisib or placebo
Primary Purpose: Treatment
Official Title: A Pilot Study of Duvelisib to Combat COVID-19
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
Experimental: Duvelisib
-Duvelisib 25 mg twice daily for up to 10 days. Patients who have significant clinical improvement prior to day 10 and are going to be discharged from the hospital may discontinue the treatment early with investigator permission.
Drug: Duvelisib
-For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube.
Other Name: Copiktra

Procedure: Peripheral blood draw
  • First 10 patients enrolled
  • Screening, Day 2, Day 4, Day 8, Day 15, and Day 29

Sham Comparator: Placebo
-Placebo 25 mg twice daily for up to 10 days. Patients who have significant clinical improvement prior to day 10 and are going to be discharged from the hospital may discontinue the treatment early with investigator permission.
Procedure: Peripheral blood draw
  • First 10 patients enrolled
  • Screening, Day 2, Day 4, Day 8, Day 15, and Day 29

Drug: Placebo
-Provided by Verastem




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Through 28 days ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  2. Length of ICU stay [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  3. Duration of ventilator use [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
    -For those on a ventilator at the time of randomization

  4. Duration of vasopressors use [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  5. Duration on renal replacement therapy [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  6. Viral kinetics as measured by virologic failure [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
    -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

  7. Number of adverse events as measured by CTCAE v. 5.0 [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of advanced COVID-19 as defined both of the following:

    • as a positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (e.g. nasopharyngeal, nasal, oropharyngeal swab, or saliva) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab with an FDA approved assay.
    • Critical disease manifested by any of the following:

      • Chest imaging with ≥ 50% lung involvement
      • Respiratory failure requiring invasive mechanical ventilation, non-invasive mechanical ventilation (eg. BiPAPA, OptiFlow), supplementary oxygen with FiO2 ≥ 6 LPM or extracorporeal membrane oxygenation (ECMO)
      • Shock - defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support
      • Cardiac dysfunction defined by:

        • New global systolic dysfunction with ejection fraction ≤ 40%
        • Takotsubo cardiomyopathy
  • Patients who have received prior investigational or off-label agents for COVID-19 does not exclude eligibility.
  • At least 18 years of age at the time of study registration
  • Adequate hematologic function defined as absolute neutrophil count ≥1000/mm3 and 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
  • Aminotransferase (AST/ALT) levels <3x the upper limit of normal
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)
  • 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 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.

Exclusion Criteria:

  • Known allergy or intolerance to duvelisib or another PI3K inhibitor.
  • Known or suspected active viral (including CMV, HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. CMV viral load will be assessed at screening and those with viremia will be excluded. Other 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372602


Contacts
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Contact: John DiPersio, M.D., Ph.D. 314-454-8491 jdipersi@wustl.edu
Contact: Erik Dubberke, M.D., MSPH 314-454-8293 edubberk@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: John DiPersio, M.D., Ph.D.    314-454-8491    jdipersi@wustl.edu   
Contact: Erik Dubberke, M.D., MSPH    314-454-8293    edubberk@wustl.edu   
Principal Investigator: John DiPersio, M.D., Ph.D.         
Sub-Investigator: Erik Dubberke, M.D., MSPH         
Sub-Investigator: Mark Fiala, MSW         
Sponsors and Collaborators
Washington University School of Medicine
Verastem, Inc.
Investigators
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Principal Investigator: John DiPersio, M.D., Ph.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04372602    
Other Study ID Numbers: 202007009
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Washington University School of Medicine:
COVID-19