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Completed

Duvelisib to Combat COVID-19

ClinicalTrials.gov ID NCT04372602
Sponsor Washington University School of Medicine
Information provided by Washington University School of Medicine (Responsible Party)
Last Update Posted 2023-03-06
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Study Overview

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.
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Official Title
A Pilot Study of Duvelisib to Combat COVID-19
Conditions
COVID-19
Intervention / Treatment
  • Drug: Duvelisib
  • Procedure: Peripheral blood draw
  • Drug: Placebo
  • Drug: Duvelisib
  • Procedure: Peripheral blood draw
  • Drug: Placebo
Other Study ID Numbers
  • 202007009
Study Start (Actual)
2020-10-12
Primary Completion (Actual)
2022-02-06
Study Completion (Actual)
2022-03-02
Enrollment (Actual)
28
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Missouri Locations
Saint Louis, Missouri, United States, 63110

Washington University School of Medicine
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Single Group Assignment
Masking : Triple (ParticipantCare ProviderInvestigator)
Masking Description: Blocks of 10 patients will be used to allocate patients to duvelisib or placebo

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Duvelisib
-Duvelisib 25 mg twice daily for up to 10 days.
Intervention/Treatment Drug: Duvelisib
  • -For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube.

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

Participant Group/Arm Sham Comparator: Placebo
-Placebo 25 mg twice daily for up to 10 days.
Intervention/Treatment Procedure: Peripheral blood draw
    • First 10 patients enrolled
    • Screening, Day 2, Day 4, Day 8, Day 10, Day 15, and Day 29

Drug: Placebo
  • -Provided by Verastem

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Overall Survival as Measured by Number of Participants Alive Through 28 Days Through 28 days
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Length of Hospital Stay Through 28 days
Length of ICU Stay Through 28 days
Duration of Ventilator Use-For those on a ventilator at the time of randomizationThrough 28 days
Duration of Vasopressors Use Through 28 days
Duration on Renal Replacement Therapy Through 28 days
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 testingThrough 28 days
Number of Adverse Events as Measured by CTCAE v. 5.0 Through 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Washington University School of Medicine
Collaborators
  • Verastem, Inc.
Investigators
  • Principal Investigator:John DiPersio, M.D., Ph.D.,Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2020-04-30
First Submitted that Met QC Criteria
2020-04-30
First Posted
2020-05-04
Results Reporting Dates
Results First Submitted
2023-02-01
Results First Posted with QC Comments
2023-03-01
Results First Submitted that Met QC Criteria
2023-03-02
Results First Posted
2023-03-06
Study Record Updates
Last Update Submitted that met QC Criteria
2023-03-02
Last Update Posted
2023-03-06
Last Verified
2023-03

More Information

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Keywords Provided by Washington University School of Medicine
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No