COVID-19Phase 2NCT04372602
Duvelisib to Combat COVID-19
A Phase 2 study testing Duvelisib and Peripheral blood draw in people with COVID-19, run by Washington University School of Medicine at 1 site in United States.
Trial 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. 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?
- Duvelisib and Peripheral blood draw
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 2 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pilot Study of Duvelisib to Combat COVID-19
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.
- Conditions
- COVID-19
- Being tested
- Duvelisib, Peripheral blood draw, Placebo
- 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.
DuvelisibDrug
Also called Copiktra
-For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube.
Peripheral blood drawProcedure or surgery
- First 10 patients enrolled
- Screening, Day 2, Day 4, Day 8, Day 10, Day 15, and Day 29
PlaceboDrug
-Provided by Verastem
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib | Experimental | -Duvelisib 25 mg twice daily for up to 10 days. Receives: Drug: Duvelisib; Procedure: Peripheral blood draw |
| Placebo | Sham comparator | -Placebo 25 mg twice daily for up to 10 days. Receives: Procedure: Peripheral blood draw; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival as Measured by Number of Participants Alive Through 28 Days
Measured: Through 28 days
Secondary outcomes (7)
Length of Hospital Stay
Measured: Through 28 days
Length of ICU Stay
Measured: Through 28 days
Duration of Ventilator Use
-For those on a ventilator at the time of randomization
Measured: Through 28 days
Duration of Vasopressors Use
Measured: Through 28 days
Duration on Renal Replacement Therapy
Measured: 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 testing
Measured: Through 28 days
Number of Adverse Events as Measured by CTCAE v. 5.0
Measured: Through 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start12 Oct 2020
- Primary completion6 Feb 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Verastem, Inc.
- Responsible party
- Sponsor
- Investigators
- John DiPersio, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372602
- Sponsor's protocol ID
- 202007009
- Status last verified
- Mar 2023
- First submitted
- 30 Apr 2020
- Last updated
- 6 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldsmith SR, Covut F, Fiala M, Xiang Z, Iqbal Z, Moore N, Bradtke E, Christen B, Rettig MP, Christ S, Gehrs L, Street E, Wallace N, Ritchey J, Gao F, Pachter J, Parikh B, Dubberke ER, DiPersio JF. Duvelisib for Critically Ill Patients With Coronavirus Disease 2019: An Investigator-Initiated, Randomized, Placebo-Controlled, Double-Blind Pilot Trial. Open Forum Infect Dis. 2023 Oct 27;10(11):ofad518. doi: 10.1093/ofid/ofad518. eCollection 2023 Nov.
PubMed 37953814
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Duvelisib to Combat COVID-19
- ClinicalTrials.gov ID
- NCT04372602
- Acronym / sponsor ID
- 202007009
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Verastem, Inc.
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Posted 6 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duvelisib | Experimental | Drug: Duvelisib, Procedure: Peripheral blood draw-Duvelisib 25 mg twice daily for up to 10 days. |
| Placebo | Sham comparator | Procedure: Peripheral blood draw, Drug: Placebo-Placebo 25 mg twice daily for up to 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A diagnosis of advanced COVID-19 as defined both of the following:
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibAlso: Copiktra-For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube. | Drug | Duvelisib |
| Peripheral blood draw* First 10 patients enrolled * Screening, Day 2, Day 4, Day 8, Day 10, Day 15, and Day 29 | Procedure or surgery | Duvelisib, Placebo |
| Placebo-Provided by Verastem | Drug | Placebo |
Primary outcome
Overall Survival as Measured by Number of Participants Alive Through 28 Days
Time frame: Through 28 days
7 secondary outcomes
Length of Hospital Stay
Time frame: Through 28 days
Length of ICU Stay
Time frame: Through 28 days
Duration of Ventilator Use
Time frame: Through 28 days
Duration of Vasopressors Use
Time frame: Through 28 days
Duration on Renal Replacement Therapy
Time frame: Through 28 days
Viral Kinetics as Measured by Virologic Failure
Time frame: Through 28 days
Number of Adverse Events as Measured by CTCAE v. 5.0
Time frame: Through 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37953814Goldsmith SR, Covut F, Fiala M, Xiang Z, Iqbal Z, Moore N, Bradtke E, Christen B, Rettig MP, Christ S, Gehrs L, Street E, Wallace N, Ritchey J, Gao F, Pachter J, Parikh B, Dubberke ER, DiPersio JF. Duvelisib for Critically Ill Patients With Coronavirus Disease 2019: An Investigator-Initiated, Randomized, Placebo-Controlled, Double-Blind Pilot Trial. Open Forum Infect Dis. 2023 Oct 27;10(11):ofad518. doi: 10.1093/ofid/ofad518. eCollection 2023 Nov.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John DiPersio, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvelisib and Peripheral blood draw in people with COVID-19, run by Washington University School of Medicine 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 17 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: finished, as of the sponsor's last update on 6 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 as Measured by Number of Participants Alive Through 28 Days (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 NCT04372602, which also lists 1 linked publication.
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 6 Mar 2023.