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NCT04372602

Duvelisib to Combat COVID-19

Completed Phase 2 Results posted Last updated 6 March 2023
What this trial tests

Phase 2 trial testing Duvelisib in COVID-19 in 28 participants. Completed in 2 March 2022.

Timeline
12 October 2020
Primary endpoint
6 February 2022
2 March 2022

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingtriple
Primary purposetreatment
Enrollment28
Start date12 October 2020
Primary completion6 February 2022
Estimated completion2 March 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival as Measured by Number of Participants Alive Through 28 Days Primary · Through 28 days
GroupValue95% CI
Duvelisib10
Placebo8
Length of Hospital Stay Secondary · Through 28 days
GroupValue95% CI
Duvelisib197 – 28
Placebo247 – 28
Length of ICU Stay Secondary · Through 28 days
GroupValue95% CI
Duvelisib195 – 28
Placebo20.507 – 28
Duration of Ventilator Use Secondary · Through 28 days

-For those on a ventilator at the time of randomization

GroupValue95% CI
Duvelisib162 – 28
Placebo2011 – 28
Duration of Vasopressors Use Secondary · Through 28 days
GroupValue95% CI
Duvelisib97 – 28
Placebo199 – 28
Duration on Renal Replacement Therapy Secondary · Through 28 days
GroupValue95% CI
Duvelisib2828 – 28
Placebo1913 – 28
Viral Kinetics as Measured by Virologic Failure Secondary · Through 28 days

-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

GroupValue95% CI
Duvelisib3
Placebo5
Number of Adverse Events as Measured by CTCAE v. 5.0 Secondary · Through 29 days
Grade 1/2 anemia
GroupValue95% CI
Duvelisib1
Placebo1
Grade 3/4/5 anemia
GroupValue95% CI
Duvelisib1
Placebo2
Grade 1/2 leukocytosis
GroupValue95% CI
Duvelisib0
Placebo1
Grade 1/2 atrial fibrillation
GroupValue95% CI
Duvelisib1
Placebo2
Grade 3/4/5 cardiac arrest
GroupValue95% CI
Duvelisib1
Placebo0
Grade 1/2 pericarditis
GroupValue95% CI
Duvelisib1
Placebo0
Grade 1/2 sinus bradycardia
GroupValue95% CI
Duvelisib1
Placebo1
Grade 1/2 sinus tachycardia
GroupValue95% CI
Duvelisib2
Placebo2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Duvelisib
Serious: 6/15 (40%)
Deaths: 6/15
Placebo
Serious: 8/13 (62%)
Deaths: 8/13

Serious adverse events (8 terms)

ReactionSystemDuvelisibPlacebo
Respiratory failureRespiratory, thoracic and mediastinal disorders——
Lung infectionInfections and infestations——
Cardiac arrestCardiac disorders——
Upper gastrointestinal hemorrhageGastrointestinal disorders——
CholecystitisHepatobiliary disorders——
SepsisInfections and infestations——
Intracranial hemorrhageNervous system disorders——
StrokeNervous system disorders——
Other adverse events (66 terms — click to expand)

ReactionSystemDuvelisibPlacebo
HypotensionVascular disorders——
AnemiaBlood and lymphatic system disorders——
VomitingGastrointestinal disorders——
Lung infectionInfections and infestations——
HyperkalemiaMetabolism and nutrition disorders——
HypernatremiaMetabolism and nutrition disorders——
HematuriaRenal and urinary disorders——
EpistaxisRespiratory, thoracic and mediastinal disorders——
Atrial fibrillationCardiac disorders——
Sinus tachycardiaCardiac disorders——
IleusGastrointestinal disorders——
FeverGeneral disorders——
TracheitisInfections and infestations——
Urinary tract infectionInfections and infestations——
Alanine aminotransferase increasedInvestigations——
Platelet count decreasedInvestigations——
AcidosisMetabolism and nutrition disorders——
HyponatremiaMetabolism and nutrition disorders——
Acute kidney injuryRenal and urinary disorders——
Thromboembolic eventVascular disorders——
LeukocytosisBlood and lymphatic system disorders——
PericarditisCardiac disorders——
Sinus bradycardiaCardiac disorders——
Ventricular arrhythmiaCardiac disorders——
Middle ear inflammationEar and labyrinth disorders——
ConjunctivitisEye disorders——
Corneal ulcerEye disorders——
ColitisGastrointestinal disorders——
ConstipationGastrointestinal disorders——
DiarrheaGastrointestinal disorders——
GastroparesisGastrointestinal disorders——
Lower gastrointestinal hemorrhageGastrointestinal disorders——
MelenaGastrointestinal disorders——
Mucositis oralGastrointestinal disorders——
Oral hemorrhageGastrointestinal disorders——
PancreatitisGastrointestinal disorders——
Rectal ulcerGastrointestinal disorders——
HypothermiaGeneral disorders——
BacteremiaInfections and infestations——
Conjunctivitis infectiveInfections and infestations——

Most-reported serious reactions: Respiratory failure, Lung infection, Cardiac arrest, Upper gastrointestinal hemorrhage, Cholecystitis, Sepsis, Intracranial hemorrhage, Stroke.

Data from ClinicalTrials.gov NCT04372602 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
    Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
  2. The PI3K/Akt/mTOR pathway: A potential pharmacological target in COVID-19.
    Basile MS, Cavalli E, McCubrey J, Hernández-Bello J, et al · · 2022 · cited 81× · PMID 34763066 · DOI 10.1016/j.drudis.2021.11.002
  3. COVID-19 and Cancer Comorbidity: Therapeutic Opportunities and Challenges.
    Pathania AS, Prathipati P, Abdul BA, Chava S, et al · · 2021 · cited 71× · PMID 33391502 · DOI 10.7150/thno.51471
  4. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  5. Repurposing anticancer drugs for the management of COVID-19.
    El Bairi K, Trapani D, Petrillo A, Le Page C, et al · · 2020 · cited 59× · PMID 33125946 · DOI 10.1016/j.ejca.2020.09.014
  6. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
    Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
  7. Outbreak of COVID-19: An emerging global pandemic threat.
    Peng M. · · 2020 · cited 42× · PMID 32768974 · DOI 10.1016/j.biopha.2020.110499
  8. PI3K Signaling in Mechanisms and Treatments of Pulmonary Fibrosis Following Sepsis and Acute Lung Injury.
    Margaria JP, Moretta L, Alves-Filho JC, Hirsch E. · · 2022 · cited 41× · PMID 35453505 · DOI 10.3390/biomedicines10040756

Verify or expand the search:

Other trials of Duvelisib

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

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