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Duvelisib to Combat COVID-19

NCT04372602 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-03-06

Study results available
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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.

Conditions

Interventions

DRUG

Duvelisib

-For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube.

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

Sponsors & Collaborators

  • Verastem, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • John DiPersio, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2022-02-06
Completion
2022-03-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372602 on ClinicalTrials.gov