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Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)

Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection

NCT04487886•Emory University

View on ClinicalTrials.gov

Summary

In this study, patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and will be identified and recruited by their treating physician and research team.

Detailed Description

This randomized placebo-controlled phase 2 study will evaluate whether a two-week exposure to duvelisib, a gamma/delta phosphoinositide 3-kinase (PI3K) inhibitor, reduces inflammation in the lungs in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 who do not require mechanical ventilation at study initiation. The primary objective of the study is to determine the efficacy of duvelisib treatment in preventing death or the need for mechanical ventilation among patients with World Health Organization (WHO)-defined severe COVID-19. Key secondary endpoints will be reductions in oxygen requirements of patients and improvements in their performance status, safety and tolerability of duvelisib in the setting of COVID-19, biomarkers of inflammation, and generation of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody responses to SARS-Cov-2 spike protein. The study will determine if a two-week exposure to duvelisib beginning soon after presentation with severe COVID-19 warrants further evaluation in a larger clinical study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Hospitalized in participating facility.
•Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
•Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment. Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.
•Symptoms suggestive of severe systemic illness with COVID-19, such as respiratory rate \> 30 breaths per minute, heart rate \>125 beats per minute, oxygen saturation (O2 sat) in the blood of \<93% on room air at sea level or the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)\< 300
•18 years of age or older
•Patients with hematological parameters at screening consistent with \< grade 2 NCI CTCAE v5.0 toxicity: hemoglobin \>8 g/dL, platelet count \>50,000 K/mcl, an absolute neutrophil count (ANC) \>1,000/mm3, and an absolute lymphocyte count (ALC) \>500/mm3.
•Patients with laboratory measurements of liver function at screening consistent with \< grade 2 NCI CTCAE v5.0 toxicity: alanine aminotransferase (ALT) \< 5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) \< 5 times ULN; and bilirubin \< 3 times ULN.
•The effects of duvelisib on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) must have a negative serum or urine pr5egnancy test prior to starting therapy. WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from enrollment into this study until at least 60 days after the first dose of duvelisib. A woman of childbearing potential (WOCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of duvelisib administration. WOCBP must have a negative pregnancy test within 24 hours of the first dose of duvelisib.
•The patient must be willing to comply with fertility requirements as below:
•* Total abstinence (when this is in line with the usual practice and lifestyle of the patient) will be accepted. Periodic abstinence (i.e., calendar, ovulation, post-ovulation methods) and withdrawals are not acceptable forms
+10 more criteria

Exclusion Criteria

•Patients requiring mechanical ventilation (intubation or Bi-PAP) at the time randomization.
•Patients receiving any investigational drugs other than drugs or therapies to treat COVID-19, with the exception of investigational immune-modulatory drugs as per section 5.4.
•Pregnant women are excluded from this study because duvelisib is agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with duvelisib, breastfeeding should be discontinued before starting study drug and breastfeeding should not be resumed until at least 1 month after last dose of study drug.
•Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
•Known contraindication to duvelisib
•Patients with hepatic cirrhosis as defined by symptomatic liver dysfunction; liver fibrosis by biopsy; ALT \> 5 times ULN, AST\> 5 times ULN, or bilirubin \> 3 times ULN.
•Patients with autoimmune diseases or patients on chronic immunosuppressive medications at the time of hospital admission or screening.

Locations (3)

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Key Dates

Start Date

November 18, 2020

Primary Completion Date

June 10, 2021

Completion Date

June 10, 2021

Last Updated

April 7, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Duvelisib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)

Inclusion Criteria

Exclusion Criteria

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