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

NCT04487886 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00000701
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COVID-19

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Number of Participants Requiring Mechanical Ventilation or Dying

  This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.

  Up to Day 29

Secondary Outcomes (28)

• Days to Recovery

  Up to Day 29

• Duration of Hospitalization

  Up to Day 29

• Days on Study Drug

  Up to Day 29

• Total Doses of Study Drug

  Up to Day 29

• Number of Participants Dying

  Up to Day 29

Other Outcomes (1)

• Vasoactive Intestinal Peptide (VIP)

  Week 1, Week 2

Study Arms (2)

Duvelisib

EXPERIMENTAL

Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days.

Drug: Duvelisib

Placebo

PLACEBO COMPARATOR

Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive a placebo to match duvelisib for 14 days.

Drug: Placebo

Interventions

Duvelisib DRUG

Duvelisib will be taken orally at an initial dose of 25 milligrams (mg) twice per day for 14 days. The dose will be de-escalated to 15 mg, twice per day, under certain clinical circumstances.

Also known as: Copiktra

Duvelisib

Placebo DRUG

A placebo to match duvelisib will be taken orally twice per day for 14 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• If a female participant is of reproductive potential, the participant (and her partner) must agree to use of one of the following combinations of birth control during the study and for 2 months after the last dose of study drug (or tubal ligation as a single method):
• Use of a double-barrier method of contraception: condoms (male or female) and a diaphragm or cervical cap with spermicide;
• Use of an IUD and a barrier method: condoms (male or female, with or without spermicide) or a diaphragm or cervical cap with spermicide;
• Tubal ligation.
• Women who are post-menopausal, defined as age greater than 45 and no menses for at least 24 consecutive months, or who have had a hysterectomy, are considered not of reproductive potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Verastem, Inc.: collaborator

Study Sites (3)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Edmund Waller, MD, PhD
• Organization: Emory University

ewaller@emory.edu

404-727-4995

Study Officials

• Edmund Waller, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 27, 2020
• Study Start: November 18, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available for sharing at the conclusion of the study and will be available for one year.
• Access Criteria: Data will be available for sharing with academic or pharmaceutical investigators for analyses including comparison of DAMPEN-CI results with those from other drug trials in similar patient cohorts. Researchers wishing to use data should email the investigators of DAMPEN-Cl. A summary of the research plan will be required prior to release of the DAMPEN-CI data.

Locations

US (3)