Phase 2
N=47
Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04487886 ↗Enrolled (actual)
47
Serious AEs
17.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants Requiring Mechanical Ventilation or Dying — 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Duvelisib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Requiring Mechanical Ventilation or Dying |
3; 3 | — |
| SECONDARY Days to Recovery |
6.00; 5.29 | — |
| SECONDARY Duration of Hospitalization |
6.72; 6.95 | — |
| SECONDARY Days on Study Drug |
4.6; 5.18 | — |
| SECONDARY Total Doses of Study Drug |
7.76; 8.91 | — |
| SECONDARY Number of Participants Dying |
0; 1 | — |
| SECONDARY Number of Participants Transferred to ICU |
3; 3 | — |
| SECONDARY Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
2; 1.5; 1; 1 | — |
| SECONDARY Number of Grade III-V Adverse Events |
6; 3 | — |
| SECONDARY Number of Secondary Bacterial or Viral Infections |
0; 1; 0; 0 | — |
| SECONDARY T Helper 1 (Th1) T Cell Frequency |
19.52; 20.14; 19.98; 18.27 | — |
| SECONDARY Th17 T Cell Frequency |
2.24; 3.43; 3.16; 4.25 | — |
| SECONDARY Interleukin-2 (IL-2) Levels |
0.08723; 62.8596; 17.3632; 0.3158 | — |
| SECONDARY Interleukin-2 Receptor (IL-2R) Levels |
1172.80; 3569.93; 912.47; 2005.94 | — |
| SECONDARY Interleukin-6 (IL-6) Levels |
7.9388; 149.73; 14.2294; 52.2227 | — |
| SECONDARY Interleukin-7 (IL-7) Levels |
4.6018; 198.80; 3.2255; 48.5118 | — |
| SECONDARY Interleukin-8 (IL-8) Levels |
3.1109; 104.03; 3.4120; 26.6383 | — |
| SECONDARY Interleukin-10 (IL-10) Levels |
389.02; 808.09; 658.17; 250.00 | — |
| SECONDARY Interferon Gamma-induced Protein 10 (IP-10) Levels |
3136.50; 4781.42; 2956.68; 3809.83 | — |
| SECONDARY Macrophage Inflammatory Protein 1alpha (MIP-1a) Levels |
29.0477; 123.60; 43.0115; 57.5810 | — |
| SECONDARY Monocyte Chemoattractant Protein-1 (MCP-1) Levels |
122.63; 124.80; 255.30; 187.12 | — |
| SECONDARY Granulocyte Colony-stimulating Factor (G-CSF) Levels |
8.1585; 157.86; 8.6447; 39.7275 | — |
| SECONDARY Tumor Necrosis Factor (TNF)-Alpha Levels |
1.3291; 81.0170; 2.6108; 17.0332 | — |
| SECONDARY Gene Expression Profile of Regulatory T Cells (Tregs) |
— | — |
| SECONDARY Gene Expression Profile of Cluster of Differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)+ |
— | — |
| SECONDARY Gene Expression Profile of CD8+ T Cell Immunoglobulin and Mucin Domain-containing Protein 3 (Tim3)+ Programmed Cell Death Protein 1 (PD-1)+ |
— | — |
| SECONDARY Gene Expression Profile of Cluster of Differentiation 14 (CD14)+ Cluster of Differentiation (CD16)+ Monocytes |
— | — |
| SECONDARY Immunoglobin G (IgG) Antibodies |
— | — |
| SECONDARY Number of Participants Surviving |
25; 21 | — |
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.
Eligibility Criteria
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 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 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.
Data sourced from ClinicalTrials.gov (NCT04487886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.