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| Name | Class |
|---|---|
| Verastem, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvelisib | Experimental | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Recovery | Time to recovery is measured in days, from the day of randomization to the day of recovery, with recovery defined as a score of equal to or greater than 5 from the eight categories from the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale. The scale is as follows: 1 = Death, 2 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4 = Hospitalized, requiring supplemental oxygen, 5 = Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise), 6 = Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;=, 7 = Not hospitalized, limitation on activities and/or requiring home oxygen, and 8 = Not hospitalized, no limitations on activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Vasoactive Intestinal Peptide (VIP) | VIP is a peptide hormone with immunosuppressive properties. Mean levels VIP will be compared between study arms. | Week 1, Week 2 |
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
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):
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.
Males must agree to using contraception during the study and for 2 months after the last dose of study drug or have undergone a male sterilization procedure (at least 6 months prior to screening.
Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception, or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of contraception that comparable efficacy (failure rate <1%). In case of oral contraception, the woman should be stable on the same pill for a minimum of 3 months prior to enrollment on the study.
Patients must agree not to donate blood, sperm/ova or any other organs while taking protocol therapy and for at least 2 weeks after stopping treatment.
Willingness and ability of the patient to comply with scheduled visits, drug administration plan, protocol specified laboratory tests, other study procedures and study restrictions
Evidence of personally signed informed consent indicating that the subject is aware of the life-threatening nature of the disease and has been informed on the procedures to be followed, the experimental nature of the therapy, alternative, potential risks and discomforts, potential benefits and other pertinent aspects of study participation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmund Waller, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital Midtown |
The researchers plan to share individual participant data including participant status ordinal score at baseline and end of treatment, study drug allocation, duration of treatment, and survival status at Day 60.
Data will be made available for sharing at the conclusion of the study and will be available for one year.
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.
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Participants were recruited at Emory University Hospital in Atlanta, Georgia, USA. Participant enrollment began November 18, 2020 and all follow-up assessments were completed by June 10, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duvelisib | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. 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. |
| FG001 | Placebo | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive a placebo to match duvelisib for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duvelisib | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. |
| BG001 | Placebo | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive a placebo to match duvelisib for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to Day 29 |
|
Information on adverse events was collected beginning at the time study treatment began until 14 days following cessation of duvelisib or placebo (up to Day 29). Survival status was assessed up to Day 60.
Adverse events that began or worsened after informed consent to participate was given were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duvelisib | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transfer to ICU and/or initiation of mechanical ventilation | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High alanine transaminase (ALT) - grade 2 | Hepatobiliary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edmund Waller, MD, PhD | Emory University | 404-727-4995 | ewaller@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2021 | Dec 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C586691 | duvelisib |
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|
| Placebo | Drug | A placebo to match duvelisib will be taken orally twice per day for 14 days. |
|
| Up to Day 29 |
| Duration of Hospitalization | The number of days spent hospitalized is presented for both study arms. | Up to Day 29 |
| Days on Study Drug | The number of days that participants took any doses of the study drug that they were randomized to receive is presented for both study arms. | Up to Day 29 |
| Total Doses of Study Drug | The study medication was taken twice per day for 14 days. The number of doses of study medication that was taken is presented for both study arms. | Up to Day 29 |
| Number of Participants Dying | The incidence of death within 29 days of randomization is compared between study arms. | Up to Day 29 |
| Number of Participants Transferred to ICU | The number of participants who were transferred to the intensive care unit (ICU) within 29 days of randomization. | Up to Day 29 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score | The ECOG Performance Status instrument includes a single item assessing overall physical status. Health status is rated on a scale of 0 to 5 where 0 = fully active, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 = ambulatory and capable of all selfcare but unable to carry out any work activities, 3 = capable of only limited selfcare, completely disabled, and 5 = dead. Median ECOG performance is compared between study arms. | Between Day 14 and 28, Between Day 29 and 60 |
| Number of Grade III-V Adverse Events | The incidence of grade III-V adverse events or serious adverse events (SAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5, is compared between study arms. Grade 3 lab values that required no special treatment are excluded from this outcome measure. | Up to Day 29 |
| Number of Secondary Bacterial or Viral Infections | The incidence of documented secondary bacterial or viral infections among participants is compared between study arms. | Up to Day 29 |
| T Helper 1 (Th1) T Cell Frequency | The mean frequency of Th1 T cells in peripheral blood mononuclear cells (PBMCs) is compared between study arms. | Week 1, Week 2 |
| Th17 T Cell Frequency | The mean frequency of Th17 T cells in PBMCs is compared between study arms. | Week 1, Week 2 |
| Interleukin-2 (IL-2) Levels | Mean levels of the inflammatory serum biomarker IL-2 is compared between study arms. | Week 1, Week 2 |
| Interleukin-2 Receptor (IL-2R) Levels | Mean levels of the inflammatory serum biomarker IL-2R is compared between study arms. | Week 1, Week 2 |
| Interleukin-6 (IL-6) Levels | Mean levels of the inflammatory serum biomarker IL-6 is compared between study arms. | Week 1, Week 2 |
| Interleukin-7 (IL-7) Levels | Mean levels of the inflammatory serum biomarker IL-7 is compared between study arms. | Week 1, Week 2 |
| Interleukin-8 (IL-8) Levels | Mean levels of the inflammatory serum biomarker IL-8 is compared between study arms. | Week 1, Week 2 |
| Interleukin-10 (IL-10) Levels | Mean levels of the inflammatory serum biomarker IL-10 is compared between study arms. | Week 1, Week 2 |
| Interferon Gamma-induced Protein 10 (IP-10) Levels | Mean levels of the inflammatory serum biomarker IP-10is compared between study arms. | Week 1, Week 2 |
| Macrophage Inflammatory Protein 1alpha (MIP-1a) Levels | Mean levels of the inflammatory serum biomarker MIP-1a is compared between study arms. | Week 1, Week 2 |
| Monocyte Chemoattractant Protein-1 (MCP-1) Levels | Mean levels of the inflammatory serum biomarker MCP-1 are compared between study arms. | Week 1, Week 2 |
| Granulocyte Colony-stimulating Factor (G-CSF) Levels | Mean levels of the inflammatory serum biomarker G-CSF are compared between study arms. | Week 1, Week 2 |
| Tumor Necrosis Factor (TNF)-Alpha Levels | Mean levels of the inflammatory serum biomarker TNF-alpha are compared between study arms. | Week 1, Week 2 |
| Gene Expression Profile of Regulatory T Cells (Tregs) | Single-cell ribonucleic acid (RNA) sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of the Tregs will be compared between study arms. | Week 1, Week 2 |
| Gene Expression Profile of Cluster of Differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)+ | Single-cell RNA sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of CD8+IFNg+GM-CSF+ will be compared between study arms. | Week 1, Week 2 |
| Gene Expression Profile of CD8+ T Cell Immunoglobulin and Mucin Domain-containing Protein 3 (Tim3)+ Programmed Cell Death Protein 1 (PD-1)+ | Single-cell RNA sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of CD8+Tim3+PD-1+ will be compared between study arms. | Week 1, Week 2 |
| Gene Expression Profile of Cluster of Differentiation 14 (CD14)+ Cluster of Differentiation (CD16)+ Monocytes | Single-cell RNA sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of CD14+CD16+ monocytes will be compared between study arms. | Week 1, Week 2 |
| Immunoglobin G (IgG) Antibodies | Median titers of IgG antibodies to SARS-CoV-2 at 4 weeks will be assessed for both study arms. | Week 4 |
| Number of Participants Surviving | Overall survival is defined as days from randomization to death and censored at last follow up. | Up to Day 60 |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Days to Recovery | Time to recovery is measured in days, from the day of randomization to the day of recovery, with recovery defined as a score of equal to or greater than 5 from the eight categories from the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale. The scale is as follows: 1 = Death, 2 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4 = Hospitalized, requiring supplemental oxygen, 5 = Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise), 6 = Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;=, 7 = Not hospitalized, limitation on activities and/or requiring home oxygen, and 8 = Not hospitalized, no limitations on activities. | This analysis includes participants who recovered; one participant in the placebo study arm passed away and is not included in this analysis. | Posted | Mean | Standard Deviation | days | Up to Day 29 |
|
|
|
| Secondary | Duration of Hospitalization | The number of days spent hospitalized is presented for both study arms. | Posted | Mean | Standard Deviation | days | Up to Day 29 |
|
|
|
| Secondary | Days on Study Drug | The number of days that participants took any doses of the study drug that they were randomized to receive is presented for both study arms. | Posted | Mean | Standard Deviation | days | Up to Day 29 |
|
|
|
| Secondary | Total Doses of Study Drug | The study medication was taken twice per day for 14 days. The number of doses of study medication that was taken is presented for both study arms. | Posted | Mean | Standard Deviation | drug doses | Up to Day 29 |
|
|
|
| Secondary | Number of Participants Dying | The incidence of death within 29 days of randomization is compared between study arms. | Posted | Count of Participants | Participants | Up to Day 29 |
|
|
|
| Secondary | Number of Participants Transferred to ICU | The number of participants who were transferred to the intensive care unit (ICU) within 29 days of randomization. | Posted | Count of Participants | Participants | Up to Day 29 |
|
|
|
| Secondary | Eastern Cooperative Oncology Group (ECOG) Performance Status Score | The ECOG Performance Status instrument includes a single item assessing overall physical status. Health status is rated on a scale of 0 to 5 where 0 = fully active, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 = ambulatory and capable of all selfcare but unable to carry out any work activities, 3 = capable of only limited selfcare, completely disabled, and 5 = dead. Median ECOG performance is compared between study arms. | This analysis includes participants who were able to be contacted for this assessment, or those with relevant information in the medical chart. | Posted | Median | Standard Deviation | score on a scale | Between Day 14 and 28, Between Day 29 and 60 |
|
|
|
| Secondary | Number of Grade III-V Adverse Events | The incidence of grade III-V adverse events or serious adverse events (SAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5, is compared between study arms. Grade 3 lab values that required no special treatment are excluded from this outcome measure. | Posted | Number | grade III-V adverse events | Up to Day 29 |
|
|
|
| Secondary | Number of Secondary Bacterial or Viral Infections | The incidence of documented secondary bacterial or viral infections among participants is compared between study arms. | Posted | Number | infections | Up to Day 29 |
|
|
|
| Secondary | T Helper 1 (Th1) T Cell Frequency | The mean frequency of Th1 T cells in peripheral blood mononuclear cells (PBMCs) is compared between study arms. | Posted | Mean | Standard Deviation | percentage of CD4 T cells | Week 1, Week 2 |
|
|
|
| Secondary | Th17 T Cell Frequency | The mean frequency of Th17 T cells in PBMCs is compared between study arms. | Posted | Mean | Standard Deviation | percentage of CD4 T cells | Week 1, Week 2 |
|
|
|
| Secondary | Interleukin-2 (IL-2) Levels | Mean levels of the inflammatory serum biomarker IL-2 is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Interleukin-2 Receptor (IL-2R) Levels | Mean levels of the inflammatory serum biomarker IL-2R is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Interleukin-6 (IL-6) Levels | Mean levels of the inflammatory serum biomarker IL-6 is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Interleukin-7 (IL-7) Levels | Mean levels of the inflammatory serum biomarker IL-7 is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Interleukin-8 (IL-8) Levels | Mean levels of the inflammatory serum biomarker IL-8 is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Interleukin-10 (IL-10) Levels | Mean levels of the inflammatory serum biomarker IL-10 is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Interferon Gamma-induced Protein 10 (IP-10) Levels | Mean levels of the inflammatory serum biomarker IP-10is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Macrophage Inflammatory Protein 1alpha (MIP-1a) Levels | Mean levels of the inflammatory serum biomarker MIP-1a is compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Monocyte Chemoattractant Protein-1 (MCP-1) Levels | Mean levels of the inflammatory serum biomarker MCP-1 are compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Granulocyte Colony-stimulating Factor (G-CSF) Levels | Mean levels of the inflammatory serum biomarker G-CSF are compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Tumor Necrosis Factor (TNF)-Alpha Levels | Mean levels of the inflammatory serum biomarker TNF-alpha are compared between study arms. | This analysis includes participants who had blood samples obtained at both study time points. Two participants in the placebo arm had samples missing for one of the time points. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 2 |
|
|
|
| Secondary | Gene Expression Profile of Regulatory T Cells (Tregs) | Single-cell ribonucleic acid (RNA) sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of the Tregs will be compared between study arms. | Due to funding limitations single-cell RNA sequencing was not performed. As the focus of this study was to determine the immune profile consisting of immune cell composition and serum cytokine/chemokine other laboratory experiments provided sufficient data for this purpose. | Posted | Week 1, Week 2 |
|
|
| Secondary | Gene Expression Profile of Cluster of Differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)+ | Single-cell RNA sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of CD8+IFNg+GM-CSF+ will be compared between study arms. | Due to funding limitations single-cell RNA sequencing was not performed. As the focus of this study was to determine the immune profile consisting of immune cell composition and serum cytokine/chemokine other laboratory experiments provided sufficient data for this purpose. | Posted | Week 1, Week 2 |
|
|
| Secondary | Gene Expression Profile of CD8+ T Cell Immunoglobulin and Mucin Domain-containing Protein 3 (Tim3)+ Programmed Cell Death Protein 1 (PD-1)+ | Single-cell RNA sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of CD8+Tim3+PD-1+ will be compared between study arms. | Due to funding limitations single-cell RNA sequencing was not performed. As the focus of this study was to determine the immune profile consisting of immune cell composition and serum cytokine/chemokine other laboratory experiments provided sufficient data for this purpose. | Posted | Week 1, Week 2 |
|
|
| Secondary | Gene Expression Profile of Cluster of Differentiation 14 (CD14)+ Cluster of Differentiation (CD16)+ Monocytes | Single-cell RNA sequencing is a powerful gene expression profiling tool to acquire transcriptional level information of each gene. Mean levels of CD14+CD16+ monocytes will be compared between study arms. | Due to funding limitations single-cell RNA sequencing was not performed. As the focus of this study was to determine the immune profile consisting of immune cell composition and serum cytokine/chemokine other laboratory experiments provided sufficient data for this purpose. | Posted | Week 1, Week 2 |
|
|
| Secondary | Immunoglobin G (IgG) Antibodies | Median titers of IgG antibodies to SARS-CoV-2 at 4 weeks will be assessed for both study arms. | Due to budget limitations other laboratory experiments were prioritized and Immunoglobulin G (IgG) antibodies were not measured. | Posted | Week 4 |
|
|
| Secondary | Number of Participants Surviving | Overall survival is defined as days from randomization to death and censored at last follow up. | Posted | Count of Participants | Participants | Up to Day 60 |
|
|
|
| Other Pre-specified | Vasoactive Intestinal Peptide (VIP) | VIP is a peptide hormone with immunosuppressive properties. Mean levels VIP will be compared between study arms. | Due to budget limitations other laboratory experiments were prioritized and VIP (an exploratory outcome) was not analyzed. | Posted | Week 1, Week 2 |
|
|
| 0 |
| 25 |
| 6 |
| 25 |
| 5 |
| 25 |
| EG001 | Placebo | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive a placebo to match duvelisib for 14 days. | 1 | 22 | 2 | 22 | 5 | 22 |
| Post-discharge hospitalization | General disorders | Non-systematic Assessment |
|
| Leukopenia - grade 2 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphopenia - grade 2 or 3 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Single assessment between Day 29 and 60 |
|
|