COVID-19Phase 2DAMPEN-CINCT04487886
Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)
A Phase 2 study testing Duvelisib in people with COVID-19, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Duvelisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Nov 2020to 10 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Duvelisib, Placebo
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called Copiktra
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.
PlaceboDrug
A placebo to match duvelisib will be taken orally twice per day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib | Experimental | Participants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 29
Secondary outcomes (28)
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.
Measured: Up to Day 29
Duration of Hospitalization
The number of days spent hospitalized is presented for both study arms.
Measured: 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.
Measured: 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.
Measured: Up to Day 29
Number of Participants Dying
The incidence of death within 29 days of randomization is compared between study arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 2
Th17 T Cell Frequency
The mean frequency of Th17 T cells in PBMCs is compared between study arms.
Measured: Week 1, Week 2
Interleukin-2 (IL-2) Levels
Mean levels of the inflammatory serum biomarker IL-2 is compared between study arms.
Measured: Week 1, Week 2
Interleukin-2 Receptor (IL-2R) Levels
Mean levels of the inflammatory serum biomarker IL-2R is compared between study arms.
Measured: Week 1, Week 2
Interleukin-6 (IL-6) Levels
Mean levels of the inflammatory serum biomarker IL-6 is compared between study arms.
Measured: Week 1, Week 2
Interleukin-7 (IL-7) Levels
Mean levels of the inflammatory serum biomarker IL-7 is compared between study arms.
Measured: Week 1, Week 2
Interleukin-8 (IL-8) Levels
Mean levels of the inflammatory serum biomarker IL-8 is compared between study arms.
Measured: Week 1, Week 2
Interleukin-10 (IL-10) Levels
Mean levels of the inflammatory serum biomarker IL-10 is compared between study arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 2
Tumor Necrosis Factor (TNF)-Alpha Levels
Mean levels of the inflammatory serum biomarker TNF-alpha are compared between study arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Number of Participants Surviving
Overall survival is defined as days from randomization to death and censored at last follow up.
Measured: Up to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start18 Nov 2020
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Verastem, Inc.
- Responsible party
- Principal investigator, Edmund Waller, Emory University
- Investigators
- Edmund Waller, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487886
- Sponsor's protocol ID
- STUDY00000701
- Acronym
- DAMPEN-CI
- Status last verified
- Mar 2023
- First submitted
- 23 Jul 2020
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection
- ClinicalTrials.gov ID
- NCT04487886
- Acronym / sponsor ID
- DAMPEN-CI / STUDY00000701
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Verastem, Inc.
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duvelisib | Experimental | Drug: DuvelisibParticipants with severe COVID-19 who do not require mechanical ventilation randomized to receive duvelisib for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with severe COVID-19 who do not require mechanical ventilation randomized to receive a placebo to match duvelisib for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibAlso: CopiktraDuvelisib 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. | Drug | Duvelisib |
| PlaceboA placebo to match duvelisib will be taken orally twice per day for 14 days. | Drug | Placebo |
Primary outcome
Number of Participants Requiring Mechanical Ventilation or Dying
Time frame: Up to Day 29
This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.
28 secondary outcomes
Days to Recovery
Time frame: Up to Day 29
Duration of Hospitalization
Time frame: Up to Day 29
Days on Study Drug
Time frame: Up to Day 29
Total Doses of Study Drug
Time frame: Up to Day 29
Number of Participants Dying
Time frame: Up to Day 29
Number of Participants Transferred to ICU
Time frame: Up to Day 29
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Time frame: Between Day 14 and 28, Between Day 29 and 60
Number of Grade III-V Adverse Events
Time frame: Up to Day 29
Number of Secondary Bacterial or Viral Infections
Time frame: Up to Day 29
T Helper 1 (Th1) T Cell Frequency
Time frame: Week 1, Week 2
Th17 T Cell Frequency
Time frame: Week 1, Week 2
Interleukin-2 (IL-2) Levels
Time frame: Week 1, Week 2
Interleukin-2 Receptor (IL-2R) Levels
Time frame: Week 1, Week 2
Interleukin-6 (IL-6) Levels
Time frame: Week 1, Week 2
Interleukin-7 (IL-7) Levels
Time frame: Week 1, Week 2
Interleukin-8 (IL-8) Levels
Time frame: Week 1, Week 2
Interleukin-10 (IL-10) Levels
Time frame: Week 1, Week 2
Interferon Gamma-induced Protein 10 (IP-10) Levels
Time frame: Week 1, Week 2
Macrophage Inflammatory Protein 1alpha (MIP-1a) Levels
Time frame: Week 1, Week 2
Monocyte Chemoattractant Protein-1 (MCP-1) Levels
Time frame: Week 1, Week 2
Granulocyte Colony-stimulating Factor (G-CSF) Levels
Time frame: Week 1, Week 2
Tumor Necrosis Factor (TNF)-Alpha Levels
Time frame: Week 1, Week 2
Gene Expression Profile of Regulatory T Cells (Tregs)
Time frame: Week 1, Week 2
Gene Expression Profile of Cluster of Differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)+
Time frame: 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)+
Time frame: Week 1, Week 2
Gene Expression Profile of Cluster of Differentiation 14 (CD14)+ Cluster of Differentiation (CD16)+ Monocytes
Time frame: Week 1, Week 2
Immunoglobin G (IgG) Antibodies
Time frame: Week 4
Number of Participants Surviving
Time frame: Up to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund Waller, MD, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvelisib in people with COVID-19, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Requiring Mechanical Ventilation or Dying (time frame: Up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.