Trial Outcomes & Findings for Duvelisib to Combat COVID-19 (NCT NCT04372602)

NCT ID: NCT04372602

Last Updated: 2023-03-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Through 28 days

Results posted on

2023-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Duvelisib -Duvelisib 25 mg twice daily for up to 10 days.	Placebo -Placebo 25 mg twice daily for up to 10 days.
Overall Study STARTED	15	13
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Duvelisib -Duvelisib 25 mg twice daily for up to 10 days.	Placebo -Placebo 25 mg twice daily for up to 10 days.
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	1
Overall Study Transitioned to comfort care	0	1

Baseline Characteristics

Duvelisib to Combat COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duvelisib n=15 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=13 Participants -Placebo 25 mg twice daily for up to 10 days.	Total n=28 Participants Total of all reporting groups
Age, Continuous	63 years n=99 Participants	64 years n=107 Participants	63 years n=206 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants	13 Participants n=107 Participants	28 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) White	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	15 participants n=99 Participants	13 participants n=107 Participants	28 participants n=206 Participants

PRIMARY outcome

Timeframe: Through 28 days

Outcome measures

Outcome measures
Measure	Duvelisib n=15 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=13 Participants -Placebo 25 mg twice daily for up to 10 days.
Overall Survival as Measured by Number of Participants Alive Through 28 Days	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Through 28 days

Outcome measures

Outcome measures
Measure	Duvelisib n=15 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=13 Participants -Placebo 25 mg twice daily for up to 10 days.
Length of Hospital Stay	19 days Interval 7.0 to 28.0	24 days Interval 7.0 to 28.0

SECONDARY outcome

Timeframe: Through 28 days

Population: 1 participant was not evaluable in the placebo arm as the participant was not in the ICU.

Outcome measures

Outcome measures
Measure	Duvelisib n=15 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=12 Participants -Placebo 25 mg twice daily for up to 10 days.
Length of ICU Stay	19 days Interval 5.0 to 28.0	20.50 days Interval 7.0 to 28.0

SECONDARY outcome

Timeframe: Through 28 days

Population: 6 participants were not evaluable in the duvelisib arm as the participants were not on ventilators. 4 participants were not evaluable in the placebo arm as the participants were not on ventilators.

-For those on a ventilator at the time of randomization

Outcome measures

Outcome measures
Measure	Duvelisib n=9 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=9 Participants -Placebo 25 mg twice daily for up to 10 days.
Duration of Ventilator Use	16 days Interval 2.0 to 28.0	20 days Interval 11.0 to 28.0

SECONDARY outcome

Timeframe: Through 28 days

Population: 12 participants were not evaluable in the duvelisib arm as the participants did not receive vasopressors. 8 participants were not evaluable in the placebo arm as the participants did not receive vasopressors.

Outcome measures

Outcome measures
Measure	Duvelisib n=3 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=5 Participants -Placebo 25 mg twice daily for up to 10 days.
Duration of Vasopressors Use	9 days Interval 7.0 to 28.0	19 days Interval 9.0 to 28.0

SECONDARY outcome

Timeframe: Through 28 days

Population: 14 participants were not evaluable in the duvelisib arm as the participants did not receive renal replacement therapy. 9 participants were not evaluable in the placebo arm as the participants did not receive renal replacement therapy.

Outcome measures

Outcome measures
Measure	Duvelisib n=1 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=4 Participants -Placebo 25 mg twice daily for up to 10 days.
Duration on Renal Replacement Therapy	28 days Interval 28.0 to 28.0	19 days Interval 13.0 to 28.0

SECONDARY outcome

Timeframe: Through 28 days

-Defined as increase in viral load of \>0.5 log on two consecutive days, or \>1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing

Outcome measures

Outcome measures
Measure	Duvelisib n=15 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=13 Participants -Placebo 25 mg twice daily for up to 10 days.
Viral Kinetics as Measured by Virologic Failure	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Through 29 days

Outcome measures

Outcome measures
Measure	Duvelisib n=15 Participants -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=13 Participants -Placebo 25 mg twice daily for up to 10 days.
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 lower gastrointestinal hemorrhage	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 melena	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 mucositis oral	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 oral hemorrhage	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 pancreatitis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 rectal ulcer	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 upper gastrointestinal hemorrhage	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 vomiting	2 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 vomiting	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 fever	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 fever	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hypothermia	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 cholecystitis	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 bacteremia	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 conjunctivitis infective	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 lung infection	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 lung infection	1 Participants	4 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 sepsis	1 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 sinusitis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 tracheitis	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 tracheitis	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 urinary tract infection	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 acidosis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 acidosis	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hypercalcemia	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hyperglycemia	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hyperkalemia	1 Participants	3 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hyperkalemia	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hypernatremia	2 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hypernatremia	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hyperphosphatemia	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hypoalbuminemia	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hyponatremia	2 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 arthritis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 intracranial hemorrhage	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 stroke	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 syncope	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 delirium	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 acute kidney injury	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 acute kidney injury	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hematuria	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hematuria	1 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 cough	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 epistaxis	1 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 epistaxis	2 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hypoxia	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 pharyngeal hemorrhage	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 pneumothorax	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 respiratory failure	6 Participants	5 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 moisture associated skin damage	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 pressure ulcer	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 rash acneiform	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 skin tear	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 skin ulceration	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 subcutaneous emphysema	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hematoma	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 hypotension	2 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 hypotension	3 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 peripheral ischemia	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 thromboembolic event	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 thromboembolic event	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 urinary tract infection	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 alanine aminotransferase increased	2 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 alkaline phosphatase increased	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 aspartate aminotransferase increased	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 blood bilirubin increased	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 elevated LFT NOS	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 platelet count decreased	2 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 anemia	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 anemia	1 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 leukocytosis	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 atrial fibrillation	1 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 cardiac arrest	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 pericarditis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 sinus bradycardia	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 sinus tachycardia	2 Participants	2 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 ventricular arrhythmia	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 middle ear inflammation	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 conjunctivitis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 corneal ulcer	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 colitis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 constipation	1 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 diarrhea	0 Participants	1 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 3/4/5 gastroparesis	1 Participants	0 Participants
Number of Adverse Events as Measured by CTCAE v. 5.0 Grade 1/2 ileus	2 Participants	0 Participants

Adverse Events

Duvelisib

Serious events: 6 serious events

Other events: 15 other events

Deaths: 6 deaths

Placebo

Serious events: 8 serious events

Other events: 13 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Duvelisib n=15 participants at risk -Duvelisib 25 mg twice daily for up to 10 days.	Placebo n=13 participants at risk -Placebo 25 mg twice daily for up to 10 days.
Cardiac disorders Cardiac arrest	6.7% 1/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	0.00% 0/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	7.7% 1/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Hepatobiliary disorders Cholecystitis	0.00% 0/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	7.7% 1/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Infections and infestations Lung infection	6.7% 1/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	15.4% 2/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Infections and infestations Sepsis	0.00% 0/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	7.7% 1/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Nervous system disorders Intracranial hemorrhage	6.7% 1/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	7.7% 1/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Nervous system disorders Stroke	0.00% 0/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	7.7% 1/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	40.0% 6/15 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.	38.5% 5/13 • Adverse events were collected from start of treatment through Day 29. All-cause mortality was collected from start of treatment through 6 months.

Other adverse events

Additional Information

John DiPersio, M.D., Ph.D.

Washington University School of Medicine

Phone: 314-454-8491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place