Trial Outcomes & Findings for Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19 (NCT NCT04385849)
NCT ID: NCT04385849
Last Updated: 2024-09-05
Results Overview
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
1 participants
Primary outcome timeframe
3 days
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
Experimental Arm
N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
Placebo Arm
Sterile saline solution
Saline: Sterile saline solution
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental Arm
N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
Placebo Arm
Sterile saline solution
Saline: Sterile saline solution
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=1 Participants
N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
Placebo Arm
Sterile saline solution
Saline: Sterile saline solution
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 0 • n=99 Participants
|
—
|
70 years
STANDARD_DEVIATION 0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: All randomized subjects
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Outcome measures
| Measure |
Experimental Arm
n=1 Participants
N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
N-803: Recombinant human super agonist interleukin-15 (IL-15) complex
|
Placebo Arm
Sterile saline solution
Saline: Sterile saline solution
|
|---|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
0 Participants
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place