Trial Outcomes & Findings for Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19 (NCT NCT04347226)
NCT ID: NCT04347226
Last Updated: 2025-05-22
Results Overview
The time to improvement in the 7-point ordinal scale in patients treated with anti-IL-8 therapy compared to standard of care/controls. Measured from baseline to 2 point or greater improvement in 7-point ordinal scale.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 10.5 months
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
BMS-986253
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
14
|
|
Overall Study
COMPLETED
|
29
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19
Baseline characteristics by cohort
| Measure |
BMS-986253
n=29 Participants
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 Participants
Usual treatment of COVID-19 per study physician discretion
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
73.0 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
69.1 years
STANDARD_DEVIATION 12.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 10.5 monthsThe time to improvement in the 7-point ordinal scale in patients treated with anti-IL-8 therapy compared to standard of care/controls. Measured from baseline to 2 point or greater improvement in 7-point ordinal scale.
Outcome measures
| Measure |
BMS-986253
n=29 Participants
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 Participants
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Time to Improvement in the 7-point Ordinal Scale
|
12 days
Interval 5.0 to 57.0
|
6 days
Interval 4.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 10.5 monthsThe time to death will be defined as the time from onset from symptoms until death from any cause. Patients who are alive or lost to follow-up at the cut-off date will be censored from this analysis.
Outcome measures
| Measure |
BMS-986253
n=29 Participants
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 Participants
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Time to Death
|
30 days
Interval 15.0 to
upper limit of 95% Confidence Interval not reached due to insufficient number of participants with events
|
NA days
Interval 14.0 to
median and upper limit of 95% Confidence Interval not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 10.5 monthsThe time to intubation will be defined as the time from symptom onset until time of intubation. Any patients already intubated at enrollment will be censored from this analysis.
Outcome measures
| Measure |
BMS-986253
n=29 Participants
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 Participants
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Time to Intubation
|
11.5 days
Interval 10.2 to 14.2
|
3 days
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 10.5 monthsThe proportion of patients requiring intensive care unit (ICU) admission will be calculated as the number of patients requiring ICU admission over the course of their hospitalization over the number of evaluable patients.
Outcome measures
| Measure |
BMS-986253
n=18 Participants
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=4 Participants
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Proportion of Patients Requiring ICU Admission
|
9 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 monthNumber of participants who have died 1 month from the time of start of treatment
Outcome measures
| Measure |
BMS-986253
n=29 Participants
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 Participants
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Mortality at 1 Month
|
8 Participants
|
4 Participants
|
Adverse Events
BMS-986253
Serious events: 11 serious events
Other events: 20 other events
Deaths: 11 deaths
Standard of Care Treatment
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
BMS-986253
n=29 participants at risk
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 participants at risk
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Infections and infestations
Infections and infestation
|
17.2%
5/29 • Number of events 5 • Up to 10.5 months
|
14.3%
2/14 • Number of events 2 • Up to 10.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
20.7%
6/29 • Number of events 6 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/29 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
Other adverse events
| Measure |
BMS-986253
n=29 participants at risk
BMS-986253 2400mg IV
BMS-986253: BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
|
Standard of Care Treatment
n=14 participants at risk
Usual treatment of COVID-19 per study physician discretion
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Blood and lymphatic system disorders
Anemia
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Psychiatric disorders
Anxiety
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Cardiac disorders
Atrial Fibrillation
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
|
Investigations
Creatinine Increased
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Psychiatric disorders
Delirium
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Nervous system disorders
Depressed level of consciousness
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Eye disorders
Dry Eye
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.8%
4/29 • Number of events 4 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
General disorders
Edema limbs
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
General disorders
Fatigue
|
13.8%
4/29 • Number of events 4 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
General disorders
Fever
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.2%
5/29 • Number of events 5 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Cardiac disorders
Heart failure
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.9%
2/29 • Number of events 3 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.9%
2/29 • Number of events 9 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.9%
2/29 • Number of events 7 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.8%
4/29 • Number of events 11 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
1/29 • Number of events 2 • Up to 10.5 months
|
7.1%
1/14 • Number of events 2 • Up to 10.5 months
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.2%
5/29 • Number of events 6 • Up to 10.5 months
|
14.3%
2/14 • Number of events 2 • Up to 10.5 months
|
|
Infections and infestations
Infections and infestations
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
|
Infections and infestations
Lung infection
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
|
General disorders
Multi-organ failure
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Nervous system disorders
Nervous system disorders
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
General disorders
Pain
|
13.8%
4/29 • Number of events 5 • Up to 10.5 months
|
14.3%
2/14 • Number of events 2 • Up to 10.5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/29 • Up to 10.5 months
|
7.1%
1/14 • Number of events 1 • Up to 10.5 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Vascular disorders
Thromboembolic event
|
6.9%
2/29 • Number of events 2 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
|
Investigations
International Normalised Ratio (INR)
|
3.4%
1/29 • Number of events 1 • Up to 10.5 months
|
0.00%
0/14 • Up to 10.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place