Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19

Phase 2

Terminated

• Conditions: Solid Tumor; Sars-CoV2; Hematological Malignancy
• Interventions: Drug: BMS-986253

• Registration Number: NCT04347226
• Lead Sponsor: Columbia University

Brief Summary

This study is for patients that are hospitalized for Coronavirus Disease 2019 (COVID-19). The purpose of this study is to see whether neutralizing interleukin-8 (IL-8) with BMS-986253 can help improve the health condition of participants infected with COVID-19. This is the first in-human study of this investigational product specifically in patients with severe COVID-19. Currently there are no FDA approved medications that improve the chance of survival in patients diagnosed with COVID-19. However there are usual treatments currently being used to help treat COVID-19 patients and BMS-986253 will be compared to these standard of care treatments in this study.

Detailed Description

This is a single center, randomized, open-label, phase 2 trial to evaluate the time-to-improvement in the 7 point ordinal scale following treatment with anti-IL-8 therapy (BMS-986253) compared to standard of care in hospitalized patients with COVID-19 respiratory disease. Patients will be randomized 2:1 to receive either BMS-986253 or standard of care. Patients randomized to treatment with BMS-986253 will receive between 1-3 doses of therapy depending on their clinical status. Participants will be assessed daily while in the hospital and with then be followed for up to 1 year after discharge.

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Study Start: 2020-04-16
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Results First Submitted: 2025-04-10
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Results First Posted: 2025-05-22
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-986253	BMS-986253	BMS-986253 2400mg IV

Primary Outcome Measures

Name	Time	Method
Time to Improvement in the 7-point Ordinal Scale	Up to 10.5 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Requiring ICU Admission	Up to 10.5 months	The 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.
Mortality at 1 Month	1 month	Number of participants who have died 1 month from the time of start of treatment
Time to Death	Up to 10.5 months	The 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.
Time to Intubation	Up to 10.5 months	The 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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States