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

NCT04347226 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAS9881
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Sars-CoV2; Hematological Malignancy

Keywords

COVID-19; coronavirus; corona virus; COVID

Outcome Measures

Primary Outcomes (1)

• Time to Improvement in the 7-point Ordinal Scale

  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.

  Up to 10.5 months

Secondary Outcomes (4)

• Time to Death

  Up to 10.5 months

• Time to Intubation

  Up to 10.5 months

• Proportion of Patients Requiring ICU Admission

  Up to 10.5 months

• Mortality at 1 Month

  1 month

Study Arms (2)

BMS-986253

EXPERIMENTAL

BMS-986253 2400mg IV

Drug: BMS-986253

Standard of Care treatment

NO INTERVENTION

Usual treatment of COVID-19 per study physician discretion

Interventions

BMS-986253 DRUG

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).

BMS-986253

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult ≥ 18 years of age at time of enrollment.
• Confirmed diagnosis of SARS-CoV-2 infection ≤ 14 days prior to registration.
• Inpatient hospitalization (or documentation of a plan to admit to the hospital if the patient is in the emergency department)
• Evidence of pneumonia by chest radiographs, chest CT OR chest auscultation (rales, crackles).
• Severe respiratory disease (oxygen saturation ≤93% on room air and requiring supplemental oxygen) OR critical respiratory disease (requiring non-rebreather, non-mechanical/mechanical ventilation, high-flow nasal cannula, ICU admission).
• Patients can continue their anti-cancer therapy at the discretion of the treating physician.
• Adequate laboratory tests including:
• absolute neutrophil count (ANC) \>500 cells/mm3
• Platelet count \>20,000 cells/mm3
• Serum total bilirubin \<1.5 × upper limit of normal (ULN)
• alanine aminotransferase (ALT) \<5 × ULN
• aspartate aminotransferase (AST) \<5 × ULN
• Age and Reproductive Status
• Males and females, aged at least 18 years old
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment.

You may not qualify if:

• Treatment with anti-IL-6, anti-IL-6R antagonists or Janus kinase inhibitor (JAKi) within 48 hours of first dose of study treatment.
• No other investigational therapies with the intent to treat the patient's COVID-19 can be administered while the patient is enrolled in the study.
• o Exception is remdesivir, hydroxychloroquine or other treatments being used as compassionate use for COVID-19.
• Expected non-COVID-related survival of \< 2 months.
• Ongoing systemic immunosuppressive therapy ≤ 14 days prior to study treatment administration (except for adrenal replacement steroid doses ≤ 10mg daily prednisone equivalent in the absence of active autoimmune disease or a short course of steroids (\<5 days) up to 7 days prior to initiating study treatment).
• Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment
• History of severe hypersensitivity reaction to any monoclonal antibody (mAb)
• Multi-organ failure requiring vasopressors or continuous veno-venous hemofiltration (CVVH) or extracorporeal membrane oxygenation.
• No active systemic bacterial or fungal infection o Patients with a history of positive bacterial or fungal cultures but on enrollment do not have suspected or known active systemic bacterial or fungal infections are permitted.

Sponsors & Collaborators

• Columbia University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; COVID-19; Coronavirus Infections

Interventions

HuMax-IL8

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mark N. Stein, MD
• Organization: Columbia University

mns2146@cumc.columbia.edu

917-658-2771

Study Officials

• Mark N Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine at the Columbia University Medical Center

Model Details: Participants will receive either BMS-986253 2400mg intravenous (IV) at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if continued severe respiratory disease) or standard of care treatment.

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 15, 2020
• Study Start: April 16, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Locations

US (1)