Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04347226|
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Sars-CoV2 Hematological Malignancy||Drug: BMS-986253||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 2 Study of Anti-IL-8 Therapy Versus Standard of Care in the Treatment of Hospitalized Patients With Severe COVID-19|
|Actual Study Start Date :||April 16, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
BMS-986253 2400mg IV
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).
No Intervention: Standard of Care treatment
Usual treatment of COVID-19 per study physician discretion
- Time to Improvement in the 7-point ordinal scale [ Time Frame: 1 year ]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.
- Time to Death [ Time Frame: 1 year ]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 [ Time Frame: 1 year ]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.
- Proportion of patients requiring ICU admission [ Time Frame: 1 year ]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.
- Percentage Rate of Mortality at 1 month [ Time Frame: 1 month ]Percentage of participants who have died 1 month from the time of start of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347226
|Contact: Research Nurse Navigatoremail@example.com|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Research Nurse Navigator 212-342-5162 firstname.lastname@example.org|
|Principal Investigator: Matthew Dallos, MD|
|Principal Investigator:||Matthew Dallos, MD||Columbia University Irving Medical Center|