Trial Outcomes & Findings for A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19 (NCT NCT04415073)
NCT ID: NCT04415073
Last Updated: 2022-07-22
Results Overview
Respiratory failure was defined by need for mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation \>6 liters oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making was driven solely by resource limitation.
TERMINATED
PHASE2
1 participants
Day 29
2022-07-22
Participant Flow
This study was terminated by the Sponsor given enrollment challenges, partly attributable to the constantly changing novel coronavirus disease (COVID-19) treatment landscape. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Participant milestones
| Measure |
Axatilimab (SNDX-6352)
Axatilimab on Days 1 and 15, intravenous (IV) + standard of care (SOC)
|
Placebo
Matching placebo on Days 1 and 15, IV + SOC
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Day 29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Respiratory failure was defined by need for mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation \>6 liters oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making was driven solely by resource limitation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Participants achieving a ≥2 category improvement on a 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29 are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
The time to clinical improvement is defined as a national early warning score of ≤2 maintained for 24 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
The change from baseline at Day 29 or hospital discharge or death, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen is evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 15Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
The change from baseline at Day 15 in serum concentrations of interleukin 6 and c-reactive protein or hospital discharge or death is evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
This outcome measure evaluates the safety and tolerability of axatilimab within the same population. A summary of all serious adverse events and other adverse events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Day 29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Participants who required initiation of mechanical ventilation after study entry are analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
This outcome measure evaluates the antiviral effects of axatilimab in hospitalized adults by Day 15 or hospital discharge, whichever was sooner, with recently diagnosed SARS-CoV-2 infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29Population: This study was terminated by the Sponsor. Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
The serum concentration of axatilimab and presence of anti-drug antibodies is evaluated.
Outcome measures
Outcome data not reported
Adverse Events
Axatilimab (SNDX-6352)
Placebo
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