Publication BLAZE-1 - Gottlieb R, JAMA (2021) (published paper)
Dates: 2020-06-17 to 2020-09-03
Funding: Private (Eli Lilly and Company)
Conflict of interest: Yes
Blinding: Participants, outcome assessor and health care pro
Multicenter / USA |
Follow-up duration (days): 29
Bamlanivimab 700 mg
700 mg IV single dose for 1 hour
Bamlanivimab 2800 mg
2800 mg IV single dose for 1 hour
Bamlanivimab 7000 mg
7000 mg IV single dose for 1 hour
LY-CoV555: 2800 mg IV single dose for 1 hour
LY-CoV016: 2800 mg IV single dose for 1 hour
Bamlanivimab 700 mg=104
Bamlanivimab 2800 mg=109
Bamlanivimab 7000 mg=104
|Characteristics of participants|
Mean age : NR
Severity : Mild: n= 577/ Asymptomatic: n=0
Number of vaccinated participants: NR
|In the register|
Percentage of Participants Who Experience COVID-Related Hospitalization or Death from Any Cause [ Time Frame: Baseline through Day 29 ];
Change from Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [ Time Frame: Baseline, Day 11 ];
Percentage of Participants with SARS-CoV-2 Viral Load Greater than a Prespecified Threshold [ Time Frame: Day 7 ]
|In the report|
Change in SARS- CoV-2 log viral load from baseline to day 11 (+/-4 days).
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to the published article, the trial registry, study protocol, statistical analysis plan, and supplementary materials were used in data extraction and assessment of risk of bias. Two outcomes described as primary in the trial registry are described as secondary in the protocol and reported as secondary outcomes. Otherwise there were no substantive differences between the published article and the trial registry, study protocol ad statistical analysis plan. The database lock occurred when the last patient randomized to treatment of bamlanivimab and etesevimab reached day 29. As a result, the target sample size specified in the registry was not achieved.
This is a phase 2/3 trial of previously published trial, Chen P, N Engl J Med, 2020 included in this review.
Quote: "Interim results from the Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies (BLAZE-1) trial with data for the 3 monotherapy doses of the neutralizing antibody bamlanivimab have been published. The current report presents the final data set for patients randomized to the 4 treatment groups and the placebo group in the initial portion of the trial, including findings for the bamlanivimab and etesevimab combination group, the 3 bamlanivimab monotherapy groups, and the placebo group."
This study was updated on November 3rd, 2022 with the results published in the trial registry.