Trial NCT04427501
Publication Gottlieb R, BLAZE-1, 2021 (published paper)
Dates: 6/17/2020 to 9/3/2020
Funding: Private (Eli Lilly and Company)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / USA Follow-up duration (days): 29 | |
Inclusion criteria | 1. Are ≥18 years of age at the time of randomization
2. Are currently not hospitalized 3. Have one or more mild or moderate COVID-19 symptoms i. Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms, or viii. Shortness of breath with exertion 4. Must have sample collection for first positive SARS-CoV-2 viral infection determination ≤3 days prior to start of the infusion 5. Are men or non-pregnant women; Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies 6. Understand and agree to comply with planned study procedures 7. Agree to the collection of nasopharyngeal swabs and venous blood 8. The participant or legally authorized representative give signed informed consent |
Exclusion criteria | 9. Have SpO2 ≤93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA resource page, WWW) 10. Require mechanical ventilation or anticipated impending need for mechanical ventilation 11. Have known allergies to any of the components used in the formulation of the interventions 12. Have hemodynamic instability requiring use of pressors within 24 hours of randomization 13. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention 14. Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days 15. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study. 16. Have a history of a positive SARS-CoV-2 serology test 17. Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study 18. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing 19. Have received treatment with a SARS-CoV-2 specific monoclonal antibody 20. Have a history of convalescent COVID-19 plasma treatment 21. Have participated in a previous SARS-CoV-2 vaccine study 22. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. 23. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study 24. Are pregnant or breast feeding 25. Are investigator site personnel directly affiliated with this study. |
Interventions | |
Treatment 1 LY-CoV555 700 mg | |
Control Placebo | |
Treatment 3 LY-CoV555 2800 mg | |
Treatment 4 LY-CoV555 7000 mg | |
Treatment 5 LY-CoV555+LY-CoV016 | |
Participants | |
Randomized 592 participants n1=104/ n2=161/ n3=109/ n4=104n5=114 | |
Characteristics of participants N=592 Mean age : NR 262 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
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). | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated No |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment |
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: |