Covid-19 Living Data

Trial NCT04427501
Publication BLAZE-1 - Dougan M, N Engl J Med (2021) (published paper)
Dates: 2020-09-04 to 2020-12-08
Funding: Private (Eli Lilly)
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / USA Follow-up duration (days): 29
Inclusion criteria	Tested positive for SARS-CoV-2 by means of either direct antigen or nucleic acid identification Have one or more mild or moderate COVID-19 symptoms 12 to 17 years of age with at least one of the following risk factors: BMI in at least the 85th percentile for age and sex, according to CDC growth charts sickle cell disease congenital or acquired heart disease neurodevelopmental disorders such as cerebral palsy dependence on a medical-related mechanical device or procedure such as tracheostomy, gastrostomy, or positive-pressure ventilation (not related to Covid-19) asthma, a reactive airway, or another chronic respiratory disease type 1 or type 2 diabetes mellitus and an immunocompromised condition or receipt of an immunosuppressive treatment. At least 18 years of age with at least one of the following risk factors: age of at least 65 years, a BMI of at least 35, chronic kidney disease, diabetes mellitus type 1 or type 2, immunosuppressive disease or receipt of immunosuppressive treatment, and an age of at least 55 years with cardiovascular disease, hypertension, or chronic obstructive pulmonary disease or another chronic respiratory disease.
Exclusion criteria	SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA May 2020) Require mechanical ventilation or anticipated impending need for mechanical ventilation known allergies to any of the components used in the formulation of the interventions hemodynamic instability requiring use of pressors within 24 hours of randomization 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 any co-morbidity requiring surgery within <7 days, or that is considered life threatening within 29 days any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study a history of a positive SARS-CoV-2 serology test a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing received treatment with a SARS-CoV-2 specific monoclonal antibody received convalescent COVID-19 plasma treatment 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 concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study breast feeding investigator site personnel directly affiliated with this study body weight <40 kg.
Interventions
	Treatment Bamlanivimab+Etesevimab 2800 mg/2800mg IV single dose
	Control Placebo
Participants
	Randomized NR Analyzed 1035 participants Bamlanivimab+Etesevimab=518 Placebo=517
	Characteristics of participants N= 1035 Mean age : NR 0 males Severity : Mild: n= 800/ Asymptomatic: n=* Number of vaccinated participants: NR
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 ]; Pharmacokinetics (PK): Area Under the Concentration-time Curve from 0 to Infinity (AUC0-inf) for both LY3819253 and LY3832479 [ Time Frame: Baseline through Day 85 ]; Percentage of Participants who Experience a Serious Adverse Event(s) SAE(s) [ Time Frame: Baseline through Day 85 ]
	In the report Covid-19–related hospitalization (acute care for ≥24 hours) or death from any cause by day 29
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: N
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 prospective registry, protocol and statistical analysis plan and supplementary materials were used in data extraction and assessment of risk of bias. Some primary outcomes in the registry are reported as secondary outcomes in the report, and some secondary outcomes in the registry (proportion of patients demonstrating symptom resolution or improvement, pharmacokinetics) are not reported. Otherwise there were no substantive differences in population, procedures, interventions or outcomes between the registry, protocol and statistical analysis plan and the published article. The study achieved its target sample size. On November 3rd, 2022, this study was updated with results published in the trial registry.