Covid-19 Living Data

Trial NCT04427501
Publication BLAZE-1 - BLAZE-1, Unpublished (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: double blinding
	Location : Multicenter / USA Follow-up duration (days): 85
Inclusion criteria	Are currently not hospitalized Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion Are males or females, including pregnant females who agree to contraceptive requirements Understand and agree to comply with planned study procedures Agree to the collection of nasopharyngeal swabs and venous blood The participant or legally authorized representative give signed informed consent and/or assent Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening: Are pregnant Are ≥65 years of age Have a body mass index (BMI) ≥35 Have chronic kidney disease (CKD) Have type 1 or type 2 diabetes Have immunosuppressive disease Are currently receiving immunosuppressive treatment or Are ≥55 years of age AND have: cardiovascular disease (CVD), OR hypertension, OR chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening: Are pregnant Have a body mass index (BMI) ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm Have sickle cell disease Have congenital or acquired heart disease Have neurodevelopmental disorders, for example, cerebral palsy Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19) Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control Have type 1 or type 2 diabetes Have chronic kidney disease Have immunosuppressive disease, or Are currently receiving immunosuppressive treatment
Exclusion criteria	Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19 Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19 Have known allergies to any of the components used in the formulation of the interventions Have 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 Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing Have received treatment with a SARS-CoV-2 specific monoclonal antibody Have received convalescent COVID-19 plasma treatment Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine 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 Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Mothers who are breast feeding
Interventions
	Treatment Bamlanivimab+Etesevimab 350/700mg intravenously single dose
	Control Placebo
Participants
	Randomized participants : Placebo=141 Bamlanivimab+Etesevimab=213
	Characteristics of participants N= 354 Mean age : NR 178 males Severity : Mild: n= 354/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo [ Time Frame: Day 7 ]
	In the report NR
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
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	Low
General comment	This is an unpublished trial whose results have been reported in ClinicalTrials.gov. The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. This study reports on the phase 3 results of the Bamlanivimab 350 mg and Etesevimab 700 mg arm. Time to negative conversion and time to clinical improvement outcomes were reported but the HRs do not include the CI.