Covid-19 Living Data

Trial NCT04497987
Publication Cohen M, BLAZE-2, 2021
Dates: 8/2/2020 to 11/20/2020
Funding: Mixed (Eli Lilly and Co ; National Institute of Allergy and Infectious Diseases )
Conflict of interest:

Methods
	RCT
	Location : Multicenter / USA Follow-up duration (days): 56
Inclusion criteria	Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (?)7 days prior to randomization ; men or non-pregnant women who agree to contraceptive requirements ; agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities ; venous access sufficient to allow intravenous infusions and blood sampling ; participant or legally authorized representative give signed informed consent.
Exclusion criteria	Recovered from confirmed COVID-19 disease or asymptomatic infection ; Prior history of a positive SARS-CoV-2 serology test ; History of convalescent COVID-19 plasma treatment ; Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine ; Previous receipt of SAR-CoV-2-specific monoclonal antibodies ; Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study.
Interventions
	Treatment Bamlanivimab (LY-CoV555) (*) Duration : Once-off
	Control Placebo Duration : Once-off
Participants
	Randomized 1175 participants (n₁=588 / n₂= 587)
	Characteristics of participants N=1175 Mean age : NR 244 males
Primary outcome
	In the register Percentage of Participants with COVID-19 within 21 Days of Detection [ Time Frame: Baseline through Week 8 ]
	In the report
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes
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
General comment	In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were some differences in primary outcome and outcome timepoints between the original registry and updated registry (post-recruitment), and between the original protocol and final protocol (amended during the study), but the database was not unlocked until completion of follow up for all participants, overseen by the National Institute of Allergy and Infectious Diseases data and safety monitoring board. Some outcomes in the registry (hospitalizations, ER visits, pharmacokinetic) are not reported. The article reports results from an 8-week evaluation period amongst a prevention population from an ongoing, multi-part study that also includes a treatment population (to be reported separately) and a population with risk factors. The study (n = 966 in the prevention population) did not achieve its target sample size (approximately 1300 in the prevention population).