Covid-19 Living Data

Trial NCT04790786
Publication McCreary E, OPTIMISE-C19, 2021 (preprint)
Dates: 3/10/2021 to 6/25/2021
Funding: Public/non profit (Internal funding from the UPMC Hospital System. The U.S. federal government provided the monoclonal antibody treatments reported in this manuscript.)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Adult and pediatric patients (12 years of age and older weighing at least 40 kg); positive SARS-CoV-2 antigen or PCR test; within 10 days of symptom onset; high risk of disease progression defined as patients who meet at least one of the following criteria: Body Mass Index (BMI) â¥35; Chronic Kidney Disease; diabetes; immunosuppressive disease; currently receiving immunosuppressive treatment; â¥65 years of age; â¥55 years of age AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease; 12-17 years of age AND have: BMI â¥ 85th percentile for their age and gender based on CDC growth charts, OR sickle cell disease, OR congenital or acquired heart disease, OR neurodevelopmental disorders (e.g., cerebral palsy), OR a medical-related technological dependence, for example, tracheostomy or gastrostomy), OR asthma, reactive airway, or other respiratory disease that requires daily medication for control.
Exclusion criteria	Hospitalized for the treatment of COVID-19; Require oxygen therapy for the treatment of COVID-19; Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity; Have a known hypersensitivity to any antibody ingredient
Interventions

	Treatment 1 LY-CoV555
	Control Casirivimab+Imdevimab (REGN-COV2)
	Treatment 3 LY-CoV555+LY-CoV016
Participants
	Randomized 1935 participants n₁=128/ n₂=922/ n₃=885
	Characteristics of participants N=1935 Mean age : 55.6 894 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
	In the register Alive and Free from Hospitalization [ Time Frame: 28 days after initial participation ]
	In the report NR
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated NR
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 pre-print article, the trial protocol, statistical analysis plan, registry and supplementary materials were used in data extraction and assessment of risk of bias. The primary outcome reported in the paper reflects the primary outcome indicated in registry and protocol. Ten laboratory and immunological outcomes in the registry were not reported. The study (n = 2466) did not achieve its target sample size (n = 5000) at time of reporting because two of the three study treatments were withdrawn, so that patients could no longer be randomized to these. The U.S. Department of Health and Human Services halted distribution of bamlanivimab alone on March 25, 2021, and of bamlanivimab-etesevimab on June 25, 2021, due to concern of lack of efficacy against certain SARS-CoV-2 variants that were predominant in the U.S. at those times. Recruitment continues to the Casirivimab + Imdevimab and Sotrovimab arms.