Trial NCT04790786
Publication OPTIMISE-C19 - McCreary E, medRxiv (2021) (preprint)
Dates: 2021-03-10 to 2021-06-25
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) ≥35
  • Chronic Kidney Disease
  • diabetes
  • immunosuppressive disease
  • currently receiving immunosuppressive treatment
  • ≥65 years of age
  • ≥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 ≥ 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
Bamlanivimab
700 mg intravenously once-off

Bamlanivimab+Etesevimab
Control
REGN-COV2
1200 mg + 1200 mg intravenously once-off

Participants
Randomized
NR

Analyzed
1935 participants Bamlanivimab =128
Bamlanivimab+Etesevimab=885
REGN-COV2=922
Characteristics of participants
N= 1935
Mean age : NR
894 males
Severity : Mild: n= 1935/ Asymptomatic: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Alive and Free from Hospitalization [ Time Frame: 28 days after initial participation ]
In the report
Hospital-free days up to day 28 after mAb treatment
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 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.