Living meta-analysis and evidence synthesis of therapies for COVID-19

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OPTIMISE-C19 (bamlanivimab-etesevimab vs casirivimab-imdevimab), 2021 NCT04790786

bamlanivimab/etesevimab (n=-9) vs. casirivimab/imdevimab (Ronapreve) (n=-9)

randomized controlled trial   high risk of bias

Studied treatment

bamlanivimab-etesevimab

Control treatment

casirivimab-imdevimab

Patients

COVID 19 outpatients

Method

open- label

Pennsylvania, USA

All pharmacies supplying all infusion sites had equal opportunity to order any available mAb from a central supply facility. All mAb were ordered by prescribers as a generic referral order

Remark

BLAZE-4, 0 NCT04634409

bamlanivimab/etesevimab (n=158) vs. placebo (n=153)

randomized controlled trial   risk of bias NA

Studied treatment

bamlanivimab 700 mg and etesevimab 1,400 mg

Control treatment

placebo

3 arms : 700 mg bamlanivimab and 1,400 mg etesevimab, 2,800 mg bamlanivimab and 2,800 mg of etesevimab, and placebo

Patients

COVID 19 outpatients

Method

double-blind

phase 2, ongoing, interim analysis (without precision about prespecification and type 1 risk control)

Remark

UNPUBLISHED preliminary data, from FDA EUA fact sheet. October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).

BLAZE-1 phase 2 (combination with etesevimab), 2020 NCT04427501

bamlanivimab/etesevimab (n=112) vs. placebo (n=156)

randomized controlled trial   some concerns about risk of bias

Studied treatment

bamlanivimab 2800 mg and etesevimab 2800 mg

Control treatment

placebo

5 arms: placebo, bamlanivimab 700 mg, 2800 mg, and 7000 mg and 2800 mg of bamlanivimab and 2800 mg of etesevimab

Patients

COVID 19 outpatients

Method

double-blind

Phase 2. Exploratory trial, originally designed as a safety and biomarker study.

Remark

October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).

BLAZE-1 phase 3 (combo), 2021 NCT04427501

bamlanivimab/etesevimab (n=518) vs. placebo (n=517)

randomized controlled trial   some concerns about risk of bias

Studied treatment

bamlanivimab 2,800 mg plus etesevimab 2,800 mg
single intravenous (IV) infusion within 3 days of having a positive result on a SARS-CoV-2 virologic test

Control treatment

placebo

Patients

COVID 19 outpatients

Participants were excluded if they had a saturation of oxygen (SpO2) ≤93% on room air, respiratory rate ≥30 breaths/min, or heart rate ≥125 bpm

Method

double-blind

Remark

October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).