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BLAZE-1 phase 2 (monotherapy), 2020 NCT04427501

bamlanivimab monotherapy (n=101) vs. placebo (n=156)

randomized controlled trial

Bamlanivimab (LY-CoV555) 700 mg

placebo

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

COVID 19 outpatients

double-blind

Phase 2: exploratory trial, originally designed as a safety and biomarker study. Inconclusive for the primary endpoint.

As of April 2021, regulatory authorities recommend that bamlanivumab no longer be used because of the potential risk of treatment failure due to the circulation of resistant variants of SARS-CoV-2.

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

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

randomized controlled trial

bamlanivimab 2800 mg and etesevimab 2800 mg

placebo

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

COVID 19 outpatients

double-blind

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

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

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

placebo

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

double-blind

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).

Cov-2069 (Cohort B: positive SARS-CoV-2 RT-qPCR test result), 2021 NCT04452318

casirivimab/imdevimab (Ronapreve) (n=156) vs. placebo (n=158)

randomized controlled trial

Casirivimab 600 mg and imdevimab 600 mg
Single 1200 mg dose.

Placebo
Placebo at day 1 via subcutaneous injection.

COVID 19 outpatients

Double-blind.

112 sites in the US, Romania and Moldova.

The trial consists of a 1-day screening/baseline period, a 28-day efficacy assessment period (EAP), and a 7-month follow-up period.

*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.*

Cov-2067 Weinreich (1200mg) Cohort 1, 2020 NCT04425629

casirivimab/imdevimab (Ronapreve) (n=838) vs. placebo (n=840)

randomized controlled trial

REGEN-CO 1200mg (casirivimab and imdevimab) IV

Placebo

3 arms: placebo, REGEN-COV 2400mg (1200mg each antibody) and REGEN-COV 1200mg (600mg each antibody). (8,000 mg data were converted to a descriptive analysis)

COVID 19 outpatients

Patients ≥18 years of age and non-hospitalized, with a confirmed local SARS-CoV-2-positive diagnostic test result ≤72 hours and onset of any Covid-19 symptom, as determined by the investigator, ≤7 days before randomization, maintain O2 saturation ≥93% breathing room air, not have prior or current use of putative COVID-19 treatments (e.g. convalescent plasma, systemic corticosteroids or remdesivir) and not have been previously or currently hospitalized for treatment of COVID-19.

Double-blind.

Analysis in modified full analysis set (subjects with positive RT-qPCR test at baseline).The primary and two key secondary endpoints were tested hierarchically. The key secondary clinical endpoints were (1) the proportion of patients with ≥1 Covid-19-related hospitalization or all-cause death from day 4 through day 29 and (2) the time to Covid-19 symptoms resolution (19 of the 23 recorded symptoms).

*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.*

COMET-ICE, 2021 NCT04545060

sotrovimab (Xevudy; VIR-7831) (n=528) vs. placebo (n=529)

randomized controlled trial

Sotrovimab (VIR-7831, GSK4182136) as monotherapy
Intravenous infusion of sotrovimab 500 mg over 1 hour on day 1.

Placebo
Equal volume of saline placebo over 1 hour on day 1.

Patients were observed for approximately 2 hours after infusion.

COVID 19 outpatients

18 years of age and older with at least one of the following comorbidities: diabetes, obesity (BMI >30), chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate to severe asthma, or were 55 years of age and older regardless of comorbidities. Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

Double-blind.

57 centers in 5 countries: US, Brazil, Spain, Canada, Peru.

*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* data reported in FDA emergency use authorization (EUA), results from interim analysis.