meta|Evidence - COVID-19
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regdanvimab (Regkirona- CT-P59-Celltrion) (n=226) vs. placebo (n=111)
randomized controlled trial risk of bias NA
regdanvimab 40 mg/kg or 80 mg/kg
single infusion
placebo
3 arms: single infusion of regdanvimab at doses of 40 mg/kg, 80 mg/kg, or placebo
COVID 19 outpatients
double-blind
23 study centres across 4 countries, Republic of Korea, Romania, Spain and United States
The study was explorative and did not have a type-1 error controlled primary endpoint
preliminary unpublished results extracted from the EMA review document. *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.*
regdanvimab (Regkirona- CT-P59-Celltrion) (n=656) vs. placebo (n=659)
randomized controlled trial risk of bias NA
regdanvimab 40 mg/kg
Single infusion (drip) into a vein within 7 days of the start of COVID-19 symptoms of regdanvimab at dose of 40 mg/kg over 60 minutes.
placebo
Single infusion of placebo over 60 minutes.
COVID 19 outpatients
Adult patients with at least one or more symptoms of COVID-19 for ≤7 days, oxygen saturation >94% on room air, not requiring supplemental oxygen therapy. 66.9% of patients were at increased risk of progressing to severe COVID-19 and/or hospitalisation (defined as having at least one of the following risk factors for severe COVID-19: age >50 years; BMI >30 kg/m2; cardiovascular disease, including hypertension; chronic lung disease, including asthma; type 1 or type 2 diabetes mellitus; chronic kidney disease, including those on dialysis; chronic liver disease; and immunosuppressed, based on investigator’s assessment). Treatment was initiated after obtaining a positive SARS-CoV-2 viral infection determination.
double-blind
60 study centres across 14 countries, Hungary, Ireland, Italy, Mexico, North Macedonia, Peru, Poland
If the primary endpoint is statistically significant, the key secondary endpoints will be tested using the fixed sequence procedure in order to preserve the Type I error
preliminary unpublished results extracted from the EMA review document. *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.*
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