Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID-19: A phase 2a, open-label, single-dose escalation study.
Manon L M PrinsJohan L van der PlasMaurits F J M VissersCécile L BerendsGaby TreschMarianne SoergelElena FernándezNikita van den BergeDaniël DuijsingsChristof ZittVaia StavropoulouMaya ZimmermannRoxana F DrakeJacobus BurggraafGeert H GroeneveldIngrid M C KamerlingPublished in: British journal of clinical pharmacology (2022)
Single-dose intravenous administration of 225 or 600 mg of ensovibep appeared safe and well tolerated in patients with mild-to-moderate COVID-19. Ensovibep showed favourable pharmacokinetics in patients and the pharmacodynamic results warrant further research in a larger phase 2/3 randomized-controlled trail.
Keyphrases
- respiratory syndrome coronavirus
- sars cov
- open label
- coronavirus disease
- phase ii
- phase iii
- end stage renal disease
- clinical trial
- phase ii study
- newly diagnosed
- double blind
- study protocol
- chronic kidney disease
- placebo controlled
- peritoneal dialysis
- prognostic factors
- randomized controlled trial
- high dose
- patient reported outcomes