Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Novartis Pharmaceuticals
With
Primary objectives: Part A: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8. Part B: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29. Secondary objectives: Part A: The secondary objectives of this Part are: * To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29 * To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29 * To evaluate safety and tolerability of ensovibep * To characterize the pharmacokinetics (PK) of ensovibep Part B: The secondary objectives of this Part are: * To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8 * To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29 * To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (PK, efficacy and safety) * To evaluate safety and tolerability of ensovibep Although Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
