Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19

Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients

Primary objectives Part 1:

- To evaluate the safety and tolerability of COR-101 compared to placebo

Secondary objectives Part 1:

• To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19
• To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

Key Inclusion Criteria:

• Hospitalized for COVID-19 illness for ≤72 hours
• Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test
• Presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID19 prior to study treatment

Key Exclusion Criteria:

• Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19
• In the opinion of the investigator, is not likely to survive for >48 hours beyond Day 1
• New onset stroke or seizure disorder during hospitalization and prior to Day 1
• History of relevant CNS pathology or current relevant CNS pathology