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
Drug: COR-101
Administered intravenously (IV) single dose
Drug: Placebo
Administered intravenously (IV) single dose
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
University Hospital Tübingen
Tübingen, Germany
Investigator: Helmut Salih
Marie-Ann Dhaen
+4981313563724
m.dhaen@corat-therapeutics.com
Helmut Salih, Principal Investigator
University Hospital Tübingen