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

• Status: Recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corat Therapeutics Gmbh

Criteria

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