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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
University Hospital Tübingen
Tübingen, Germany
RECRUITINGProportion of patients with Treatment-Emergent Adverse Events (TEAEs)
Time frame: through Day 28
Proportion of patients with Serious Adverse Events (SAEs)
Time frame: through Day 28
Proportion of patients with Adverse Events of Special Interest (AESI)
Time frame: through Day 28
Secondary efficacy endpoint: Proportion of patients with disease progression
Proportion of patients who are not alive or have respiratory failure
Time frame: through Day 28
Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2
Time frame: through Day 28
Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101
Time frame: through Day 60
Assessment of PK parameter: Time to Cmax (tmax) for COR-101
Time frame: through Day 60
Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101
Time frame: through Day 60
Assessment of PK parameter: Clearance (CL) for COR-101
Time frame: through Day 60
Assessment of PK parameter: Mean residence time (MRT) of COR-101
Time frame: through Day 60
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Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR
Time frame: through Day 21
Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101
Time frame: through Day 60